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