DAY ONE

07.45 – 08.30

Registration

08.30 – 08.40

Welcome & Chairman’s Opening Remarks for Day One

08.40 – 09.10

Technology Innovations to Expedite Global Biologics Development

  • State-of-the-art technology platforms have been established to expedite global biologics development from discovery to commercialization.
  • Technology innovations will be highlighted for improving development efficiencies and reducing timelines from DNA to IND from a typical duration of 18 months to 7-9 months.

Federico Pollano, Senior Vice President, Rentschler Biopharma Inc

Downstream Processing

Upstream Processing

Chaired by Ravali Raju Principal Scientist, Pfizer

09.15 – 09.50

Pushing the continuous boundary beyond capture for implementation in clinical and commercial processes for portfolio projects

  • An Integrated Bioprocess for Continuous Processing at Late Stage, and Commercial
  • Opportunities for Facility and Process Intensification Beyond Perfusion Production and Continuous Capture
  • Different hand-shake scenarios between upstream and downstream operational modes to handle high titers and / or high harvest volumes
  • Continuous Virus Inactivation

Chad Varner, Scientist – Biologics Downstream Process Development, Sanofi

09.50 – 10.25

Downstream FIH Process Development for Non-Platform Molecules

  • FIH platform downstream process to fit F2FIH timeline
  • Key challenges for FIH drug substance process development
  • Downstream process development on non-platform molecules
  • Case study
  • Moving forward

Yan Chen, Associate Director, Downstream Bio-Process Development Bristol-Myers Squibb

09.15 – 09.50

Leveraging High Throughput Process Development for Microbial Systems

  • A variety of strategies for leveraging HTPD
  • Deep Exploration of Experimental Space
  • Rapid Process Characterization
  • Interfacing with Tech Transfer and Manufacturing

Mitchell Tai, Principal Scientist, Bristol-Myers Squibb

09.50 – 10.25

Utilization of computational fluid dynamics (CFD) to guide scale up/down of cell culture bioprocesses

  • CFD allows for a first principle numerical analysis approach to scale-up and transfer bioprocesses
  • Single-phase simulations were performed on BI Fremont bioreactors and media mixing vessels at different scales to estimate power number at different agitation speeds (P/V)

    • Consistent power number in the turbulent regime was demonstrated
    • Scale-down models were developed and verified through experimental and CFD results.
  • The CFD power numbers have been implemented at BIFI to calculate P/V in order to provide more accurate prediction for scale-up and transfer for BIFI bioprocesses

Dominique T. Monteil, PhD., Senior Scientist II, Cell Culture, Process Science, Boehringer Ingelheim

10.25 – 11.10

COFFEE BREAK & MEETINGS

11.10 – 11.40

Late stage cell culture and leveraging platform knowledge

  • In phase III cell culture, scientists must consider ways to optimize cell-culture conditions while maintaining productivity, quality and consistency
  • In addition to optimization, one must consider how to maintain these attributes when scaling-up, scaling-down and in tech transfer
  • In this presentation, we will outline the hurdles scientists may face in late stage cell culture and how automation platforms can help navigate these challenges

11.40 – 12.40

One to One Meetings

  • Downstream/Upstream Process Technology Platforms
  • Specialised cell culture media
  • Single-use & Disposable Technologies
  • Smart Manufacturing Technologies – Technology Transfer
  • Facility Management & Integration
  • Capacity & Facility Design
  • Multi product facilities
  • Energy & Operational Efficiency
  • Lean/Transformational Change – Operational Excellence
  • Continuous Improvement / Manufacturing Processing
  • PAT & MES, Automation and Process Control Excellence
  • QbD
  • Quality Assurance & Quality Systems
  • Regulation – Rapid Release Testing
  • Finance / Inward & Foreign Investment
  • cGMP – Contract, External Manufacturing Services
  • Biogenerics/Biobetters
  • Personalised Medicines
  • Cell & Gene Therapy
  • Fill and finish
  • Cold chain
  • Microbial Process Development and Production

11.40 – 12.10
The Evolution of Bioprocess Filtration Single Use Automation: From the Laboratory Bench to the Final Package

  • Why automating a single use bioprocess leads to increased process efficiency and reduces risks.
  • Overview of Parker Hannifin-the worlds leading motion and control company- and our offering in single use automation for bioprocessing applications.
  • How small-scale automation can be used to ensure scale up accuracy and filter performance at cGMP level.
  • The Parker SciLog FD- Automating bulk filtration and dispensing applications. The strategic benefits of automating this process.
  • Parker SciLog Automated NFF Systems – optimise, control and simplify NFF processes.

12.10 – 12.40
Fibro chromatography: Ultrafast purification platform addressing mAb purification bottlenecks

  • First truly Single-use Protein A capture chromatography technology
  • Case study data of Pilot scale purification
  • Process scale opportunities available in the near future explored

12.40 – 13.30

NETWORKING LUNCH

Downstream Processing

Chaired by Natraj Ram, Senior Director, Biologics Process Development, Alkermes

13.30 – 14.05

Simulation Tools in Biotechnology

  • Implementation of modelling and simulation tools in biotechnology
  • Mechanistic vs. statistic modelling
  • First steps towards an “Insilico Process Development”
  • Examples of the biotech industry (e.g. Chromatography Modelling)

Dr. Peter Schwan, Senior Expert Downstream , BayerTechnologies

Upstream Processing

Chaired by Ishaan Shandil Senior Engineer,
Process Engineering and MT External MFG, Bristol-Myers Squibb

13.30 – 14.05

Considerations in developing replacement media for legacy media and demonstrating comparable process performance or product quality

  • MVDA
  • Chemically-defined media development
  • Cell culture process development
  • Biologics production

Wai Lam Ling, Sr. Principal Scientist/Group Director, Merck & Co.

14.05 – 14.40

Enabling accelerated downstream process development for diverse protein therapeutics

  • Overview of process development challenges for a diverse product portfolio (mAb, bispecific, ADC, fusion, fragment, etc)
  • Strategies & case studies for accelerating purification development
    • Advancing manufacturing platform and toolbox
    • High throughput process development
    • Leverage platform/prior knowledge
    • Workflow improvement

Chen Wang, Director of Purification Development, Process Sciences, Abbvie

14.05 – 14.40

Novel and Innovative Characterization Methodology to Optimize Scale Up Strategies for Bioreactors

  • Oxygen Transfer Rate
  • Improving the Standard Measuring Method
  • Reactor Scale Up/Down
  • Optimizing Cell Culture Processes

Vivek Bhatnagar, Director Biopharm R&D, Teva Pharm

14.40 – 15.15

Digitalization from Past to Future – Process Development and Tech Transfer

  • Use of in silico plant model to guide process definition and linkage of process parameters to quality and performance attributes
  • Evolution of predictive model database and use of retrospective data to design prospective studies to enhance predictability
  • Potential to scale-up with data lake
  • Use cases with complex molecules

John Mattila, Director Purification Process Development, Regeneron

14.40 – 15.15

Building A Strong Upstream Manufacturing Platform: Leveraging Media Selection and Development

  • Introduction demonstrating the importance of establishing a strong upstream platform
  • General strategies to build a platform process transferable to GMP and commercial setting
  • Case study: Media second sourcing to ensure material supply
  • Case study: media development to simplify platform and support different modalities

Ting Guo, Ph.D., Scientist, Amgen

15.15 – 16.05

COFFEE BREAK & MEETINGS

16.05 – 17.35

One to One Meetings

  • Downstream/Upstream Process Technology Platforms
  • Specialised cell culture media
  • Single-use & Disposable Technologies
  • Smart Manufacturing Technologies – Technology Transfer
  • Facility Management & Integration
  • Capacity & Facility Design
  • Multi product facilities
  • Energy & Operational Efficiency
  • Lean/Transformational Change – Operational Excellence
  • Continuous Improvement / Manufacturing Processing
  • PAT & MES, Automation and Process Control Excellence
  • QbD
  • Quality Assurance & Quality Systems
  • Regulation – Rapid Release Testing
  • Finance / Inward & Foreign Investment
  • cGMP – Contract, External Manufacturing Services
  • Biogenerics/Biobetters
  • Personalised Medicines
  • Cell & Gene Therapy
  • Fill and finish
  • Cold chain
  • Microbial Process Development and Production

16.05 – 16.35

A Journey in Continuous Protein A Chromatography

  • Implementation of a continuous protein A capture process for antibody applications embedded in an end-to-end single-use GMP manufacturing process of a multispecific mAb.
  • Moving to a more heterogeneous portfolio of antibodies and fusion proteins, more flexibility and lower expenditure.
  • Demonstrating benefits of single-use equipment and continuous processing

16.35 – 17.05

NextGen SUB Applications

  • Evaluations of new single-use bioreactor design providing improved mass transfer and power per volume
  • Utilizing unique drivetrain and vessel geometry.
  • Scalability across multiple vessel sizes, sustaining higher cell densities
  • SUB design including a high turndown ratio, enabling multiple seed train stages to take place in a single vessel increasing operational efficiency and reduces facility footprint.
  • Case example in process intensification

17.05 – 17.35

Complete single-use upstream workflow from process development to clinical manufacturing to rapidly advancing biologics programs

  • Single-use high-throughput bioreactor systems greatly increase development capability and efficiency
  • Detailed bioreactor characterization effort enables seamless scale-up and process transfer from high throughput mini-bioreactors to clinical scale at 2,000 L
  • Streamlined workflow leads to rapid and efficient FIH process development
  • Potential acceleration to late stage development and characterization using the same single-use equipment and methodology

17.40 – 18.15

Next-generation bio-manufacturing capabilities and state-of-the-art technologies at Amgen Rhode Island

  • Accelerating the transformation of our pipeline to deliver the next generation of medicines for patients and achieving long term competitiveness
  • Increased bulk production through next-generation biomanufacturing platforms incorporating advanced manufacturing technologies, single use, digitalization and material sciences
  • Greater flexibility, speed and efficiency to manufacture multiple medicines simultaneously.
  • Smaller manufacturing footprint offering environmental benefits such as reduced water consumption and energy and lower levels of carbon emissions.

James Pierce, Director Process Development, Amgen

17.40 – 18.15

Management of outsourcing network

  • Outsourcing essentials for a successful transfer and commercial launch?
  • Leading outsourcing operations in early to late-stage process development
  • Developing and sustaining internal and external skill set.
  • Sourcing of appropriate external partners
  • Increasing efficiency and performance of the outsourced network

Siddhartha Shrivastava, Head, North America Technical Operations – EMG, Sanofi

18.15

CHAIRPERSON’S CLOSING REMARKS AND END OF DAY ONE

18.20

NETWORKING DRINKS RECEPTION

DAY TWO

08.30 – 08.35

CHAIRPERSON’S OPENING REMARKS FOR DAY TWO AND SUMMARY OF DAY ONE

08.35 – 09.10

Plant Design Philosophy and Technology Transfer Strategy

  • Design Basis for a new facility
  • Utilizing Data Management and Digital tools as part of facility design concept
  • Outlining a complex node to node technology transfer
  • Validation strategy to meet an aggressive timeline

Anu Bansal, Director Manufacturing Science and Technology, Genentech

Downstream Processing

Upstream Processing

Chaired by Ishaan Shandil Senior Engineer,
Process Engineering and MT External MFG, Bristol-Myers Squibb

09.15 – 09.45

Impurity Control Strategies and Challenges in Impurity Reduction Studies

  • Different impurity control strategies
  • Pro’s and con’s for different strategies
  • Case study: Antifoam reduction study
  • Technical and analytical challenges met in reduction study

Markus Eser, Lab Head Downstream Processing & Analytics, Bayer

09.15 – 09.45
Moving from intenstified fed-batch to an integrated continuous process

  • Case study evaluation of a molecule evaluated both in an intensified fed-batch process and in a perfusion integrated with continuous capture process.
  • Perfusion optimization using operational parameters and cell culture media design
  • Delivering a target product quality profile with perfusion in consideration of historical product quality data
  • Residence time distribution characterization in a perfusion process integrated with continuous capture
  • Economics of stainless-steel intensified fed-batch versus a single use integrated continuous format

Sarwat Khattak, Senior Engineer III, Biogen

09.50 – 10.25
Fine-Tuning Process Development, Scale-up and GMP Manufacturing of a Novel ADC Technology Platform

  • Overview of Complex Supply Chain Architecture for ADC Manufacturing
  • QbD-based Strategy to Process Validation of Key Process Parameters
  • Process Scale-up Case Studies
  • Brief clinical update Mersana’s Dolaflexin ADC XMT-1536

Daniel Custar, Associate Director, CMC Drug Substance, Mersana Therapeutics

09.50 – 10.25

Upstream Process Modelling: From Early Stage to Late Stage

  • Strategy to integrate modeling during process development. What kind of Model could be used to accelerate process development and when?
  • Case studies on the application of modelling and statistics: media optimization, process development (fed-batch and perfusion)
  • Decision making tool: what should be required to help select the best process for the right molecule?
  • Limits of modelling for upstream process development and future direction

10.25 – 10.50

COFFEE BREAK & MEETINGS

10.50 – 12.20

One to One Meetings

  • Downstream/Upstream Process Technology Platforms
  • Specialised cell culture media
  • Single-use & Disposable Technologies
  • Smart Manufacturing Technologies – Technology Transfer
  • Facility Management & Integration
  • Capacity & Facility Design
  • Multi product facilities
  • Energy & Operational Efficiency
  • Lean/Transformational Change – Operational Excellence
  • Continuous Improvement / Manufacturing Processing
  • PAT & MES, Automation and Process Control Excellence
  • QbD
  • Quality Assurance & Quality Systems
  • Regulation – Rapid Release Testing
  • Finance / Inward & Foreign Investment
  • cGMP – Contract, External Manufacturing Services
  • Biogenerics/Biobetters
  • Personalised Medicines
  • Cell & Gene Therapy
  • Fill and finish
  • Cold chain
  • Microbial Process Development and Production

10.50 – 11.20
High Productivity Harvest- Intensify and displace clarification in Fed Batch cell culture

  • How can I gain from process intensification with the least effort?
  • Should I retrofit my facility to become continuous or not?
  • Is it possible to introduce intensification changes in late clinical or post commercial phases?

11.20 – 11.50
Improving single use bioreactor design and process development

  • Improve performance and control when operating under these special conditions
  • Impacts of enhanced energy transfer-Implementing bottom heat exchange, alternate impeller positions, and
    considering agitation dissipation rates
  • How new technology improves equipment utilisation, scheduling efficiency, inventory logistics, and reactor harvest consistency?

11.50 – 12.20
Challenges during the Development of a High Cell Density (HCD) Continuous Upstream Process and Evaluation of an Ambr15 Perfusion-Mimic model

  • Impact of the quality and quantity of cryopreserved cells
  • Development of media able to support high cell density cultures
  • Availability of rapid analytical tools which are capable to measure CQAs at small harvest quantities
  • Micro control of a continuous cell culture process
  • Minor equipment failure leads to serious impact on performance
  • Challenges and importance of PAT during small scale runs

12.20 – 13.10

NETWORKING LUNCH

Process Development

Chaired by Natraj Ram, Senior Director, Biologics Process Development, Alkermes

Upstream Processing

Chaired by Ravali Raju, Principal Scientist, Pfizer

13.10 – 13.45

Streamline Downstream Process Characterization to Accelerate Late Stage Development for Process Performance Qualification

  • Process characterization (PC), a lengthy process required for performance qualification
  • QbD Approach for process characterization study design
  • Various study approaches and statistical data analysis tools evaluated to shorten timeline
  • Streamline PC methodology for mAb platform to accelerate late stage development
  • A mAb case study presented, challenges and bottle necks identified, future solutions provided with lesson learned

Yi Liu, Senior Scientist DSP, Bayer

13.10 – 13.45

The Evolution of a Next Generation, High-Intensity Manufacturing Process – A Pfizer Update

  • The evolution of a Boehringer Ingelheim, Pfizer collaboration design of an intensified, next generation manufacturing process
  • The evolution from a proof of concept system through GMP design considerations is a significant challenge
  • New integrated skid (iSKID) assimilates, prototype system increases process efficiency
  • They system integrated iSKID is capable of 24-hour, unmanned operation, delivering superior daily productivity to traditional batch processing in a low bioburden environment
  • Learnings from the prototype system play a significant role in the design of a GMP bioprocess manufacturing system

Michael O’Connor, Senior Engineer, Pfizer
John Galyas, Senior Associate Scientist, Pfizer

13.50 – 14.25

Parallelized DSP steps with a single-skid at pilot-scale: manufacturing strategies, buffer platforms and equipment integration

  • We performed advanced trials of a pilot-scale equipment allowing several DSP steps to be performed at the same time
  • The strategy employed was: multi-column capture step, followed by an automated viral inactivation step, followed by a depth filtration step paired with an ion exchange chromatography step.
  • We also tested several features of the equipment to apply different buffer platform strategies: 1X buffers, in-line dilution and an advanced inline buffer conditioning

13.50 – 14.25
Post-approval Lifecycle Management Strategies for Biopharmaceuticals

  • Post-approval CMC changes for biopharmaceuticals: what are the drivers, where do changes typically take place, what are the main obstacles & regulatory expectations
  • CMC changes: a shift of paradigm demanding greater flexibility
  • CMC Lifecycle Management: the risk & cost of getting it wrong
  • Strategies and tools to optimize the post-approval Lifecycle Management of Biologics
  • Case studies and FAQs

Philippe Baumgartner, Head of Biologics CMC, Global Manufacturing Sciences, Takeda

14.25 – 15.00

How to exit a commercial roller bottle process and fix the quality attributes for a complex protein. A joined Up – and Downstream Approach.

  • 2nd Gen Process Development (from roller bottles into bioreactors) for a complex non mab like protein
  • Significant Yield Increase and Cost Reduction
  • Joined Up- and Downstream approach to keep Quality Attributes within commercial range
  • Challenges during Upscale and Lessons Learned

14.25 – 15.00
End-to-End Engagement and Tools to Ensure Successful Tech Transfers

  • Discuss Amgen’s comprehensive approach to ensure right-first-time tech transfer
  • End to end tech transfer process evaluating raw materials, process design and control, facility fit, PPQ/Process Validation, and continued process verification
  • Modeling and tools to reduce cost and risks while accelerating tech transfer
  • Digital transformation shifting document driven to data driven tech transfer

Chae Han, Principal Scientist, Amgen

15.00 – 15.20

COFFEE BREAK

15.20 – 15.55

Process intensification strategies for modern bioprocessing facilities:

  • Approaches to eliminate manual steps in USP and to establish high cell density processes
  • Strategies to combine DSP unit operations
  • Intelligent buffer management solutions
  • Digitization and PAT to enhance process control

Stefan Schmidt, COO – Head of Operations, BioAtrium

15.55

CHAIRPERSON’S CLOSING REMARKS

16.00

CLOSE

Please Note: Workshop Agenda and Speakers can be subject to change