2015 Archived Content

Breakout Discussions

Monday, August 3, 2015 | 4:15 - 5:15 pm

This session provides the opportunity to discuss a focused topic with peers from around the world in an open, collegial setting. Select from the list of topics available and join the moderated discussion to share ideas, gain insights, establish collaborations or commiserate about persistent challenges. Then continue the discussion as you head into the lively exhibit hall for information about the latest technologies.

Biosimilar Development: Cell Line Screening and Process Optimization – The Right Balance?

Moderator: Arnaud Perilleux, Assistant Project Manager, Biotech Process Science, Merck Serono SA

Approaches to Establishing Product Specifications from Early Clinical Development to Commercial

Moderator: To be Announced

Integrating Continuous Up- and Downstream Processing to Increase R&D Protein Production

Moderator: Martin Heitmann, Ph.D., Senior Scientist, Cell Culture Technology, Novo Nordisk A/S

Novel Production Systems and Regulatory Considerations

Moderator: To be Announced

Feeding Strategies for High Density CHO to Keep Cells Growing Longer in Log Phase. Surfactants, how much and what is the best?

Moderator: Sam Ellis, Vice President, Biochemist, Thomson Instrument Co.

  • Pluronic vs. Simithecone; does your media have enough surfactant for high density CHO
  • Amount of Surfactant needed?
  • Transient effects?
  • Stable CHO needs for surfactants?
  • Glucose, Glutamate, cell boost, what should we do?

Solving Development Issues with Large-scale Transient Transfection

Moderator: James Brady, Ph.D., Vice President, Technical Applications and Customer Service, MaxCyte

  • De-risk development with transient transfection of the manufacturing cell line
  • Shorten development timelines with large-scale transient transfection
  • Scale-up/Scale-down of transient transfection
  • Using Stable cell lines versus transients downstream

What Does It Take To Move A Formulation From Vials To Prefilled Syringes?

Moderator: Mark Yang, Ph.D., Director, Fill Finish Development, Genzyme - a Sanofi Company

  • What are the most efficient ways to evaluate the device-ability of current formulations?
  • What are the “norms” for development timelines and budget?
  • Key development steps/challenges to move from vials to prefilled syringes

What Constitutes A Critical Excipient?

Moderator: Michael T. Jones, Ph.D, Research Fellow, Biotherapeutics Pharmaceutical Sciences, Analytical R&D, Pfizer, Inc.

  • Are specific excipients required for a stable formulation or would similar excipients work as well?
  • What concentration of the excipient is required to guarantee it’s function?
  • At the end of shelf-life, does the DP still meet all of the specifications required regardless of excipients present?

Formulation Development of the Future – Can We Develop Better Formulations Faster?

Moderator: Russell Burge, Ph.D., Applications Scientist, Freeslate, Inc.

  • Can automation help accelerate formulation development? What are the best approaches to continue with rapid and innovative formulation development?
  • Are current analytics sufficient? What improvements are needed to provide better characterization faster?
  • What are the best practices for implementing QbD in formulation development?

Chimeric Antigen Receptor (CAR)-T Cells: History, Success, Challenges and Advancement

Moderator: Pranay D. Khare, Ph.D., Independant Consultant

  • CAR molecule development and advancement
  • CAR-T cell manufacturing
  • CAR-T cell safety and efficacy

Hidden Challenges in Cell Therapy Processing

Moderator: Knut Niss, Ph.D., CMC Team Director, PO&T, Biogen

  • Assays needed vs. assays wanted
  • Speed vs. cost
  • Supply chain issues

Regulatory Pathways and Differences in US, Europe and Japan – Opportunities for Accelerating Development

Moderator: Anthony Davies, Ph.D., President, Dark Horse Consulting, Inc.

Best Practices for Analytical Support of Product Quality

Moderator: Stephan O. Krause, Ph.D., Director, QA Technical Support, AstraZeneca Biologics

  • Specification setting
  • Method life cycle (AMQ, AMV, AMT)
  • Accelerated program considerations: specifications, AMV, etc.
  • USP <129>
  • ICH Q3D
  • Analytical similarity (biosimilars): acceptance criteria, sample size, comparison model(s) etc.

How to Build a QbD Infrastructure in CMC from Early Phase Drug Development Without Impacting Timelines and Resources

Moderator: Zhimei Du, Ph.D., Principal Scientist, Teva Pharmaceuticals

  • What is the right time to define quality target product profile (QTPP)?
  • How much effort is appropriate to determine critical quality attributes for early phase drug development?
  • How to define critical process parameters?
  • What is the right design space for early phase drug development?

Process Characterization Studies

Moderator: Angela Lewandowski, Ph.D., Manager, Biologics Process Development, Bristol-Myers Squibb

  • What is your strategy for the risk assessment in determining CQAs prior to process characterization studies? What data/studies is your risk assessment based on? What type of risk assessment is performed?
  • What is your strategy for determining the ranges evaluated in process characterization studies? Do you focus on bracketed ranges around the expected normal operating range (NOR)? If so, how do you determine the bracketed range? Or, do you probe the “edge of failure”?
  • What is your strategy for determining which impurities to evaluate in spiking/clearance studies during process characterization?
  • What is your strategy for determining Critical Process Parameters (CPPs) versus non-CPPs? Do you have a systematic and quantitative system? Or is this based on subject matter expertise? What type of risk assessment is performed?
  • What is your strategy for determining which non-CPPs, if any, to include in the marketing application? Is there a systematic methodology? Have you received health authority feedback on number of CPPs versus non-CPPs or on your methodology?

What are Current Control Strategies for Submicron and Subvisible Particles in Biologics?

Moderator: Nataliya Afonina, Ph.D, President and Principle Consultant, AN Biologics Consulting LLC

  • How protein aggregation in 0.1 -10 μm particle range may impact CQA related to product quality and purity?
  • What are regulatory expectations?
  • How industry is handling and controlling subvisible and submicron particles?

Commercial Release Specification Setting

Moderator: Paul Bigwarfe, Ph.D., Director, Analytical Sciences, Regeneron Pharmaceuticals, Inc.

  • Control strategies for various product forms/production stages
  • What tests are necessary?
  • Justification of acceptance criteria

Admixture Testing Strategy

Moderator: Shenjiang Yu, Ph.D., Associate Principal Scientist, Sterile Product and Method Development, MRL, Merck Co. & Inc.

  • Clinical support and regulatory expectation
  • Analytical tool box and strategy
  • Special analytical development and investigation

Wednesday, August 5, 2016 | 3:30 - 4:00 pm

Perfusion processes have several advantages, which make them perceived as possible solutions for the future. What are the impediments for perfusion process expansion today and how should we tackle these?

Moderator: Veronique Chotteau, Ph.D., Principal Investigator, Cell Technology Group, School of Biotechnology, KTH, Royal Institute of Technology


  • Material: such as equipment for perfusion, scale-up or scale-down
  • Cultural and pragmatic: why change something which is legacy and working well?
  • Knowledge: the community has not the knowledge today, either from not enough published information or not enough trained "perfusion people"


An Examination of Barriers to the Commercial Adoption of Continuous Processes for Production of Biologicals

Moderator: Todd Przybycien, Ph.D., Professor, Chemical Engineering and Biomedical Engineering, Carnegie Mellon University


  • Regulatory hurdles – who goes first?
  • Critical path hurdles – how long to develop and validate?
  • Process development hurdles – are scale-down models available for development efforts?
  • Process hurdles – how robust are integrated processes to fluctuations?
  • Equipment hurdles – how robust is the equipment – particularly for single use formats?
  • Monitoring and control hurdles – is the available PAT sufficient to support the necessary level of automated control?
  • Economic hurdles – what are the current rosy economic predictions missing?



The Challenges of Keeping Pharmaceutical Aging Facilities Fit for Purpose

Moderator: Morten Munk, Senior Technology Partner, Global Business Development, NNE PharmaPlan


  • Aging facilities are a major concern for industry and regulators, due to the risk of supply of suboptimal quality products and possibly drug shortage situations
  • Share insights on the challenges and what might hold the industry back from implementing up-to-date solutions
  • Discussion on the facilities, processes, analytical methods and manufacturing control strategies
  • Special focus on the regulatory impact and strategy for implementing the needed changes in all the mentioned areas



Implementing Continuous Bioprocesses in GMP Manufacture

Moderator: Peter R. Levison, Ph.D., Senior Marketing Director, Downstream Processing, Pall Life Sciences

  • Assuming the purification technologies and materials used in both batch and continuous processes are identical are these processes interchangeable during design, development, scale-up and production?
  • Large fed batch culture is today’s start point for DSP. Does the future include a series of staged smaller fed batch bioreactors and/or perfusion cell culture processes
  • What other platforms and/or continuous processes are required for non-Mab applications?


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