Extractables and Leachables - Scientific Expertise l VR Analytical

Professional Accomplishments

A select summary of posters, presentations and publications authored by VR Analytical staff. If you are interested in discussing a project please email us. 

  • “Comparison of BPOG and USP Test Matrixes for a Hydrophilic PES Capsule Filter,” Raymond Colton and Sarah Brophy. Presented at the USP Biocompatibility and Material Characterization Workshop, Rockville MD, June 2016.

  •  “Proposal for the Standardization of Analytical Methods for Extractables Testing,” Raymond Colton, Sarah Brophy, and Jon Hopper.  Presented at the Extractables, Leachables and Elemental Impurities Conference, PharmEd, La Jolla, CA April 2016.
  • "The Use of TOC Reconciliation as a Means of Establishing the Degree to Which Chromatographic Screening of Plastic Material Extracts for Organic Extractables is Complete," Dennis Jenke and Thomas R. Couch of Baxter Healthcare Corporation, and Sarah J. Robinson, Trent J. Volz and Raymond H. Colton of VR Analytical. Article published in PDA Journal of Pharmaceutical Science and Technology; PDA J Pharm Sci and Tech 2014, 68 256-270. 

  • "Designing Analytical Method Strategies Based on Test Article Materials of Construction and Total Organic Carbon (TOC) Reconcilation," presented by Sarah J. Robinson at Smithers Rapra Extractables and Leachables USA, May 7-9, 2014.

  • “An Integrated Systems Approach to Identifying Extractables from Single Use Materials: Closing the Gap on Total Organic Content,” Dr. Sarah Robinson, et al.; Poster Presentation at ASMS 61st Conference on Mass Spectrometry and Allied Topics, Minneapolis, MN, June 2013

  • “The Chem-Tox Partnership – Why One Needs the Other to Succeed in E&L Assessments," Dr. Sarah Robinson and Dr. Rick Pleus; Podium Presentation at Sartorius Stedim Biotech Extractables/Leachables Forum, San Diego, CA, May 2013.

  • "Introduction to Extractables and Leachables," Denise Bestwick and Lisa Buan; Podium Presentation at Sartorius Stedim Biotech Extractables/Leachables Forum, San Diego, CA, May 2013.

  • “Reconciliation of TOC," Raymond Colton. Podium Presentation at Sartorius Stedim Biotech Extractables/Leachables Forum, Boston, MA, Sep 2012.
  • “Extractables and Leachables – Back To Basics," Denise Bestwick; Podium Presentation at Sartorius Stedim Biotech Extractables/Leachables Forum, Boston, MA, Sep 2012.
  • “Effect of Ethanol Concentration on Extractables from Bags, Tubing and Filters," Raymond Colton; Podium Presentation at Sartorius Stedim Biotech Extractables/Leachables Forum, Goettingen, Germany, May 2011.
  • “Orthogonal Approach to Leachables Testing,” Raymond Colton; Podium Presentation at Sartorius Stedim Biotech Extractables/Leachables Forum 2010, Goettingen Germany, June 2010.
  • “Survey of Extraction Techniques and Conditions,” Denise Bestwick; Podium Presentation at Sartorius Stedim Biotech Extractables/Leachables Forum 2010, Goettingen Germany, June 2010.
  • “Extractables and Leachables from Single-Use Disposables," Denise Bestwick and Raymond Colton; Article for BioProcess International, Volume 7, Supplement 1, Biomanufacturing: The Age of Disposables.
  • Extractables and Leachables Evaluations For Filters," Raymond Colton and Denise Bestwick; Chapter for Filtration and Purification in the Biopharmaceutical Industry, 2nd Edition, 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," Adriana Gonzalez-Gray, et al.; Poster Presentation, PDA Extractables Symposium, November 2007.
  • PDA Extractables and Leachables Symposium, Denise Bestwick, Planning Committee Member, November 2007.
  • Bio-Process Systems Alliance, Extractables Committee Co-chair, Raymond Colton, Primary Author of “White Paper” published in Bio-Pharm, December 2007.
  • PDA Extractables Symposium, Raymond Colton, Moderator for Chemistry Sessions, Bethesda, MD, May 2005.
  • “Differences in FDA and EMEA Trends and Guidances," Denise Bestwick; Podium Presentation, FDA/GMP Compliant Extractables and Leachables Testing, Concept Heidelberg, Berlin, Germany, December 2004.
  • “Extractables from Filters," Denise Bestwick; Podium Presentation, FDA/GMP Compliant Extractables and Leachables Testing, Concept Heidelberg, Berlin, Germany, December 2004.