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CMC Strategy Forum Summary Papers





 

The purpose of the CMC Strategy Forum is to provide a venue for biotechnology/biological product discussion between industry and regulatory agencies.  The meetings focus on relevant CMC issues throughout the lifecycle of a product and thereby foster collaborative technical and regulatory interactions.  Outcomes of the Forum meetings are published in an appropriate peer-reviewed journal.  It is envisioned that these outcomes will help assure that biopharmaceutical products manufactured in a regulated environment will continue to be safe and efficacious.  The summary papers are listed in alphabetical order.

A Practical Approach to the Analysis and Immunogenic Potential of Aggregates and Particles
Strategy Forun Date/Location: January 9, 2011 Washington, DC
Click here for part one.
Published:  BioProcess International (Volume 9, Number 10, November 2011).
Click here for part two.
Published: BioProcess International (Volume 9, Number 11, December 2011).

Analysis and Structure Characterization of Monoclonal Antibodies
Strategy Forum Date/Location:  January 6, 2003 San Francisco, California
Published:  BioProcess International (Volume 2, Number 2, February 2004).

Analytical Characterization and Regulatory Considerations for Antibody-Drug Conjugates: Uniting Small Molecule and Biologic Drug Perspectives 
Strategy Forum Date/Location: January 24, 2010 Washington, DC
Published: BioProcess International (Volume 9, Number 8, September 2011).

Better Glycosylation Understanding Would Further International Biotech Regulatory Convergence Efforts, CMC Strategy Forum Participants Agree
Strategy Forum Date/Location:  December 3-4, 2012 Tokyo, Japan
Published:  International Pharmaceutical Quality (January 2013)

Binding Assays and Bioassays: What Are Their Roles in Lot Release and Stability Testing?
Strategy Forum Date/Location:  January 28, 2007 Washington, DC
Published:  BioProcess International (Volume 8, Number 6, June 2010).

Biosimilar Products, Guidelines and Requests for Scientific Advice Continue to Increase in EU
Strategy Forum Date/Location: 25-27 May 2010 Vienna, Austria
Published: International Pharmaceutical Quality (August 2010)

Defining Your Product Profile and Maintaining Control Over It: Process-Related Impurities
Strategy Forum Date/Location:  July 19 - 20, 2004 Bethesda, Maryland
Published:  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
Strategy Forum Date/Location:  July 19 - 20, 2004 Bethesda, Maryland
Published:  BioProcess International (Volume 3, Number 6, September 2005).

Defining Your Product Profile and Maintaining Control Over It: Product-Related Impurities
Strategy Forum Date/Location:  July 19 - 20, 2004 Bethesda, Maryland
Published:  BioProcess International (Volume 3, Number 9, October 2005).

Defining Your Product Profile and Maintaining Control Over It: Product-Related Impurities-Tackling Aggregates
Strategy Forum Date/Location:  July 19 - 20, 2004 Bethesda, Maryland
Published:  BioProcess International (Volume 3, Number 10, November 2005).

Drug Product for Biological Medicines: Novel Delivery Devices, Challenging Formulations and Combination Products
Strategy Forum Date/Location: July 16 - 17, 2012 Bethesda, Maryland
Click here for part one.
BioProcess International (Volume 11, Number 4, April 2013).

Demonstrating Comparability for Well-Characterized Biotechnology Products: Early Phase, Late Phase and Post Approval
Strategy Forum Date/Location:  January 9, 2005 Washington, DC
Published:  BioProcess International (Volume 6, Number 2, February 2008).
  
Design and Successful Implementation of a Stability Program for Biotechnology-Derived Products
Strategy Forum Date/Location:  July 25 - 26, 2005 Bethesda, Maryland
Published:  The Gold Sheet (Volume 39, Number 10, October 2005).

EMA's Key Biotech Quality Initiative in Focus at CASSS' 2012 CMC Strategy Forum Europe
Strategy Forum Date/Location: 23-25 April 2012 Berlin, Germany
Published: International Pharmaceutical Quality (May 2012) 

Extractables and Leachables: Challenges and Strategies in Biopharmaceutical Development
Strategy Forum Date/Location:  January 27 - 28, 2008 Washington, DC
Published:  BioProcess International (Volume 9, Number 2, Febuary 2011).

FDA May Ask for More Data on Higher Order Protein Structure in Biotech Applications
Strategy Forum Date/Location:  March 21 - 23, 2011 Barcelona, Spain
Published:  IPQ (May 11, 2011).
  
Glycosylation of Therapeutic Proteins: Current Understanding of Structure-Function Relationship
Strategy Forum Date/Location:  January 28, 2007 Washington, DC
Published:  BioProcess International (Volume 9, Number 6, June 2011).

Increased EMA/Industry Dialogue Needed to Address Upcoming Biopharm Regulatory Challenges , Retiring Quality Director Purves Says
Strategy Forum Date/Location: 25-27 May 2010 Vienna, Austria
Published: International Pharmaceutical Quality (August 2010)

Life Cycle Approach to Setting Specifications for Biotechnology-Derived Products
Strategy Forum Date/Location:  January 5, 2004 Washington, DC
Published:  The Gold Sheet (Volume 38, Number 9, September 2004).

Life Cycle Approach for Specifications 
Strategy Forum Date/Location:  8 - 9 March 2007  Brussels, Belgium
(NOTE: This paper was not published.)
  
Lot Release and Characterization Testing of Live-Virus-Based Vaccine and Gene Therapy Products 
Strategy Forum Date/Location: January 9, 2005 Washington, DC
Click here for part one.
Published:  BioProcess International (Volume 4, Number 4, April 2006).
Click here for part two.
Published: BioProcess International (Volume 4, Number 5, May 2006).

Multiproduct Facility Design and Control for Biologics: Challenges and Considerations
Strategy Forum Date/Location: August 1-2, 2011 Bethesda, Maryland  
Published: BioProcess International (Volume 10, Number 11 (supplement) December 2012).

Mycoplasma In-Process and Lot Release Test: To PCR Or Not To PCR
Strategy Forum Date/Location:  September 19, 2003 Philadelphia, Pennsylvania
Published:  BioProcess International (Volume 3, Number 11, December 2005).

Practical Applications of Quality Risk Management
Strategy Forum Date/Location:  July 27-28, 2009 Bethesda, Maryland
Published:  BioProcess International (Volume 8, Number 3, March 2010).

QbD for Biologics: Learning from the Product Development and Realization (A-MAb) Case Study and the FDA Pilot Program
Strategy Forum Date/Location: July 19-20, 2010 Bethesda, Maryland
Published: BioProcess International (Volume 10, Number 8, September 2012).

Quality by Design (QbD) for Biopharmaceuticals
Strategy Forum Date/Location:  July 16 - 17, 2007 Bethesda, Maryland
Published:  BioProcess International (Volume 7, Number 1, January 2009).

Quality by Design - The Next Phase: Approach for Filing the QbD Data and Potential Regulatory Implications
Strategy Forum Date/Location:  July 24 - 25, 2008 Bethesda, Maryland
Published:  BioProcess International (Volume 7, Number 1, January 2009).

Rapid Pharmaceutical Product Development: Getting Off the Critical Path and Onto the Right Path
Strategy Forum Date/Location: January 22, 2012 San Francisco, California
Published: BioProcess International (Volume 10, Number 11, December 2012)

Raw Material Control Strategies for Bioprocesses
Strategy Forum Date/Location:  January 11, 2009 San Francisco, California
Published:  BioProcess International (Volume 7, Number 8, September 2009).

The Role of Higher Order Structure in Defining the Quality of Biopharmaceutical Products
Strategy Forum Date/Location:  January 24, 2010 Washington, DC
Published:  BioProcess International (Volume 9, Number 4, April 2011).

Standard Reference Materials for Biopharmaceutical Products: Strategies to Support Product and Method Specifications
Strategy Forum Date/Location:  January 23, 2006 San Francisco, California
Published:  The Gold Sheet (Volume 40, Number 6, June 2006).

Strategies to Establish Release Specifications for Peptide Maps
Strategy Forum Date/Location:  September 19, 2002 Boston, Massachusetts
Published:  BioPharm International (Volume 16, Number 4, April 2003).
  
What Is Test Method Qualification?
Strategy Forum Date/Location:  July 24, 2003 Gaithersburg, Maryland
Published:  BioProcess International (Volume 2, Number 8, September 2004).

NOT YET PUBLISHED

January 27, 2008 Washington, DC
Current Practices for Assessing the Comparability and Stability of Gene Therapy Products




 

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5/8/2017 » 5/9/2017
Bioassays 2017

5/22/2017 » 5/24/2017
CMC Strategy Forum Europe 2017

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