Using Prior Knowledge and Platform Manufacturing | AIChE

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Using Prior Knowledge and Platform Manufacturing

Conference

Accelerating Biopharmaceutical Development ABD

Year

2013

Proceeding

3rd AccBio / QbD Proceedings

Group

General Submissions

Type

Oral

Room

Salon CD

Location

Coronado Island Mariott

Time

Tuesday, February 26, 2013 - 1:40pm to 3:50pm

Co-chair(s)

Coffman, J., Pfizer, Inc
Bam , N., GlaxoSmithKline

This session will focus on how best to leverage prior process, analytical and formulation knowledge toward acceleration of drug substance and drug product manufacture. The value of clear understanding of the link between process parameters and CQAs will also be explored. Some examples could be minimal or no process development for phase I material, more efficient process and product development and more streamlined process validation.

Presentations

1:45 PM
Accelerating Early Phase Development through Efficient Implementation of Molecular Design and Platform Knowledge
2:15 PM
Increasing Access to the Clinic with a Low Cost, Low Volume Manufacturing Process
2:45 PM
Accelerated Formulation Development for Antibody-Drug Conjugates (ADCs)

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Pricing

Individuals

AIChE Explorer Members $250.00
Non-Members $250.00