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 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.
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 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 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