Publications

  1. Evaluating the Toxicity of bDtBPP on CHO-K1 Cells for Testing of Single-Use Bioprocessing Systems Considering Media Selection, Cell Culture Volume, Mixing, and Exposure Duration

  2. Head-to-head “Standard” Extractables Comparison; Generating data to drive the industry

  3. Extractables Evaluation of a Single-Use Bioprocess Bag According to Published Recommendations

  4. Extractables Evaluation of a Commercially Available Single-Use Bioprocess Film in Accordance with Published Recommendations and Industry Best Practices

  5. Extractables Study for Single-Use Components: Sensors and Sensor Bodies

  6. Extractables/Simulation Study for Single Use System: Bioreactor Bag

  7. Extractable Method for the Determination of Nitrosamines in Pharmaceutical Elastomers

  8. Extractables Evaluation of Single-use Systems: The Role of Material Suppliers

  9. Extractables Isolated from Two Competitor Pt Cured Silicone Tubing Materials: A Comparative Study

  10. From Initial Characterization to Chromatographic Method Development: Chapter 1 – Primary Methods of Characterization

  11. From Initial Characterization to Chromatographic Method Development: Chapter 2 – Chromatographic and Detection Decisions for Early Method Development

  12. From Initial Characterization to Chromatographic Method Development: Chapter 3 – Validation of a Potency Method by ICH Guidelines

  13. Extractables & Leachables in Medical Devices: How Much Testing Is Adequate?

  14. Extractables & Leachables in Single-Use Systems for Bioprocessing: What Is Adequate Testing?

  15. Inhalation Products: What Is Adequate Testing?

  16. Extractable Nitrosamines: Comparison of GC/NCD versus GC/MS/MS for the Analysis of Elastomers

  17. Extractables Isolated from Two Competitor Butyl Rubber Stoppers: A Comparative Study

  18. Validation of a GC/HS/NPD Method Suitable for Determination of Acrylonitrile as a Leachable in an Aqueous Based Nasal Spray

  19. Synthesis of Fatty Alcohol Esters of α -Hydroxy Carboxylic Acids via Enzymatic Transesterification

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