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CMC Position Papers  

Introduction

We are pleased to announce the creation of the WCBP CMC Strategy Forum, A Section of the California Separation Science Society (CASSS). The objective of the WCBP CMC Strategy Forum is to provide an environment for the development of technical and regulatory consensus positions regarding topics of interest to WCBP. Consensus positions regarding topics of interest to the WCBP will be communicated to the FDA and Industry through appropriate mechanisms (e.g., publications). The WCBP CMC Strategy Forum is intended to:

• Establish a biotechnology industry forum that focuses on industry and FDA CMC concerns identified at the annual WCBP meeting.

• Foster collaborative technical and regulatory interactions that advance discussions to consensus concepts for our mutual benefit.

• Provide this information to the FDA to allow them to merge good scientific practices with good regulatory practices.

• Further examine the technical and regulatory issues raised at the WCBP meeting and develop plans to address them.

The Forum will also provide a venue for discussing the latest bio-molecular methods and their practical application to biotechnology pharmaceuticals and other health related products. This includes both method and instrumental advances that are used for product characterization, process development, and validated in-process, release and stability tests.

To provide adequate opportunity for FDA and Industry involvement, one two-day meeting will be conducted annually and will be held in Bethesda, Maryland at Lister Hill Auditorium on the NIH Campus. Two parallel Forums will be held in conjunction with WCBP annually. Each meeting will focus on a CMC related issues such as product characterization, comparability, specifications, etc. The format of each meeting will consist of case studies and presentations by Industry and/or FDA experts to introduce the topic and the key issues of concern. Breakout sessions will then be conducted to allow for additional discussion on the technical and regulatory details of the topics. It is envisioned that the final outcome of the workshop discussions will be the development of a document to be submitted to the appropriate FDA designees for their consideration in developing and/or clarifying good regulatory practice guidelines for biotechnology derived products.

September 19, 2002

Strategies to Establish Release Specifications for Peptide Maps
The summary paper has been published in BioPharm International (Volume 16, Number 4, April 2003).

January 6, 2003

Analysis and Structure Characterization of Monoclonal Antibodies
The summary paper has been published in BioProcess International (Volume 2, Number 2, February 2004).

July 24, 2003

What Is Test Method Qualification?
The summary paper has been published in BioProcess International (Volume 2, Number 8, September 2004).

September 19, 2003

Mycoplasma In-Process and Lot Release Test: To PCR Or Not To PCR
The summary paper has been published in BioProcess International (Volume 3, Number 11, December 2005).

January 5, 2004

Life Cycle Approach to Setting Specifications for Biotechnology-Derived Products

July 19 – 20, 2004

Defining Your Product Profile and Maintaining Control Over It: Process-Related Impurities
The summary paper has been published in BioProcess International (Volume 3, Number 6, June 2005).

Defining Your Product Profile and Maintaining Control Over It: The Challenges of Monitoring Host Cell Protein Impurities
The summary paper has been published in BioProcess International (Volume 3, Number 8, September 2005).

Defining Your Product Profile and Maintaining Control Over It: Product-Related Impurities
The summary paper has been published in BioProcess International (Volume 3, Number 9, October 2005).

Defining Your Product Profile and Maintaining Control Over It: Product-Related Impurities – Tackling Aggregates
The summary paper has been published in BioProcess International (Volume 3, Number 10, November 2005).

January 9, 2005

Demonstrating Comparability for Well-Characterized Biotechnology Products: Early Phase, Late Phase and Post Approval

Lot Release and Characterization Testing of Live Virus-Based Vaccine and Gene Therapy Products
The part one summary paper has been published in BioProcess International (Volume 4, Number 4, April 2006).
The part two summary paper has been published in BioProcess International (Volume 4, Number 5, May 2006).

July 25 – 26, 2005

Design and Successful Implementation of a Stability Program for Biotechnology-Derived Products

January 23, 2006

Standard Reference Materials for Biopharmaceutical Products: Strategies to Support Product and Method Specifications

July 20 – 21, 2006

Changing the Paradigm of Process Validation