DAY ONE

07.45 – 08.30

Registration

08.30 – 08.40

Welcome & Chairman’s Opening Remarks for Day One

Bruno Figueroa, Global Head Cell Culture Development, Sanofi Genzyme

08.40 – 09.15

Current Trends in the Biotech Industry – Where Are we and where we going?

  • Current trends in biologics industry
  • Breakthrough in biotechnology R&D
  • What the future may look like?
  • Emergence of biosimilars: Challenges and opportunities

Rakesh Dixit, President & CEO, Bionavigen, LLC (formerly Vice President, R & D, MedImmune)

Next Generation Processing

Chaired: Bruno Figueroa, Sanofi Genzyme

Upstream Processing

Chaired: Ishaan Shandil, BMS

09.15 – 09.50

Evolution of a Next Generation, High-Intensity Manufacturing Process

  • System Overview
  • System Evolution
  • Key Accomplishments
  • Microbial Control

Ben Burford, Scientist – Pilot Plant, Pfizer
Philip McCormick, Senior Associate Scientist, Pfizer

09.15 – 09.50

Common denominators of process and life cycle control strategies

  • Capture your process knowledge in Digital Twins
  • Accelerate time to clinic by Digital Twin controlled experimental designs
  • Deploy your knowledge in real time model predictive control architectures enabling continuous manufacturing
  • Identify holistically relevant process parameters and anticipate life cycle variabilities using integrated digital twins

Dr. Christoph Herwig, Head Biochemical Engineering, TU Wien

09.50 – 10.25

Exploring Biomanufacturing Technology Trends – How Biogen’s Pilot lab plays a critical role in advancing technology development and manufacturing implementation

  • Pilot Scale’s role in process and technology development
  • Closer look at technology initiatives being explored at Biogen
    • Industry 4.0, Recipe Driven Operations, Continuous Manufacturing, Advanced Process Control
  • How will these trends and technologies impact the industry?
  • What are the next steps to realize the technological gains?

John Smelko, Sr. Manager, Drug Substance Pilot Operations, Biogen

09.50 – 10.25
An Extractables & Leachables Risk Evaluation Strategy for evaluating a Monoclonal Antibody manufacturing process

  • What drove the creation of an E&L strategy group for Biologics
  • What were the results of the initial Risk Evaluation conducted for Mab X and what were the drivers that
    arose from this evaluation that pushed towards a more “quantitative” based approach?
  • What were the main changes in strategy for the final risk mitigation design?
  • What were the results of the final risk evaluation strategy?

Todd Pascarella, Senior Research Scientist, Gilead Sciences

10.25 – 11.15

COFFEE BREAK & MEETINGS

11.15 – 11.50

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

Jason Lukasek, Senior Director of Global Sales, Bioprocess Equipment and Automation (BEA), Thermo Fisher Scientific

11.55 – 12.55

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

11.55 – 12.25
Opportunities, challenges, and economic drivers for intensified and connected biomanufacturing

  • Current state of biomanufacturing and how modernizing, intensifying, industrializing and connecting biomanufacturing workflow and unit operations can achieve superior outcomes
  • Leveraging smart bioprocessing to achieve productivity gains and how that ties into biomanufacturing of the future
  • Case studies and real-life examples

12.25 – 12.55

Bulk Filling and Shipping solutions

  • Single-Use Filter and Dispense System
  • Automated GMP solution
  • Fully Contained filling
  • Standard solution
  • Fill Bottles or Bags

12.55 – 13.45

NETWORKING LUNCH

Downstream Processing

Chaired: Ionela Iliescu, Scientist I, Biogen

13.45 – 14.20

Overcoming mAb manufacturing process challenges for high concentration drug substance to facilitate subcutaneous administration

  • UF/DF recovery flush strategy to enable high yields
  • Targeting excipient concentrations in UF/DF processes
  • UF/DF pressure limitations due to high viscosity
  • Sterile filtration challenges at high protein concentrations
  • Stability considerations at high concentration drug substance

Melissa Holstein, Senior Scientist – Process Development Downstream, Bristol Myers Squibb

Upstream Processing

Chaired: Ishaan Shandil, BMS

13.45 – 14.20

Ambr15 high throughput model development for perfusion

  • A high-throughput (HT) cell culture model has been established for the support of perfusion-based cell culture processes operating at high cell densities.
  • Varied different type of models has been evaluated with pro and con
  • The established model was able to apply in varied application such as clone screening, medium development, and new process development etc.

Jiayi Zhang, Manager Process Engineer/Development, Sanofi

14.25 – 15.00

Development and optimization of challenging unit operations with line of sight to manufacturing for a shear sensitive, aggregation prone, & low pI monoclonal antibody

  • Purification of difficult Proteins with low pI, self?association prone and shear sensitivity
  • HIC chromatography and Ultrafiltration development
  • High salt addition and protein instability
  • Shear models and prediction for large scale manufacturing

Sandra Rios, Principal Scientist, Merck

14.25 – 15.00
Implementation of HTST Media Treatment for Legacy Commercial Cell Culture Processes

  • The implementation strategy for HTST treatment of media and feeds for commercial cell culture processes is described in detail.
  • A risk-based approach was developed to determine the study design and identify appropriate mitigations prior to full-scale implementation.
  • A bridging study was conducted for a laboratory-scale HTST unit to establish a scale-down model to support future screening studies.
  • Operational challenges were encountered on the large-scale HTST unit which had an impact on process performance. Results of the investigation and associated corrective actions are described

Brian Kenty, Senior Scientist, Astrazeneca

15.05 – 15.40

Implementation of Design Space Strategy to Control Product Quality during Large Scale Purification of Therapeutic Proteins

  • Lot-to-lot resin variability – Case study
  • Risk assessment and mitigation
  • Process control strategy
  • Regulatory considerations

Ionela Iliescu, Scientist I, Biogen

15.05 – 15.40

Development of An Intensified Manufacturing Process for Single-Use Clinical Manufacturing Facility

  • New clinical manufacturing suite in Devens site has been built with the intention of implementing a hybrid continuous manufacturing model that can increase monoclonal antibody output
  • In the upstream process, a perfusion process has been developed for the seed train to increase cell densities of fed-batch process, reduce cadence and enhance annual antibody output. The perfusion seed train implemented the use of capacitance probes to control perfusion rate and minimize media utilization.
  • Accompanying high density fed-batch process, a new platform media has been developed for basal and feed to enhance productivities.
  • A clone selection workflow has also been adapted to accommodate the transition to a high density fed-batch process from the previous fed-batch platform approach.

Charles Hill, Associate Scientist, Bristol Myers Squibb

15.40 – 16.30

COFFEE BREAK & MEETINGS

16.30 – 18.00

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

16.30 – 17.00

Using Alluvial Filtration as an Effective and Economical Solution for Midstream Clarification

  • Alluvial filtration compare to other technologies
  • Economic approach for Midstream 7 Clarification
  • Robust technology – easy scalable

17.00 – 17.30

Scalable Single-Use Platform for Intensified Downstream Processing

  • Upstream Process Intensification places additional demands on Downstream Processing
  • Cost-effective solutions for high cell density clarification
  • Single-use, scalable Membrane Adsorbers can be easily adapted into connected/continuous DSP
  • Extended-use Virus filters challenge traditional approach
  • Scalable Single Use & single-pass TFF options will be discussed

17.30 – 18.00

Innovation, a key solution to cell therapy automation challenges. Practical steps to integrate automation into Cell Therapy and improvements to GMP.

  • Challenges in cell therapy manufacturing
  • What is innovation and how can we integrate it in GMP
  • Evolution / Revolution
  • Examples of innovations in other fields and in cell therapy
  • Practical steps of innovating in cell therapies.

18.05 – 18.40

Using SPOT™ and SLIM™ technologies and upstream process modulation to reduce cost of goods of manufacturing

  • Increase specific productivity using SPOT™
  • Increase specific productivity and biosimilar product quality using upstream process modulation
  • Reduce process hardware limitations using SLIM™ technology
  • Reducing cost of goods of manufacturing

Dr. Louis Boon, CSO, Bioceros

18.40

CHAIRPERSON’S CLOSING REMARKS AND END OF DAY ONE

18.45

NETWORKING DRINKS RECEPTION

DAY TWO

09.00 – 09.10

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

Bruno Figueroa, Global Head Cell Culture Development, Sanofi Genzyme

09.10 – 09.45

Biosimilars – Differentiation as a success factor

  • Regulators Perspective
  • Biosimilar Landscape
  • Differentiators for success:
  • Manufacturing considerations
  • Technical Development Considerations
  • Interchangeability
  • Portfolio Selection

Norbert Bleich, COO & CMO, Valeriusbio

09.45 – 10.20

Operating a multiproduct facility: the critical role of process simulation

  • Modeling a long range production plan
  • Measuring facility utilization
  • Identifying equipment bottlenecks
  • Identifying resource constraints
  • How process variability effects throughput
  • Integrating real time facility analytics

Ian Gosling, Process Modelling Specialist, Biogen
Chris Antoniou, Distinguished Engineer, Biogen

10.20 – 10.55

Leveraging ICB and at-scale development for a diverse biologics portfolio

  • Integrated and continuous biomanufacturing (ICB) can enable process intensification and process development at manufacturing scales
  • This presentation will highlight a Sanofi case study on the commercialization of an ICB process (for unstable molecule) that demonstrates the benefits of at-scale development
  • A second Sanofi case study on strategic considerations of choosing an ICB process for a stable molecule will also be presented

Rohan Patil, Principal Scientist, Genzyme

10.55 – 11.20

COFFEE BREAK & MEETINGS

11.20 – 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

11.20 – 11.50
MabXpure and Innovative Strategies for Enhancing Host Cell Protein Clearance in Downstream Operations

  • HCPs, DNA and other contaminants removal from the bulk, and especially co-eluted HCPs
  • Development of a single-use impurities depletion technology to be used under flow-through conditions and during clarification / polishing steps in downstream operations – Case study of implementation (Sanofi and Polyplus Transfection)
  • Envisioning its use in an optimized platform with process intensification possibilities or as a unique
    solution for sample preparation

11.50 – 12.20
glyXbox: A powerful glycoanalytical toolbox – improving biologics development

  • High performance glycoanalysis – combining expertise & pace
  • Glycomics, Glycoproteomics & Glycopeptidemapping
  • Glycoanalysis on 3 levels: glycofingerprinting, glycoprofiling & site-specific glycoanalysis
  • Cutting edge glycoanalytical products & services, tailored to the specific needs of our customers

12.20 – 13.10

NETWORKING LUNCH

Downstream Processing

Chaired: Rohan Patil, Principal Scientist, Sanofi Genzyme

13.10 – 13.45

Process development and manufacturing of Antibody Drug Conjugates

  • Process development and challenges for different ADC platforms
  • Strategies for ADC manufacturing
  • Control of product heterogeneity
  • Improvement for future processes

Guy de Roo, Principal Scientist, Synthon

Upstream Processing

Chaired: Ishaan Shandil, BMS

13.10 – 13.45

Advanced enablers for continuous biomanufacturing

  • Robust downstreaming starts with robust upstreaming
  • Population analysis in induced continuous upstream processing
  • Focus on the integrated process rather on single unit operations
  • Control strategies based on
    • PAT
    • Data Management and Data Science

Dr. Christoph Herwig, Head Biochemical Engineering, TU Wien

13.50 – 14.25

Development and Manufacturing of High DAR (10-15) ADCs Utilizing the Dolaflexin® Platform

  • A clinical-scale manufacturing process for Dolaflexin-containing ADCs has been developed
  • The manufacturing process has produced Dolaflexin-ADCs with excellent batch-to-batch consistency
  • The reduction and purification steps to generate the ADC can be used as control points to ensure high quality and in specification Dolaflexin-containing ADCs
  • The clinical profile of Mersana’s Dolaflexin ADC XMT-1536 is currently in a Phase 1 clinical trials

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

14.25 – 15.00

Implementation and validation of a single-use mixing system for virus inactivation with solvent / detergent

  • Virus inactivation by solvent Detergent treatment
  • Single Use System
  • Scale-down model for S/D Virus inactivation
  • Steps of the validation (temperature mapping ; Homogeneity study; …)
  • Impact of the EU Reach regulatory authority on S/D IV processes

David Balbuena, Head of Manufacturing, LFB Biomanufacturing

15.00 – 15.15

COFFEE BREAK

15.20 – 15.55

Open Panel Discussion: 
With next gen manufacturing technologies and processes and strategies emerging what gains are being realised for profitability, productivity and quality in future facilities?

  • Assessing the benefits and drawbacks of the latest manufacturing technology trends
  • How Single-use equipment can help achieve performance improvements, both for downstream purification and for manufacturing productivity overall
  • Process and Product Considerations for Flexible Manufacturing
  • How Process Technology Platforms can be used to Optimize areas and parameters in upstream processing and automation opportunities to improve productivity and quality
  • Process intensification strategies in USP and DSP shortening process time

Moderator: 

Bruno Figueroa, Global Head Cell Culture Development, Sanofi Genzyme

Panellist:

Chris Antoniou, Distinguished Engineer, Biogen

Scott Gangloff, Vice President, Biologics Product and Process Development, Incyte

15.55

CHAIRPERSON’S CLOSING REMARKS

16.00

CLOSE

Please note: Agenda and speakers are subject to change.