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2014 Archived Content

Cambridge Healthtech Institute’s Tenth Annual
Recombinant Protein Therapeutics
Fusion Proteins and Beyond
January 13-14, 2014

 

Day 1 | Day 2 | Download Engineering Brochure | Speaker Biographies 

TUESDAY, JANUARY 14

7:15am  Conference Registration

7:30  Breakfast Presentation (Sponsorship Opportunity Available) or Morning Coffee


Overcoming Production Challenges 

8:30  Chairperson’s Remarks

Jennifer Cochran, Ph.D., Associate Professor, Bioengineering & Chemical Engineering, Stanford University

8:35  Structural Variation among Antibody Fc Fusion Proteins for Human Therapy

Steven ChamowSteven Chamow, Ph.D., Principal Consultant, Chamow & Associates, Inc.

The potential therapeutic value of many proteins can be realized by fusing these proteins to the Fc region of human immunoglobulin G. Of the 39 mAb and mAb-derivative products approved as human therapeutics in the USA to date, 7 are Fc fusion proteins. Among the approved products are several structural variations on the classical design of Fc fusion proteins that presented unique challenges during development. These and production issues that distinguish this drug class will be discussed.

9:05  Microalgae as a Production Platform for Recombinant Oral Vaccines

Elizabeth SpechtElizabeth A. Specht, Ph.D., Scientist, Biological Sciences, University of California, San Diego

Microalgae are ideal candidates for producing recombinant therapeutics, owing to their ability to properly fold complex proteins and their rapid growth. They are particularly attractive for producing orally-available vaccines – especially for developing-world diseases for which traditional purified vaccines are not economically feasible – because they are also edible. We have produced a properly folded malarial transmission-blocking vaccine antigen in algae and demonstrated its efficacy. Current work aims to increase antigenicity by targeting to the gut-associated lymphoid tissue for oral vaccine development.

9:35   Selected Poster Presentation:
C307 Platelet Activation-Induced Proteolysis and Protein Secretion

Mari Enoksson, Ph.D., Senior Scientist, Haemostasis Biochemistry, Novo Nordisk A/S

9:50  Coffee Break in the Exhibit Hall with Poster Viewing

10:50  Functional Production of a Peptide-Antibody Bispecific Genetic Fusion and Biological Influences of Therapeutic Protein Modifications throughout Trafficking

Xiaotian ZhongXiaotian Zhong, Ph.D., Principal Scientist & Lab Head, GBT, Pfizer Global BioTherapeutic R&D

We have generated a peptide-antibody bispecific therapeutic fusion protein in mammalian cells by combining an anti-IL17A peptide and an anti-IL22 antibody into a single open reading frame. Generating such a functional peptide-antibody bispecific therapeutic fusion requires pyroglutamate addition and O-linked glycan removal. The peptide-antibody genetic fusion is promising for targeting multiple antigens in a single antibody-like molecule. The talk will also summarize therapeutic influences and molecular mechanisms of therapeutic protein modifications throughout trafficking for functional characteristics and protein attributes.

11:20  Solving Purification and Production Issues of Therapeutic Fusion Proteins

Stefan SchmidtStefan Schmidt, Ph.D., Vice President, DSP, Rentschler Biotechnology

Fast and cost-efficient processing to deliver homogeneous material for clinical studies is a key challenge for therapeutic fusion proteins. Here, selected case studies of a wide spectrum of fusion proteins are presented that demonstrate how to overcome the typical difficulties such as absence of a traditional platform technology, low titer, lack of an affinity matrix, tendency to aggregate, etc. Additionally, practical advice will be given about what “manufacturability” parameters to consider when designing a novel molecule.

Lonza11:50 Developability: Reducing the Risk of Failure of Biotherapeutics

Blaser_GeorgGeorg Blaser, Ph.D. Group Leader, Applied Protein Services, Lonza Biologics

The ability to assess and de-risk a therapeutic candidate as early as possible in development can be a very powerful tool to enhance the candidate selection process and overall chance of success. This presentation will discuss how a number of in silico and in vitro methodologies can be employed to perform a developability assessment and to highlight potential risks of failure which include: safety and immunogenicity, stability/aggregation, and low productivity.

12:20 pm Luncheon Presentation (Sponsorship Opportunity Available) or Lunch on Your Own



BUZZ Sessions png

2:00 BuzZ Session A (More Details >>)

3:00 Refreshment Break in the Exhibit Hall with Poster Awards

3:45 BuzZ Session B (More Details >>)


4:45 Close of Conference


4:30-5:00 Short Course Registration

5:00-8:00 Dinner Short Courses (SC8-SC14) More Details >> 




Day 1 | Day 2 | Download Engineering Brochure | Speaker Biographies