CMC Strategy Forum 2007

Introduction

Final Program Schedule

Preliminary Program Schedule

Organizing Committee

Sponsors

Online Registration Center

Hotel Information

Travel Center

Conference History

Position Papers

For More Information

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CMC Strategy Forum Final Program is now available.

Europe

March 8-9, 2007 Brussels, Belgium

Life Cycle Approach for Specifications

United States

CMC Position Papers

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
The summary review has been published in The Gold Sheet (Volume 38, Number 9, February 2004).

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
The summary review has been published in The Gold Sheet (Volume 39, Number 10, October 2005).

January 23, 2006

Standard Reference Materials for Biopharmaceutical Products: Strategies to Support Product and Method Specifications
The summary review has been published in The Gold Sheet (Volume 40, Number 6, June 2006).

July 20 – 21, 2006

Changing the Paradigm of Process Validation

January 28, 2007

Binding Assays and Bioassays: What Are Their Roles in Lot Release and Stability Testing?
Glycosylation of Therapeutic Proteins: Current Understanding of Structure-Function Relationship

July 16, 2007

CMC Strategy Forum

 

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

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