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Cambridge Healthtech Institute’s Inaugural
Process Development for Novel Biotherapeutic Formats
Part of CHI’s 6th Annual The Bioprocessing Summit
August 20-21, 2014 | Renaissance Boston Waterfront Hotel | Boston, Massachusetts


Day 1 | Day 2 | Short Courses | Download Brochure | Speaker Bios 

Thursday, August 21

8:00 am Registration and Morning Coffee


CASE STUDIES OF DOWNSTREAM PROCESSING

8:25 Chairperson’s Remarks

AmithNaikAmith Naik, Ph.D., RAC, Senior Scientist, Biomanufacturing Training and Education Center, North Carolina State University




8:30 Process Development Challenges for FGF21 Protein-Antibody Conjugates

RoryFinnRory Finn, Principal Scientist, Conjugate and Polytide Process Development, Biotherapeutics Pharmaceutical Sciences, Pfizer

One strategy for improving the pharmacokinetics and potency of peptides, proteins or other bioactive molecules is through conjugation to antibody scaffolds engineered with specific  attachment sites.   The complexity of such molecules presents unique challenges for developing processes viable for clinical and commercial manufacturing.    This presentation will focus on the pilot scale process development optimization for two protein-antibody  clinical candidates:  1) a FGF21 analog protein– antibody conjugate, and 2) an asymmetric bi-functional antibody conjugate containing one FGF21 analog protein and one GLP-1 mimetic peptide.  Strategies directed toward reducing material consumption,  shortening process times, and increasing yields will be discussed.

9:00 Purification Challenges for High-Concentration Monoclonal Antibodies

HongLiHong Li, Ph.D., Principal Scientist, Purification Process Development, Merck

Developing a successful high-concentration formulation of monoclonal antibody for subcutaneous delivery is increasingly desirable. Solubility of the target protein, opalescence, viscosity, and aggregation can result in significant challenges for the manufacturing process. This presentation will focus on the challenges during the development of an Ultrafiltration (UF) step. Developability assessment for target proteins, membrane type system set up for high recovery, and process scale-up are highlighted for discussion.

9:30 Impact of Inclusion Body Quality on Downstream Processing of Novel Biotherapeutic Molecules

TimothyPabstTimothy Pabst, Ph.D., Scientist, Purification Process Science, MedImmune

Refolding of proteins with acceptable yield for the production of therapeutic drug products remains a challenge and requires high quality inclusion bodies. We present an informative case study on the impact of inclusion body quality on product yield and quality by comparing a clinical manufacturing process for a recombinant immunotoxin with the commercial process that was developed to replace it. A systematic approach to commercial process development led to five-fold increase in yield and eliminated fractionation and in-process testing.

10:00 Coffee Break in the Exhibit Hall with Poster Viewing

10:45 Downstream Process for Single Chain Antibody Fragment

AmithNaikAmith Naik, Ph.D., RAC, Senior Scientist, Biomanufacturing Training and Education Center, North Carolina State University

Antibody fragment-based drugs have the high specificity of whole antibody but offer better tissue penetration and less immunogenicity. However, the lack of the Fc region means that the Protein A based platform purification process cannot be employed for antibody-fragments. We present the development of a downstream process for capture and purification of an scFv from bacteria (E. coli) lysate and yeast supernatant. The process comprising of two steps, diafiltration and ion exchange chromatography purified scFv with a purity and recovery of 97% and 90% respectively.

11:15 Enabling Industrial Production of Lentiviral Vectors for Gene Therapy

Michael Kuczewski, Ph.D., Scientist, Purification Process Development, Bluebird Bio

With the approval of the first gene therapy product in the EU and a growing number of advanced clinical trials ongoing, this class of biotherapeutics is finally reaching maturity.  Lentiviral vectors are an ideal platform for indications requiring long-term, stable expression, but the production processes have historically not been scalable.  While many techniques can be borrowed from the world of protein therapeutics, the nature of lentiviral particles poses significant challenges.

11:45 Presentation to be Announced

12:15 End of Conference


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