Print Page   |   Contact Us   |   Sign In   |   Register
Community Search
Archives - CMC Strategy Forum Summary Papers
Share |

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




 

more Calendar

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

Featured Members
Michelle R. Frazier, Coherus BiosciencesCASSS Associate Director Michelle Frazier is VP for Regulatory Affairs with Coherus.
Julia Edwards, AllerganJulia Edwards is an Executive Director with Allergan.

Membership Software Powered by YourMembership  ::  Legal