Date: 25 - 29 Apr 2016 Location: Seaport World Trade Center City: Boston, MA Country: USA Visit the event website for more information Booth 428



PEGS 2016





Dr. Atanas Koulov


Atanas Koulov, Ph.D


Head, Analytical Development and QC, Drug Product Services 
  Wednesday, April 27, 4:45pm: Problem-solving Breakout Discussion, Subvisible Particles and Biotherapeutics


  -  Particle characterization methods and their application in development

  -  Biological consequences of subvisible particles in biotherapeutics

  -  Product-specific limits for subvisible particles - how to set specifications


Thursday, April 28, 9:05am: The Known Unknowns in Subvisible Particle Characterization - Factors Governing the Analytical Performance of Subvisible Particle Measurement Methods


Although the biopharmaceutical community is actively using a number of techniques for subvisible particle characterization, the current knowledge of the analytical performance of these tools is inadequate to support their routine use in the development of biopharmaceuticals.  This talk will outline some recent efforts to increase this knowledge by systematic evaluation of the analytical performance of the principal subvisible particle characterization techniques and also will provide analysis of the fundamental factors governing it.


Yvette Stallwood


Yvette Stallwood, Ph.D


Head, Applied Protein Services
  Thursday, April 28, 9:35am: Predicting, Avoiding and Reducing the Risk of Failure when Developing Biotherapeutics


This presentation will discuss in silico and in vitro methodologies used for developability and immunogenicity risk assessment to highlight potential failure risks for biotherapeutic development.  In silico methods can be used to evaluation protein sequence and structure to assess the likelihood of immunogenic responses and potential manufacturability issues including aggregation and PTMs.  Ex vivo T- and B-cell responses enable assessment of overall immunogenicity risks; different approaches are highlighted to further identify processes and presented epitopes.


Thomas Rohrer


Thomas Rohrer


Senior Manager, Antibody Drug Product Evaluation
  Thursday, April 28, 9:35am: Delivering the Future of Oncology - Manufacturing Next Generation Bioconjugates and Combination Therapies


  -  A brief history of oncology treatments and bioconjugates

  -  Lessons learned and challenges associated with ADCs

  -  What does the future look like for ADCs? Novel conjugation technologies, cytotoxic drugs, and different linker chemistries

  -  How the experiences from one manufacturing technology may be applied to the future of oncology

Prof.Dr. Hanns-Christian Mahler


Prof. Dr. Hanns-Christian Mahler


Head, Drug Product Services
  Friday, April 29, 9:35am: The Role of Surfactants in Managing Protein Aggregation


Non-ionic surfactants are commonly used in protein formulations to protect the protein from aggregation and particle formation.  Polysorbates can undergo auto-oxidation, cleavage at ethylene oxide subunits and hydrolysis of fatty acid ester bonds. Possibly, the cascade of degradation may impact product quality, e.g., formation of hydroperoxides and degradation products that may impact protein stability.  This talk aims to discuss benefits and concerns related to the use of surfactants in formulations.