TUESDAY SEPTEMBER 22, 2020 9:00-12pm
The Process of CMO Selection for Bispecific Antibody Development: Matching Capabilities to Need
Financing realities of biotech start-ups require that companies outsource the development, scale-up and manufacture of therapeutic bispecific antibodies that are to be tested clinically. This is a substantial undertaking, both in terms of time and investment. In working with a small company client to evaluate, select and manage a CDMO to produce a recombinant bispecific antibody expressed in CHO cells, Steven navigated to a successful outcome for the clinical Phase 1 program by matching the CDMO’s capabilities to the company’s needs. Challenges in subcontracting biologics cell line development and production will be discussed.
Steven Chamow will examine the best methods necessary to select the relevant CMDO for Bispecific Antibody Development. CMO’s have expertise, and capabilities should be evaluated carefully.
By attending this workshop, you will learn:
• How to match ability to requirement
• Override challenge with client company and project
• Overcome constraints.
• The importance of the match
• To understand the considerations for candidate CMOs.
• The scope of work, including, development, GMP production and timing of pre-IND meeting and IND
• How a CMO can design a production process and provide high quality product
• To meet regulatory requirements in enough quantity.
If you are looking to develop a new biologic for clinical testing and plan on outsourcing manufacturing to a competent CMO, this is the perfect workshop for you.
Steven M. Chamow
Chamow & Associates Inc.