CONFERENCE SERIES: Biological Therapeutic Products 

Recorded at: PEGS: The Essential Protein Engineering Summit 

Digital Course: Characterization Techniques For Protein Therapeutics - Orthogonal Vs. Complementary 

 


Order DVD2011 SC9 DVD Cover About this Product: 

This digital course covers the theory and general application of both traditional and emerging technologies suitable for protein therapeutic characterization, across the applicable size range of 1 nm to 100 um. Historically, quantification of protein aggregates in pharmaceutical formulations had been assessed almost exclusively using size exclusion chromatography (SEC) in the nm size range and light obscuration in the micron size range. Given recent concerns regarding the potential of undesirable immune responses to protein aggregates, the FDA is recommending 1) the use of orthogonal techniques to support SEC results, and 2) an expansion of the technology portfolio to include those suitable for particle sizes beyond the upper limits of SEC. This workshop covers the range of technologies suitable for satisfying these FDA recommendations, with a focus on orthogonality vs complementarity, using real world examples. Representative Discussion Points 

  • What’s the difference between Tm measured by DSC, CD, & DLS? 
  • Can DLS be used to confirm SEC results? 
  • What’s the relevance of protein charge on formulation stability? 
  • Can particle counting be achieved in the 100 nm to 1 um size range? 
  • What role does protein aggregate “morphology” play? 

 

Preview: 

 

About this Product: 

3 Presentations
88 Slides
Over 194 Minutes
Individual: $345Site License: $1380

 

 

 

Agenda At A Glance: 

Current Industry/FDA Talking Points
Kevin Mattison Kevin Mattison, Ph.D., Principal Scientist Bioanalytics, Malvern Instruments 

Biography: Dr. Mattison completed his doctorate in biological chemistry at Purdue University, where he studied the effects of polyelectrolyte additives on the stability and activity of transport proteins and enzymes.  From there he joined Protein Solutions as the Applications Development and Technical Support Manager, and was instrumental in helping to drive the adoption of sub-micron light scattering techniques from esoteric technologies into main stream laboratory tools.  In 2002 Dr. Mattison joined Malvern Instruments, where he served as Applications Manager, Product Manager, and Director of Customer Support, prior to assuming his current position as Principal Scientist – Bioanalytics in the Strategic Technology Development Group.

Technology Landscape
Jason Sanchez Jason Sanchez, Ph.D., Product Manager, GPC/SEC Technologies, Malvern Instruments 

Biography: Dr. Jason Sanchez is currently the Product Manager for GPC/SEC Technologies at Malvern Instruments. Jason joined Malvern in 2008 from the University of California, San Diego where he received his M.Sc. (2006) and Ph.D. (2008) on his work in the field of photoluminescent sensors. He holds five patents and eight publications for his work in this field. Jason’s current focus is on developing the utility of advanced detection GPC/SEC in emerging application areas.

Complementary Techniques
Ulf Nobbmann Ulf Nobbmann, Ph.D., Senior Applications Specialist, Nanometrics, Malvern Instruments 

Biography: Dr. Ulf Nobbmann received his Ph.D. in colloidal physics from Oklahoma State University and has since focused on light scattering from biological molecules and nano particles.  He joined Malvern Instruments in 2003, where his current role is Specialist for Nanometrics, involved in training and development of application knowledge and expertise.

 

About the Conference: 

PEGS is the essential antibody and protein engineering event of the year, where what you learn can be directly applied to your work. The event provides 1,200+ participants to network with their peers and learn about unpublished science in the session rooms. Delegates engage in problem solving breakout discussions and gain insight from over 60 exhibitors, and view the 155 posters in the exhibit hall.