2008 Regulatory Involvement

  • In March, Raymond Colton, along with fellow representatives of the BPSA Extractables and Leachables Subcommittee, gave a seminar to approximately 50 FDA reviewers and inspectors. The seminar was hosted by FDA-CBER. The risk-based approach to determine extractables and leachables requirements was well received. The methodologies and technical content of the presentations were commended and encouraged by the attendees.

2007 Regulatory Involvement

Validation Resources Publications and Presentations

  • "Extractables and Leachables Evaluations for Filters", Ray Colton and Denise Bestwick, in Filtration and Purification in the Biopharmaceutical Industry (Second Edition), Edited by Maik Jornitz and Theodore Meltzer. New York: Informa Healthcare, USA, Inc., 2008.
  • “Extractables and Leachables from Processing Materials – A BPSA Perspective”, Raymond Colton - Podium Presentation, PDA Extractables Symposium, November 2007
  • “The Effects of Exposure Conditions on the Level of Extractable / Leachable Components”, Poster Presentation, PDA Extractables Symposium, November 2007
  • Bio-Process Systems Alliance, Extractables committee co-chair, Raymond Colton, Primary Author of “Recommendations for Extractables and Leachables Testing” December 2007 / January 2008
  • PDA Extractables Symposium, Raymond Colton - Moderator for Chemistry Sessions, Bethesda, MD, May 2005
  • “Differences in FDA and EMEA Trends and Guidances”, Denise Bestwick, FDA/GMP Compliant Extractables and Leachables Testing, Presentation at Concept Heidelberg, Berlin, Germany, December 2004
  • “Extractables from Filters”, Denise Bestwick, FDA/GMP Compliant Extractables and Leachables Testing, Presentation at Concept Heidelberg, Berlin, Germany, December 2004
  • “Polymer Extractables”, Denise Bestwick, BioPharm Alliance Symposium, Montreal, QC, Canada, June 2004
  • “Maintaining the Validated State”, Raymond Colton - Moderator for FDA/Industry Panel Discussion, PDA SciTech Summit, Orlando, FL, March 2004
  • PDA SciTech Summit, Raymond Colton – Planning Committee, Biopharmaceutical Track, Orlando, FL, March 2004
  • “Filter Extractables”, Raymond Colton, Barnett International Conference on Filtration and Integrity Testing, Philadelphia, PA, June 2003
  • “Bridging the Gap from Science to Compliance”, Raymond Colton – Planning Committee, PDA Spring Meeting, San Diego, CA, March 2003
  • “Current Practices in Aseptic Processing”, Raymond Colton – Member Planning Committee, PDA Spring Meeting, Orlando, FL, March 2002
  • “Study of Protein Adsorption Effects on Crossflow Filtration using BSA and Milk Protein”, Raymond Colton, et al., PDA Journal, January 2002
  • “Extractable Testing for Polymeric Materials in Actual Biopharmaceutical Formulations”, Fang Lu and Raymond Colton, PDA Annual Meeting, Washington, DC, December 2001
  • “Extractable Considerations in Pharmaceutical Processing”, Raymond Colton, PDA Symposium – Extractables – Putting the Pieces Together – Rockville, MD, November 2001
  • “Extractable Measurement Techniques for Actual Pharmaceutical Formulations”, Raymond Colton, PDA Spring Meeting – Las Vegas, NV, March 2001