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August 22-23, 2013

Cambridge Healthtech Institute’s Inaugural
Early IND Strategies: Process and Production

Preclinical Process Development to Support Regulatory Filings, Toxicology and Clinical Supply


Day 1 | Day 2 | Short Courses | Download Brochure 

Thursday, August 22, 2013

1:55 pm Chairperson’s Remarks

Susan Dana Jones, Ph.D., Vice President and Senior Consultant, BioProcess Technology Consultants, Inc.


2:00 Keynote Presentation

Developing Products for Rare Diseases: Strategies for Early Phase Process Development

Joanne BeckJoanne Beck, Ph.D., Vice President, Process Development, Shire Human Genetic Therapies

Early clinical development for rare diseases follows an accelerated path rather than the traditional development path of consecutive Phase I, II and III clinical trials. This presentation will focus on process development strategies implemented to deal with challenges specific to early drug development for rare diseases. The complexity of the products, the inability to rely on highly productive production and analytical platforms, the small number of clinical batches, and accelerated development timelines demand that we understand the relationship between drug structure, function, and manufacturing process from early on and continue to learn even after the products have gained market approval.


Case Studies of Early Process Development 

2:30 Using Early Material Generation to Assess Manufacturability of Biologic Candidates

Jennitte Stevens, Ph.D., Principal Scientist, Therapeutic Discovery, Biologics, Amgen

Understanding potential manufacturing issues early on in the candidate selection process can help eliminate candidates that will present issues in cell line and process development downstream. I will discuss the use of transient and CHO pool material to gain early insight into manufacturability of different types of biologics (antibody and non-antibody molecules as well as bispecfics), and what quality attributes can and cannot be predicted from these expression systems.

3:00 Early Process Development and Clinical Production of an IL-1 Therapeutic Inhibitor

Kathryn Golden, MS, Scientist II, Protein Production and Analytics, Eleven Biotherapeutics

Early fermentation and purification process development efforts of an IL-1 therapeutic inhibitor were aimed at reducing the levels of product related species in the final drug substance. The processes were transferred to a contract manufacturing organization and used to produce material for toxicology and clinical trials in dry eye disease. Further process improvements were implemented for Phase 2 production by combining in-house process development efforts, technology transfer and effective management of CROs and CMOs. Various strategies and techniques were utilized to ensure rapid and successful timelines from molecule selection to an IND filing and the clinic.

3:30 Refreshment Break in the Exhibit Hall with Poster Viewing

4:15 Engineering Product Quality into Early Development Activities

Susan Dana JonesSusan Dana Jones, Ph.D., Vice President and Senior Consultant, BioProcess Technology Consultants, Inc.

Generating a quality target product profile (TPP) before initiating product development is an effective way insure that the product performs as intended. Glycosylation, multimer formation, or other quality attributes defined in the TPP can be selected for at all stages of early development. This talk will present two case studies in which target quality attributes for a new biopharmaceutical product were used to drive final candidate selection during discovery or final clone selection in early development.

4:45 Evaluation of Upstream Cell Density Control Strategies for a Continuous Biopharmaceutical Manufacturing Process

Seul BaeSeul Bae, Process Engineer, Genzyme Corporation

Genzyme has pioneered the development of an integrated continuous biopharmaceutical manufacturing platform for the universal production of protein therapeutics. We will present on various online cell mass and metabolic measurements for robust cell density control of high cell density cultures to achieve steady-state productivity and product quality. We will also discuss the universality of the platform for the production of a broad array of protein therapeutics.

5:15 End of Conference Day & Registration for Dinner Short Course

6:00 Dinner Short Course*

9:00 Close of Day


*Separate registration required



Day 1 | Day 2 | Short Courses | Download Brochure