BioTalk US – Biological Manufacturing Excellence
3rd – 4th June 2026, Framingham, USA

BioTalk is a leading annual meeting that brings together some of the most influential senior executives across the world’s Pharma & Bio-pharmaceutical Manufacturing community. The Talk will look at how companies and leaders are driving change within the industry to achieve manufacturing excellence through a series of keynotes, workshops, discussions, and debates.

Industry Leaders will be able to engage with fellow peers through a ‘closed door’ and ‘invitation only’ networking environment and discuss some of the industry’s key challenges in an intimate setting.

For more information, contact kamran.yousaf@gmstrats.com

     

           AGENDA HIGHLIGHTS

Digitalization, modeling, and machine learning: Pillars for development of next generation bioprocesses

The talk will describe how MSD is strategizing the use of digitalization, modeling, and machine learning tools for development of next generation bioprocesses.

  • The discussion would include the applicability and suitability of various tools relevant to data aggregation, modeling and simulation, as well as machine/deep learning.
  • Relevant case studies in different areas of development and manufacturing (upstream and downstream) would be shared.
  • Finally, Examples will be provided how the aforementioned techniques are being integrated with high throughput setups and PAT applications for speedy development and enhanced process understanding.

Sanjeev Ahuja Executive, Executive Director Biologics Process R & D, Merck

 

Faster Isn’t Enough: How Biotech Wins with Efficient Development

  • Over the last 10–20 years, biotech optimized for speed-to-market (compressed timelines, parallelized work, accelerated pathways); now that many “go faster” gains are saturated, the competitive edge shifts to doing more with the same (or less)—higher success rates, fewer handoffs, and less rework.
  • High-throughput automation (robotics, miniaturization, standardized assay/run recipes) increases experimental density and repeatability, reduces human variability, and enables rapid iterate-and-learn cycles with fewer failures and lower cost per decision.
  • Smart data infrastructure (instrument connectivity, metadata standards/ontologies, ELN/LIMS integration, governed data products) makes data findable and reusable, supports end-to-end traceability, and cuts cycle time lost to data wrangling, reconciliation, and “rediscovery.”
  • AI/ML tools turn integrated data into better decisions—prioritizing targets/compounds, optimizing experiments, detecting quality issues early, and forecasting manufacturability—so teams run fewer but higher-value experiments and de-risk programs earlier.

Terrence Dombrowsky, Senior Director, Head of Biotherapeutics Technology Development and Implementation, Takeda

 

Contextualized Data Framework to Accelerate Downstream Tech Transfer and CMC Readiness

  • Pain Point & Regulatory Context: Manual, unstructured document workflows impede searchability, traceability, and reusability; AI can extract history but not author source content—making structured data essential as FDA advances KASA and structured PQ/CMC submissions.
  • Scope & Rationale: Internal framework that contextualizes downstream experimental data and process definition was chosen to reduce cost, increase feedback speed, upskill scientists, and build the business case.
  • Architecture: Three layers of implementation includes Data Capture (templated ELNs; scientist-built UI for process parameters), Data Mapping (information model linking steps, parameters, attributes, and interdependencies), and Data Consumption (automated queries for advanced analysis).
  • Outcomes: Enables version-controlled tech transfer across scales, facility-fit and buffer-volume planning and faster investigations with traceable specs and supporting data

Lye Lin Lock, Associate Scientific Director, BMS

 

Modernizing upstream development to advance and accelerate process understanding and CMC excellence

  • Traditional upstream development is changing with advances in modelling and sensors.
  • Real time product quality data- how often and how well can this be achieved?
  • PAT tools that support process development modernization
  • Creating a CMC data package with AI, smart templates, and regulatory intelligence

Sarwat Khattak, Head of Cell Culture and Cell Line Development, Biogen

Continuous optical monitoring of antibody concentration and Rapid lateral-flow immunoassays for monitoring process and product parameters

  • Continuous optical monitoring of antibody concentration for early detection of breakthrough from large protein A columns, or for determination of titers in process streams
  • Enhanced control of rapid cycling processes or protein A column loading.
  • Rapid lateral-flow immunoassays for monitoring process and product parameters.
  • PAT information in 10 minutes instead of having to go to central analytical laboratories.

Richard Willson, Huffington-Woestemeyer Professor, University of Houston

Overcoming Buffer Bottlenecks Using Inline Buffer Formulation

  • Increasing cell culture titer (> 5 to 10 g/L) has led to a significant increase in downstream processing buffer consumption
  • A GMP scale Inline Buffer Formulation skid was designed to enhance manufacturing flexibility by enabling on-demand buffer production
  • This presentation will focus on the supporting lab studies and challenges for GMP implementation
  • The future goal of creating lab-scale inline buffer formulation models that predict GMP performance will also be discussed

Kheng Tee Ng, Senior Scientist, AbbVie

 

     

        REQUEST FULL AGENDA

This is my first BioTalk and I got the opportunity to share some of the sessions here, it has been a very intense two days, very short and compact, and brings a lot of subject matter experts on very relevant topics, my experience at BioTalk has been nice.

Nihal Tugcu

Global Head of Mammalian Platform, Sanofi

I think it was great! How many opportunities do we get in a year to get together with our peers and talk to them about the experiences they share. Overall, I believe that this is a great platform where we come together and share our experiences

Vijay Sharma

Head Biotherapeutics Tech Transfer, Takeda

Yiran Wang

Principal Scientist

Bristol Myers Squibb

Yiran is the Principal Scientist of Global Downstream Bioprocess Development at BMS. With 10 years of experience in the protein chromatography field, she has contributed many good works and publications to the community. Currently, she leads a team of scientists focusing on downstream process development, technology transfer, and in-process control strategies for biologics. Her team is actively involved with multiple early- to late-stage pipeline biologics products.

Yi Liu

Director of Process Development and Partnering Projects

Bayer

Yi Liu is a biotechnology leader currently serving as Director of Process Development and Partnering Projects at Bayer. With her career experience in the biopharmaceutical industry, she specializes in leading CMC teams to advance complex biologics (including protein, gene therapy, and vaccine development) from research and development through clinical phases and into commercialization.

Yi Liu had a PhD in Biochemistry, Before Bayer, she worked at MedImmune (Astra Zenica) as Senior downstream development scientist, In 2013 since she joined Bayer, she has led several protein pipeline molecules downstream process development from early to late clinical phase and process validation. She also led AAV gene therapy program and support cell therapy modalities. Recently, she led an external partner’s CMC project from process transfer, manufacturing to PPQ & launch.

Woo Ahn

Principal Scientist

Sanofi

Woo Ahn earned his Ph.D. in Chemical Engineering from the University of Delaware in 2012, where he focused on quantifying CHO cell metabolism using mass spectrometry and metabolic flux analysis. He completed postdoctoral research at MIT from 2012 to 2016, studying cancer metabolism. Woo joined Sanofi in 2016 and is currently a Principal Scientist in the MSAT organization. He is working on second-generation cell culture process development, commercial program support, and technology transfer. His current work also includes implementing process analytical technology (PAT) and developing hybrid models to advance process understanding, monitoring, and control. Woo’s expertise centers on optimizing mammalian cell culture performance and enabling robust, scalable upstream processes for biologics manufacturing.

Abstract

We developed an integrated Hamilton-based glucose control framework that enables predictive and automated glucose feeding for fed batch mammalian cell culture. Real time glucose measurements were coupled to a glucose flux analysis platform, which continuously processed updated sensor data to calculate external fluxes. These flux estimates informed a predictive feeding algorithm designed to maintain optimal glucose availability throughout the culture process.
Automated glucose supplementation was successfully demonstrated using Hamilton in situ glucose sensor feedback control. A soft sensor approach was incorporated to reduce prediction noise and improve the stability of flux calculations. Together, the combined glucose sensor–soft sensor system enhances real time process understanding, supports consistent glucose control trajectories, and reduces the need for manual intervention.
Overall, this framework illustrates the potential for scalable, data driven, and partially autonomous feeding strategies that improve robustness and efficiency during upstream process development.

Richard Willson

Huffington-Woestemeyer Professor

University of Houston

Richard Willson is Huffington-Woestemeyer Professor of Chemical & Biomolecular Engineering, Biology & Biochemistry, and Biomedical Engineering at the University of Houston, and a Senior Affiliate of The Houston Methodist Hospital Research Institute. He holds B.S. (honors) and M.S. degrees in Chemical Engineering from Caltech, and completed his Ph.D. and postdoctoral studies at MIT. Dr. Willson is former Chair of ACS BIOT, and an elected Fellow of the AIMBE, ACS, RSC, and AAAS. He is a member of the National Academy of Inventors, was CTO of Visigen which built the first system for single-molecule sequencing-by-synthesis, was on the founding Technical Advisory Board of Moderna from 2012, and served for a time as interim Associate VP for Technology Transfer of the University of Houston, then the non-medical public university with the largest patent royalty income in the US. His research interests are in PAT, and the purification of biological molecules.

Abstract
Continuous and high-intensity processing, rapid process development, and digitalization all benefit from continuous data. We have developed a fiber-optic probe that continuously reports Fc concentrations, and are working to make it CIP-compatible and usable both at very low concentrations (for breakthrough detection) and higher ranges (for g/L titer measurement. Separately, we have adapted lateral-flow immunoassays (the format of many COVID-19 tests and the home pregnancy test) to rapid, local, determination of process and product characteristics.

Borna Ghosh

Associate Director, Downstream Process Development

Alexion

 

Borna Ghosh is an Associate Director in Downstream Process Development at Alexion, AstraZeneca Rare Disease, with over nine years of industry experience. She holds a Ph.D. in Biophysics and has previously contributed to biologics development at Merck & Co, BMS and Eli Lilly. She specializes in Process Characterization, Viral Clearance, and commercial scale up, applying QbD to build robust control strategies, drive PPQ readiness, and enable efficient tech transfer.

 

Jack Prior

PhD, Head, Process Monitoring & Data Science & AI Strategy

Sanofi Group

Jack Prior, Sc.D., is Head of MSAT Process Monitoring & Data Science/AI Strategy at Sanofi, where he leads initiatives at the intersection of bioprocess manufacturing science, advanced analytics, and AI implementation across a global biologics manufacturing network. Over nearly three decades with Sanofi (formerly Genzyme), he has driven operational impact in yield improvement and process performance, and has been recognized with three Sanofi Global Innovation Awards.

His work spans process troubleshooting, continued process verification, technology transfer, and digital transformation, with a particular focus on building the data foundations that enable AI to deliver value in biologics manufacturing. He developed the BioMetre framework as a practical maturity model for assessing manufacturing process data readiness.

He serves on the PDA Science Advisory Board as an AI expert and on the MIT Leaders for Global Operations Governing Board. He holds a Doctor of Science in Chemical Engineering from MIT and a B.S. from the University of Connecticut.

Abstract

Despite widespread digital transformation, biopharmaceutical manufacturers leverage only a fraction of the process data they generate. The barriers are not purely technical — conflicting stakeholder priorities, compliance-first cultures, and siloed expertise are equally limiting.
This presentation introduces a practical maturity model and balanced scorecard framework tested across a global biologics manufacturing network. The model assesses readiness across two dimensions: what data is delivered (CQAs, yields, batch, continuous, genealogy, extracted features) and how (freshness, accessibility, structure, scalability). A five-level scoring rubric enables objective, quantitative comparison across products and sites. Application across 25+ products reveals maturity scores of 30–80% (median ~55%), with most sites strong on foundational metrics but falling short of advanced analytics readiness.

Take-Home Message:

Digitization is necessary but not sufficient. Organizations must objectively assess and systematically improve data quality, accessibility, and structure before AI and process monitoring can deliver value. This framework provides the GPS.

 

Rui Wheaton

Principal Process Engineer

Bristol Myers Squibb

Rui Wheaton is currently a principal scientist in the Digital Strategy and Process Optimization group at Bristol Myers Squibb. Her focus is advanced computational models and digital twins in manufacturing and process development. Prior to her current role, she has experience as a senior scientist in the Process Modeling and Data Scientist group at resilience and Process Engineer in the Manufacturing Technology Upstream group at Bristol Myers Squibb. Rui holds a Ph.D. in Chemical Engineering from Worcester Polytechnic Institute.

Abstract

Last year’s presentation introduced a model?based approach for real?time predictions of cell culture dynamics and critical quality attributes (CQAs), enabling SMEs to make data?informed decisions to optimize process control and improve product yield and consistency. This year, we highlight a key challenge observed in practice: reduced prediction performance for atypical batches, where a harvest?timing CQA undergoes a rapid crash late in culture.
We first quantified the crash behaviour to define a consistent modelling target, then examined the role of integrated VCD and other features in identifying early signals of decline. These insights supported new models that predict the onset of the crash event and guided enhancements to the original real?time prediction algorithm to improve CQA forecasts within the crash region.
These updates strengthen model robustness across both typical and atypical trajectories, supporting more reliable harvest?timing decisions.

 

Sri Madabhushi

Senior Director

AstraZeneca

Sri is a Senior Director at AstraZeneca, where she leads teams focused on cell culture process development and material supply. She has served as CMC lead across multiple early- and late-stage programs, shaping timelines and strategy, orchestrating stakeholder management, and delivering end-to-end outcomes spanning drug substance, drug product, clinical supply, and regulatory submissions. As a recognized scientific leader, she defines the strategic roadmap for scientific and technology investments and has advanced next?generation innovations, including ultra?productive fed?batch processes (>20 g/L), process intensification and continuous manufacturing, media development, and end?to?end platform design.

 

Terrence Dombrowsky

Senior Director

Takeda

Terrence Dobrowsky has been a group leader in Biotherapeutics Process Development at Takeda since 2023. His group focuses on establishing Process, Automation, and In Silico tools to advance process performance, control, and overall development for Biologics programs. Prior to joining Takeda he led the Gene Therapy Drug Substance Development group at Biogen. He has supported the development of multiple Biologics programs as well as novel production platforms through internal development as well as industry or academic collaborations. He has contributed to program and technical initiatives spanning early phase development, mid-phase optimization and late-phase process characterization. Terrence earned B.S. in Chemical Engineering from the University of Notre Dame and a Ph.D. in Chemical and Biomolecular Engineering from Johns Hopkins University in 2010 where he focused on characterizing viral adhesion kinetics.

 

Lye Lin Lock

Associate Scientific Director

Bristol Myers Squibb

Lye Lin Lock is an Associate Scientific Director in the Downstream Biologics Process Development at Bristol Myers Squibb (Devens, MA). She leads digitalization initiatives that connect instrument data to cloud databases, standardize data capture for chromatography and filtration, and surface insights through automated dashboards. At BioTalk 2026, Lye Lin will share how to build a contextualized data framework that links ELN/eBR records, process metadata, and analytics to accelerate decisions and improve knowledge continuity across sites and tech transfer. Outside of work, Lye Lin enjoys baking bread and traveling to different national parks.

 

Min-Cheol Kim

Process Engineer IV

Sanofi

Dr. Min-Cheol Kim is a Process Engineer at Sanofi. His current interest areas are building hybrid models by integrating machine learning and digital twin modelling on bioprocess engineering and computational fluid dynamics (CFD) single and multiphase fluid simulations on mixing tanks.

Abstract

Controlling of desired set-point of glucose concentration has gained great interest in the upstream bioprocess engineering. In addition, it is also crucial in maintaining the product quality and less lactate production. For example, it has been known that too excessive dextrose can lead to increased waste production, such as lactate and ammonia, which can significantly reduce viable cell density in a bioreactor.

However, real-time control of glucose is currently limited because glucose has been offline-measured, and too frequent offline or even at-line measurement has practical limitations and increases the risk of contamination. Here, we present a robust model-based process control (MbPC) strategy for the successful glucose feeding in a bioreactor using only daily offline measurements.

Our MbPC strategy is composed of two kinds of formulas for predicting 1) glucose feeding amounts at daily sample time-points and 2) glucose feeding amounts at unsampled time-points.

First, we used a detailed simulation of the cell culture to determine a theoretical optimal dextrose feeding strategy for a nominal cell culture. Then we determined a practical feeding strategy that can be implemented given equipment constraints. Then the second part of the strategy is to augment that nominal open-loop control strategy with daily dextrose additions based on a discrete-time proportional control strategy to responds the expected variation from the assumed nominal performance.

Finally, we successfully implemented our MbPC strategy to Ambr250 bioreactor experiments for the frequent glucose feeding.

 

Kheng Tee Ng

Senior Scientist

Abbvie

Dr Kheng Tee Ng currently works as a Senior Scientist at AbbVie Biologics Singapore where he works on purification process development (i.e. process internalization, simplification and intensification) and CMC related aspects (i.e. tech transfer, process characterization modeling, facility fit, risk assessment and investigations) of biological drug development. Prior to working with AbbVie, he was a process characterization scientist at Lonza where he has directed multiple process characterization studies such as scale down model building for different unit operations (chromatography, depth filtration and UF/DF), resin lifetime as well as DoE modeling experiments which supported the establishment of NOR/PAR process ranges in FMEA for different customers. Dr Ng has obtained his PhD from University of Cambridge in 2016 and BSc from University College London in 2012.

 

Irina Ramos

Director, Bioprocess Technology and Engineering

AstraZeneca

Irina Ramos is a director of downstream continuous manufacturing, in the Bioprocess Engineering and Technology group at AstraZeneca in Gaithersburg, MD, USA. She has been a key driver of the technology development and implementation strategy for continuous biomanufacturing. Her team works to increase fundamental understanding of various downstream unit operations of drug substance manufacturing. They manage the design, testing and qualification of process equipment and automation of the systems to integrate them.

Dr Ramos holds a BS/MS in Chemical Engineering from University of Porto (Portugal) and a PhD in Chemical & Biochemical Engineering from University of Maryland, Baltimore County (UMBC). For the past 14 years, Dr Ramos’ work in the pharmaceutical industry has spanned from early to late-stage process development and validation, process scalability, CMC and technology transfer to both clinical and commercial manufacturing. With that experience, Irina lead process transfer efforts of the AZ COVID-19 vaccine. She has been involved with NIIMBL Process Intensification program by leading the Control Strategy workstream since 2020 and has been teaching graduate level classes on a Biotechnology Master program since 2015.

 

Rajat Sharma

Staff Engineer, Biotherapeutics process development
Takeda

I am Rajat Sharma, Ph.D.
I am currently working as the tech-transfer lead for GMP tech-transfers for clinical biologics assets at Takeda, in Lexington, MA.
My academic research involved studying and developing microbial processes for generation of valuable bio-products from fibrous agricultural waste biomass. (MS in Biological and Agricultural Engineering, NCSU, Raleigh, NC,& Ph.D. Food Science and Technology, ISU, Ames, IA).
I started my industrial career at Valent Biosciences in 2017, as a Sr. Fermentation engineer, where I was responsible for end-to-end large-scale upstream bacterial cell cultures.
I joined Takeda in 2020, as a member of the Microbial development team, where I worked on process development and CMC activities for the microbiome and E. coli protein expression programs.
I later moved on to my current role as Tech-Transfer lead for clinical GMP biologics assets, where I am responsible for seamless process transfers from process development/pilot processes to clinical GMP scales for internal and external manufacturing receiving units.

Abstract

Tech-transfer landscape is complex with multiple programs, multiple modalities and a wide network of manufacturing partners (internal/CDMOs). In such an environment, its important to approach a tech-transfer which is inherently a complex activity, with constant pressure of timely completion and being right: “first time”. This presentation is a high-level showcasing of the tools and approaches that can be employed in this complicated TT landscape. The discussion in this presentation will be centered around the following themes: tech-transfer work flow & structure, dos and donts, network strategy, comprehensive process transfer templates, streamlining flow of information, tech-transfer communication strategy, digitalization, and seamless connectivity to electronic management systems in manufacturing.

Dr. Sarwat Khattak

Head of Cell Culture and Cell Line Development

Biogen

Dr. Sarwat Khattak has 15+ years of experience in the biopharmaceutical industry and has been with Biogen since 2016. She is the Head of Cell Culture Development and Cell Line Development Biologics. Sarwat received her Ph.D. in Chemical Engineering from University of Massachusetts at Amherst and her B.S. in Chemical Engineering from MIT. She has extensive experience in recombinant protein program development through commercialization, cell culture media design, modelling cell culture processes, product quality optimization and continuous manufacturing.

 

 

 

Manoj Ganesh

Sr. Staff Process Scientist

Regeneron Pharmaceuticals

• PhD Materials Chemistry from NYU Tandon School of Engineering (2012)
• Joined Regeneron in 2018 - 5 years of BioPharmaceutical Downstream processing and Investigations
• Leads a Team of 10 People involved in Highthroughput Automation and Analytics
• Research experience in the field of Automation of downstream applications, Protein purification, Filtration, Polymer Chemistry, Biodegradable Polymer, Enzyme Immobilization & Bio-catalysis
• Publications include 7 journal articles, 1 book chapter and 1 patent awarded.

Fun Fact
• Prior to Regeneron, Manoj has 5 years of proactive startup skill experience in the biobased chemical industry
• Enjoys cycling.

 

Tom Ransohoff

Operating Partner, Keensight Capital, Principal, RTI Consulting

Keensight Capital

Thomas Ransohoff, M.S., has over 35 years of experience in the biopharmaceutical industry with broad experience in the development and manufacture of biologics and in the management of technology-based start-up firms. He is currently Principal, RTI Consulting, LLC, providing strategic and advisory consulting services to life sciences firms, and an Operating Partner with Keensight Capital. Previously, Mr. Ransohoff was Technical Head, Biologics Franchise for National Resilience, Inc. who he joined through the acquisition of 4th Dimension Bioprocess, where he was a co-founder and COO. Before joining Resilience, Mr. Ransohoff was a Managing Director at BDO and its precursor BioProcess Technology Consultants (BPTC), a leading CMC consulting firm that he helped build over a 20 year period. Prior to that, he held senior level positions at TranXenoGen, Dyax, Repligen, and Xoma. Mr. Ransohoff is a co-founder of several successful start-ups, including 4th Dimension Bioprocess, Tarpon Biosystems and BioFlash Partners, and he holds several board and scientific advisory board appointments. He holds a Bachelor's degree from MIT and a Master's degree from the University of California, Berkeley, both in Chemical Engineering.

 

Ishaan Shandil

Director, MS&T Process Modeling and Analytical Technologies
Bristol-Myers Squibb

 

Ishaan Shandil is a Biochemical Engineer with 16 years of process and product development, manufacturing and project leadership experience in the Biopharmaceutical industry. Ishaan currently works as an Associate Director Process Engineering MSAT Bristol-Myers Squibb (BMS) where he is responsible for leading projects in Process Engineering and Manufacturing Technology functions. In his role at BMS, he also manages the technical aspects of an external manufacturing relationship and provides CMO oversight. Prior to joining BMS, Ishaan worked for Merck & Co. in roles spanning across R&D and Manufacturing where he designed and developed scalable bioprocesses to manufacture differentiated biologics drug candidates. He also studied and published the impact of process conditions on Glycosylation in monoclonal antibodies and fusion proteins. Ishaan received a MS in Chemical & Biochemical Engineering from University of California Irvine and an MBA from University of Chicago Booth School of Business.

Henry Lin

Global Head, Cell Culture Process Development
Sanofi

Henry Lin is a 20+ years veteran in the biopharma industry with deep subject matter expertise in the upstream space as well broad CMC experience spanning pre-clinical to FIH to commercial. He is currently the Global Head of Cell Culture Process Development at Sanofi having responsibilities for all of upstream development in U.S. and France. Prior to Sanofi, Henry was an Executive Director in Biologics Process Development at Merck, Director of Cell Culture Development at Boehringer Ingelheim, and Principal Scientist at Amgen. Henry is a co-inventor on 10 patents and an author of 28 peer-reviewed publications. Henry received his PhD in biochemical engineering from Rice University and bachelor’s degree in bioengineering from UC San Diego.

Ionela Iliescu

Sr. Scientist
Amgen

Process Development Scientist at Biogen for 26 years. Coordinate purification development activities for antibodies, fusion proteins, and other types of biological therapeutics. Lead for purification strategy, process development for internal and external programs, process characterization, process validation activities and related global regulatory filings.

Spencer Monaco

Sr. Associate Scientist
Biogen

Spencer is an NCSU graduate with a B.S. in Polymer and Color Chemistry. His first job was working on the Biogen manufacturing floor alternating between upstream and downstream activities, until migrating into a development support role and expressing interest in upstream media development. He currently works with the cell culture development teams at Biogen, providing chemical expertise to investigations and new media formulation construction. As of 2024, Spencer has returned to NCSU to pursue a Masters in Polymer Chemistry exploring the possibility of bringing advances in polymer science into the media design space.

Abstract

Large scale media production presents various challenges to modern bio-pharmaceutical companies. Highly concentrated feed solutions must be constructed with extra care to ensure the solution remains viable throughout a campaign. A 5L small-scale model was designed to capture comparative mixing stress, temperature profiles, and exposure times to reliably replicate precipitation seen during a production run. The data from the scale down model was used to redesign the formulation and process parameters to produce a stable solution at all scales. In addition to automation parameters, floor operations were evaluated for gains in operational efficiency. Implementation of the observed process changes resulted in successful subsequent media preparation and confirmation of the scalable design.

Matthias Wiendahl

Principal Scientist
Novo Nordisk A/S

- Diploma in Biotechnology at Technical University Braunschweig, Germany
- PhD (Dr. Ing.) in Juergen Hubbuchs group at Research Center in Juelich, Germany
- 2007-2012: Development scientist at Novo Nordisk A/S, Denmark
- > 2012: Principal Scientist in Manufacturing Science and Technology department at Novo Nordisk Denmark

Abstract

Continuous capture chromatography is a chromatographic technique promising higher resin utilization, higher productivity and lower buffer consumption than traditional batch chromatography capture processes. The design of cSMB processes is more challenging than the design of batch processes because each chromatographic phase is influenced by the load from the previous phase and it is in turn influencing the subsequent phase. An iterative approach can be used to identify optimal conditions.

Our current process design approach is based on single column breakthrough curves and feeding the breakthrough data into a model. However, this concept leads to a sub-optimal process as it is based on a single loading flow rate, while effectively, flow rates and amounts in interconnected and parallel load phases can be different so using one flow rate only leads to sub-optimal processes.

We are presenting an approach where different flow rates and different breakthrough curves are used as model inputs together with pressure-flow dependencies for the resin of interest. Using the improved process design, significantly higher productivities were achieved than with the standard procedure. The effect was confirmed for a given in-house model process (mAb purification using Protein A affinity chromatography) where productivities could be increased by approximately 50% which has been confirmed at laboratory scale. The presented approach was also evaluated using mechanistic modelling. Finally, implications of the new cSMB design approach for large-scale manufacturing are discussed.  

Dr. Wenqin Ni

Senior Principal Scientist
Pfizer

I joined Pfizer in 2013. Currently, I am a Senior Principal Scientist in Pfizer and lead multiple analytical programs from early stage (before clinical study) to commercial approval. My expertise is focusing on analytical strategies such as process characterization and comparability studies. I successfully developed comparability strategies for multiple programs to support clinical or commercial material usage after manufacturing process changes. In addition, I am a key lead/member of analytical comparability expert group in Pfizer to review analytical comparability strategy for biologics. Before joining Pfizer, I received a Ph.D degree in Northeastern University focusing on characterization of post-translational modifications in biologics using LC/MS.

Abstract

During product development and the life cycle of commercial product, process changes are inevitable. Products manufactured using pre- and post- process changes are required to demonstrate comparability per ICH Q5E. A comparability study is a critical tool to ensure the “similarity” of product quality including efficacy, pharmacokinetics, safety and immunogenicity.
In this presentation, a phase appropriate risk assessment of process change will be introduced, followed by comparability strategy based on the risk assessment. Analytical comparability study tools will be discussed including the analytical comparability plan, comparability criteria, execution, data analysis and presentation. Furthermore, non-clinical and clinical comparability will be briefly discussed if there is any analytical difference which may impact product quality. Two comparability case studies will be presented. The first study is to support a new bioprocess to improve product quality and to facilitate larger scale manufacturing. The second one is to support the use of an early process stability study for establishing commercial shelf-life by leveraging the comparability study for an accelerated program. The agency feedback from multiple markets for the case studies will also be discussed.  

Kyle McHugh

Associate Director
Takeda Pharmaceuticals

Kyle McHugh received his PhD in Chemical and Biological Engineering from the University of Delaware on cell culture models of neurodegenerative disease. He worked in Upstream Biologics Process Development at Bristol Myers Squibb supporting commercial process development and process characterization for multiple therapeutic protein projects as well as high-throughput optimization, media development, and PAT advancement. Currently, Kyle is an Associate Director of Biotherapeutics Process Development at Takeda Pharmaceuticals in Lexington, MA supporting advancement of platform capabilities and multiple project modalities from FIH through late-stage development.

Abstract

Speed to clinic is critical to enable faster identification of successful early-stage drugs and subsequently faster BLA filing to commercialization. Here we discuss multiple levers to enable faster timelines to IND balancing prioritization of the timeline, business risk, and minimization of pre-investment. From a cell line perspective, strategic choice of source material for exploratory and GLP Tox studies allows for earlier delivery of representative material. Application of automation tools for screening clones and sampling bioreactors allows for more extensive screening and efficient process development. Data connectivity for automated capture and visualization of real-time offline and online process metrics helps to monitor ongoing runs, aggregate data for modelling, and streamline analysis for reports and regulatory submissions. Overall, we demonstrate significant improvements in speed, throughput, and automation for early-stage cell culture process development.

Angela Lewandowski

Sr. Director | GDPE (Global Downstream Dev/Pilot Plant/External Mfg)
Bristol Myers Squibb

Angela joined Bristol Myers Squibb in 2013, and over time has taken on increasing responsibilities. Angela and her team of 4 direct reports and 16 full-time employees are responsible for downstream process development for BMS’ growing biologics pipeline. Angela is currently doing a 6-month rotation, where she leads an additional team of 4 direct reports and 28 full-time employees responsible for process analytics. She has been the drug substance matrix lead since 2016 for a monoclonal antibody asset, from mid-stage through commercialization and life cycle management. She has driven several key strategic cross-functional initiatives. Prior to BMS, she worked for several years at Sanofi Genzyme and Regeneron Pharmaceuticals, and has a total of over 19 years of industrial experience. Angela holds M.S. and Ph.D. degrees in Chemical and Biomolecular Engineering from the University of Maryland, and a B.S. in Chemical Engineering from the University of Virginia.

Scott H. Altern

Senior Scientist
AbbVie

Scott H. Altern completed his PhD in Chemical Engineering at Rensselaer Polytechnic Institute (RPI) in Professor Steven Cramer's group (2023). His PhD research was centered on advancing the state-of-the-art in mechanistic modeling of preparative column chromatography and high-throughput process development. Currently, his role is at AbbVie in Worcester, MA where he focuses on mechanistic modeling of preparative chromatography, computational fluid dynamics, and molecular modeling to directly aid in process development. Scott is also highly involved in using high-throughput (HT) experimentation to expedite process development and model generation. Overall, Scott aims to transform industrial bioprocess development using automation and multiscale modeling.

Abstract

In this work, we employed HT instrumentation and multiscale modeling to support early-stage process development for two monoclonal antibodies (mAbs). These molecules had nearly the same isoelectric point but were found to behave differently in CEX. Both antibodies were screened for their dynamic binding capacity (DBC) on POROS XS RoboColumns across a wide range of loading pH and conductivity. Curiously, opposing DBC trends with loading pH and conductivity were observed between the mAbs. Generally, increasing loading pH and conductivity, beyond a certain threshold, results in a reduced DBC in CEX systems. This was consistent with the behavior for mAb B, but contradicted the trends seen for mAb A. Molecular modeling was then employed to identify the molecular features responsible for the unusual screening results. Homology models were constructed for each of the antibodies, from which molecular descriptors were calculated. Descriptors such as net charge and CDR positive charge surface area were correlated with DBC values to confirm that the degree of exclusion was directly related to molecular charge properties. Additionally, mechanistic model parameters were regressed from RoboColumn breakthrough curves to provide additional insight into the unique chromatographic behavior. For instance, trends in surface diffusivity with loading conductivity and pH were examined to determine their contribution to CEX loading performance. Further experimental studies were conducted in order to elucidate the molecular origins of the observed trends. Dynamic light scattering (DLS) experiments were carried out to determine the protein-protein interaction constant over a range of pH and conductivity. Interaction strength was found to be correlated with DBC, suggesting that repulsive forces negatively affect DBC and are dependent on solution conditions. In summary, this study used high-throughput screening and multiscale modeling in conjunction to facilitate CEX PD and improve process understanding from a molecular perspective. 

Daryl Powers, Ph.D.

Director, Bioprocess Technology Manufacturing, Science and Technology
Bristol Myers Squibb

Daryl is a director in the Bristol Myers Squibb MS&T drug substance group. He leads a team of process subject matter experts and laboratory scientists supporting the BMS commercial and registrational biologics portfolio. He has a PhD in chemical engineering and 18 years experience in the biotechnology industry.
 
Abstract
A commercial process was experiencing significant yield and product quality variability. To enhance process SME insights, the enterprise invested in a substantial modelling effort, which included building a data pipeline and conducting both non-proprietary and proprietary process modelling efforts. Initial observations confirmed SME insights and provided quantified targets for future batches. The work for this project highlighted opportunities to improve data quality through addition of PAT tools, expanded data sources, and incorporation of more mechanistic features into models.

Dhanuka Wasalathanthri

Associate Director
Bristol Myers Squibb

Dhanuka Wasalathanthri, Ph.D. is an Associate Director at Bristol Myers Squibb (BMS) where his main role is to serve as the strategy lead for Process Analytical Technology (PAT), High-Throughput Automation and Digital Capabilities at Analytical Development organization. He is a versatile leader with more than 10 years of biotech industry experience in strategic implementation of technologies, CMC analytical development, project management and building high-performing teams in meeting corporate goals. Dhanuka represents BMS at several academic and industry consortia, and he Holds a Ph.D. in Analytical Chemistry from University of Connecticut, USA.

Abstract

Biopharmaceutical landscape is getting increasing complex with a broad spectrum of modalities to meet unmet medical needs, while external geo-political, regulatory, generic competition and sustainability challenges demand acceleration of drug development pipelines. Despite significant advancements in the development and manufacturing workflows for faster and more efficient processes such as intensified and continuous operations, in-process analytical testing is still mainly centric around manual testing. Harnessing the power of automation enables fit-for-purpose and plug-and-play modular units with end-to-end parallel testing of multiple analytical assays with significant improvement in speed and productivity. The concept of robotic process automation (RPA) tools resembles as “Digital Workers” to automatically process, analyze and transcribe analytical results in real time which greatly improves the rapid availability of data to the stakeholders. Complex modalities in the pipeline often require non-platform analytical methods, unique approaches, and upfront investment on method development. Such efforts can be greatly simplified using data interrogation techniques such as Machine Learning and Deep Learning approaches. Herein a vision, roadmap and case studies of automation and digital transformation efforts measured against main KPI’s such as speed and productivity for in-process analytics for biologics are presented.

Shyam Panjwani

Principal Data Scientist
Bayer Pharmaceuticals

Shyam Panjwani is currently working as a Principal Data Scientist at Bayer Pharmaceuticals, Berkeley. He holds a PhD degree from University of Houston and a bachelor’s degree from Indian Institute of Technology, Kanpur in chemical engineering. He has 8+ of experience in applying AI/ML/statistics for biologics manufacturing processes, biological assays and process development. Before joining Bayer, he worked with Halliburton and Air Products.

Abstract

The biopharmaceutical industry is increasingly turning to data science to optimize manufacturing processes and enhance product quality. This presentation explores two innovative case studies that leverage data science to improve efficiency in biologics manufacturing.

The first case study focuses on a cloud-based predictive modeling application designed to enhance the predictability of mammalian cell culture processes. By forecasting bioreactor potency from at-line process parameters over a multiple-day horizon, this application quantifies prediction uncertainty and provides valuable insights for process control, ultimately enhancing productivity and product quality.

The second case study presents a novel framework for assessing the out-of-specification (OOS) risk associated with drug product potency. This framework utilizes a cloud-based statistical software application to streamline the evaluation of alternate potency targets, reducing manual errors and improving the efficiency of risk assessments.

Together, these case studies illustrate the transformative impact of data science on the biopharmaceutical manufacturing landscape. 

Sandra Bennun

Director Biologics Process Development, BPR&D
Merck

Experienced R&D Director with a demonstrated history of evaluating and delivering Process Analytics and Automation solutions to clinical and commercial biologics manufacturing.

Carrie has been with Lonza for 17 years. Her focus at Lonza includes commercial biomanufacturing SME support and technology transfer of clinical to commercial manufacturing. She has been a key contributor to the Lonza R&D efforts in intensified, continuous mAb manufacturing. Her current role is leading a multidisciplinary team in the investigation and development of novel bioprocessing modalities with a focus on process analytical technologies. Recently she was in charge of the design and build of a stand alone state of the art facility for the research of novel technology and automation. The Process Innovation Center was completed in March 2024. As the Head of the PIC, Carrie is responsible for directing PAT and Automation research, Industry and Academic collaborations in the New England Biotech Ecosystem.

She has over 25 years in industry primarily focused on development of chromatography and separations technology with associated analytical method development. She is a member of numerous industry consortia and collaborative efforts with the intent to drive forward innovations to advance the current biomanufacturing processes.

 

Carrie Mason 

Associate Director Bioprocess R&D
Lonza

Experienced R&D Director with a demonstrated history of evaluating and delivering Process Analytics and Automation solutions to clinical and commercial biologics manufacturing.

Carrie has been with Lonza for 17 years. Her focus at Lonza includes commercial biomanufacturing SME support and technology transfer of clinical to commercial manufacturing. She has been a key contributor to the Lonza R&D efforts in intensified, continuous mAb manufacturing. Her current role is leading a multidisciplinary team in the investigation and development of novel bioprocessing modalities with a focus on process analytical technologies. Recently she was in charge of the design and build of a stand alone state of the art facility for the research of novel technology and automation. The Process Innovation Center was completed in March 2024. As the Head of the PIC, Carrie is responsible for directing PAT and Automation research, Industry and Academic collaborations in the New England Biotech Ecosystem.

She has over 25 years in industry primarily focused on development of chromatography and separations technology with associated analytical method development. She is a member of numerous industry consortia and collaborative efforts with the intent to drive forward innovations to advance the current biomanufacturing processes.

 

Shuangping Shi

Associate Vice President, Head of Biologics Process Research & Development
Merck

Experienced pharma leader with extensive knowledge in biologics CMC, small molecule CMC, commercial manufacturing, bioanalytics, GLP lab management and GMP manufacturing facility operation.

 

Brandon Moore

Senior Cell Culture Engineer II
Biogen

Brandon Moore is an Upstream Process Engineer with 13 years of experience working on the development, characterization, and optimization of mammalian cell culture biomanufacturing processes with a specific focus on advanced process control and process analytics. Throughout this work, a recurring theme that has surfaced is the need for new approaches towards improving process understanding using advanced modelling and troubleshooting techniques which take the unique complexities and performance of cell-based systems into account.

Abstract

Variability was observed in the cell culture performance of inoculum stages in batches of a large-scale HEK293 commercial therapeutic protein production process. The impact was significant enough in result in termination of several batches, as insufficient cell mass was present to inoculate subsequent stages. Root cause analysis and bench-scale laboratory studies indicated that the large-scale media preparations were the root cause of the growth impact, and that the magnitude of impact varied between media bottles within a batch. Additionally, variability was observed between multiple batches of media which used identical filtration and preparation operations.

The investigation summarized in this case study examined each step of the media preparation and filtration processes. Bottle-to-bottle variability in media performance was replicated under laboratory conditions when using a specific 0.1µm polyethersulfone (PES) pre-filter which was part of the filtration platform for Chinese hamster ovary (CHO) processes. Interestingly, the first few bottles of media filtered were found to support normal growth—performance impact was first observed in later bottles, becoming more severe before eventually resolving. This behavior is inconsistent with the widely-held assumption that the magnitude of process impact would be greatest in the first volume of media passing through a filter. Replacing the filter was found to result in restoration of consistently high cell growth in the previously-impacted inoculum stages. This case study highlights the importance of the robust evaluation of filtration schemes between media formulations for different cell lines and the strategic application of platform process elements.

Alexandre Super

Lead Statistician CMC Development
UCB

Alexandre currently works within the Centre of Expertise CMC Statistics at UCB Pharma. He is responsible the development and implementation of statistical and modelling approaches for biologics and medical devices projects throughout their lifecycle, from the early stages of technical development all the way to commercial manufacturing.

Yiannis Dres

Process Engineer, Clinical Manufacturing
Pfizer

Alessandra Molinaro is a Process Engineer with six years of experience in the biopharmaceutical industry specializing in cell culture operations at the clinical scale. Alessandra has a Bachelor of Science in purification at the clinical-scale and GMP Manufacturing. Yianni has a Bachelor of Science in Chemical Engineering from University of Massachusetts Lowell and a Master of Science in Biotechnology from Worcester Polytechnic Institute.

Abstract

Implementation of a new technology in a GMP manufacturing environment present several distinct challenges, including adhering to regulatory requirements, implementing new methods into the existing systems, as well as management of new risks. In this work, we present a case study of the implementation of the One-Pot Capture Redox (OPCR), a novel technology for the production of multispecifics, into a clinical production facility.

This presentation will discuss the challenges of introducing the OPCR technology at the clinical manufacturing scale. Based on the success of implementation of the new technology, a harmonized approach has been identified to enable other new technologies to be implemented simpler in GMP manufacturing.

Alessandra Molinaro

Process Engineer, Clinical Manufacturing
Pfizer

Alessandra Molinaro is a Process Engineer with six years of experience in the biopharmaceutical industry specializing in cell culture operations at the clinical scale. Alessandra has a Bachelor of Science in Chemical Engineering from the University of Massachusetts Lowell and a Master of Science in Biotechnology from Worcester Polytechnic Institute.

Abstract

Implementation of a new technology in a GMP manufacturing environment present several distinct challenges, including adhering to regulatory requirements, implementing new methods into the existing systems, as well as management of new risks. In this work, we present a case study of the implementation of the One-Pot Capture Redox (OPCR), a novel technology for the production of multispecifics, into a clinical production facility.

This presentation will discuss the challenges of introducing the OPCR technology at the clinical manufacturing scale. Based on the success of implementation of the new technology, a harmonized approach has been identified to enable other new technologies to be implemented simpler in GMP manufacturing.

Jian Ren

Principal Scientist, Bioprocess Development
Abbvie

Jian Ren is a Principal Scientist in the Manufacturing Science and Technology (MSAT) organization at AbbVie Bioresearch Center in Worcester, MA. She leads process tech transfer, validation, and manufacturing support activities for the downstream manufacturing process for late phase and commercial biologics programs, including monoclonal antibodies, bispecific antibodies and fusion proteins. Prior to MSAT, she led purification process development, tech transfer, and validation activities for early-to-late-phase biologics projects. Prior to AbbVie, her research focused on the development and optimization of polymeric membranes and modules for various separation applications. Jian holds a PhD in Chemical Engineering from the University of Connecticut.

Lihua Yang

Senior Principal Research Scientist
Abbvie

Dr. Lihua Yang has been at AbbVie for over 20 years and is currently a Senior Principal Research Scientist and Group Leader within the Purification Development Department in Product Development Science and Technology organization. Dr. Yang led 25+ early and late phase programs and numerous innovation initiatives on biologics in areas of mAb, bispecific, antibody-drug conjugates and gene therapy. She has extensive experience in bioprocess development, characterization, validation, tech transfer to global GMP manufacture, process internalization, product launch, IND and BLA filing. Besides leading strong functional and cross-functional teams to deliver innovative and improved purification process, Dr. Yang is also a subject matter expert in bioanalytical assay development and protein characterization. Dr. Yang holds a Ph.D degree in Chemistry and Chemical Biology from Northeastern University, and a BS degree in Physical Chemistry from Peking University in China.

Tom Ransohoff

OPERATING PARTNER
Keensight Capital

With over 35 years of professional experience in the biopharma industry, his experience includes serving as the Technical Head of the biologicals franchise within Resilience, overseeing all activities related to recombinant protein and monoclonal antibody projects and technology development initiatives.

Prior to that, Tom has held various C-suite positions at other biopharma companies such as 4th Dimension Bioprocess, Inc. (co-founder and COO), BioFlash Partners (President and CEO), TranXenGen, Inc. (Vice President, Operations), Dyax Corp (Vice President, Program Management and Product Development).

Tom is a regular speaker at leading biopharma conferences, has published over 20 academic articles and has also developed and filed several patents, related to innovative biopharma manufacturing processes.

Tom holds a B.S in Chemical Engineering from MIT and a M.S. in Chemical Engineering from the University of California, Berkeley.

Ishaan Shandil

Director, MS&T Process Modeling and Analytical Technologies
Bristol Myers Squibb

Ishaan Shandil is a Biochemical Engineer with 16 years of process and product development, manufacturing and project leadership experience in the Biopharmaceutical industry. Ishaan currently works as an Associate Director Process Engineering MSAT Bristol-Myers Squibb (BMS) where he is responsible for leading projects in Process Engineering and Manufacturing Technology functions. In his role at BMS, he also manages the technical aspects of an external manufacturing relationship and provides CMO oversight. Prior to joining BMS, Ishaan worked for Merck & Co. in roles spanning across R&D and Manufacturing where he designed and developed scalable bioprocesses to manufacture differentiated biologics drug candidates. He also studied and published the impact of process conditions on Glycosylation in monoclonal antibodies and fusion proteins. Ishaan received a MS in Chemical & Biochemical Engineering from University of California Irvine and an MBA from University of Chicago Booth School of Business.

Ravi Vattepu

Senior Scientist Pivotal Biologics Drug Substance Technologies
Amgen

Ravi Vattepu is a Senior Scientist in the Pivotal Biologics Process Development group, focused on purification process development of biologics. He holds a PhD in Chemistry from Wichita State University and completed postdoctoral research at Harvard Medical School, where his work focused on antibody glycosylation and the role of IgG subclasses in inflammation.