2nd Annual Extractables & Leachables Summit 2020

Tentative Schedule:

12:00 Registration

12:20 Opening Address from the Chairman

12:30 Safety assessment of extractables/leachables: Challenges with ophthalmic administration routes

• General safety considerations for the safety assessment of extractables/leachables (E&L) in pharmaceutical products will be summarized
• Current safety thresholds applicable to E&L in pharmaceutical products will be introduced
• Specific safety considerations and approaches for E&L in ophthalmic products will be discussed

Dr. Christian Trendelenburg,
Associate Director, Novartis, Basel, Switzerland

13:00 Questions & Answers

13:10 Leachable Study design Space in Complex formulated Drug Products such as Biopharmaceuticals.

• Assessment factors that must be presented to the authority through the leachable study design
• Assessment Robustness: Matrix Impacts, Large Volume problem and others
• Strategic elements that can be incorporated into the study design: Simulation, Negative Controls, Aging Controls

Dr. Andreas Nixdorf,
Life Sciences - Business Development Manager Extractables & Leachables Testing, SGS Institut Fresenius GmbH, Frankfurt Am Main Area, Germany

13:55 Questions & Answers

14:05 Break

14:15 Similarities and differences between medicinal products and medical devices for Extractable and leachable testing.

• What are Medical devices and Medical products Regulatory expectations
• Similarities and differences between medicinal products and medical devices for Extractable and leachable testing

Andrew Feilden,
Director Analytical Sciences, Bicycle Therapeutics, Shawbury, United Kingdom

14:45 Questions & Answers

14:55 The effect of X-ray and ClO2 sterilization techniques on Extractables & Leachables of Rubber Closures.

• A comprehensive overview of different sterilization techniques for rubber closures
• The effect of classic sterilization techniques (Steam, Gamma irradiation and EtO) on E&L
• The impact of X-ray on E&L as alternative to Gamma sterilization
• The impact of ClO2 on E&L as alternative to EtO sterilization

Bram Jongen,
Vice President Materials & Surface Technologie, Datwyler Pharma Packaging International NV, Limburg, Belgium

15:25 Questions & Answers

15:35 Break

15:45 Assessing lot-to-lot variability of single-use devices by Extractables studies - are we hunting ghosts?

• Potentials and limits of analytical screening methods to reveal lot-to-lot differences of SUS
• Factors leading to inconsistent extractables results
• Results of a SUS bag film material investigation, repeatability and lot-to-lot variance
• Insight into SU supplier Extractables testing strategies

Dr. Roberto Menzel,
Laboratory Supervisor and Manager Extractables, Sartorius Stedim Biotech, Göttingen, Germany

16:15 Questions & Answers

16:25 Analytical strategies for extractables and leachables

• Analytical technique selection
• Challenges of coverage of E&L
• Perspective on E&L analysis

Tom van Wijk,
Principal Scientist, Analytical Science and Technology Team lead Pharmaceutical analysis, Abbott Healthcare Products B.V., Weesp, The Netherlands

16:55 Questions & Answers

17:05 Break

17:15 Controlled extraction of single use Tubing - A Phthalate Case Study.

Key Features of the X500R QTOF System for E&L Analysis:

• Sensitive, fast scanning, benchtop hybrid quadrupole time of flight mass spectrometer
• SWATH acquisition enabled for the most comprehensive data independent analysis
• Retention time alignment deconvolution when processing the data provides clean spectra that can be used for structure elucidation or library searching
• Richly featured, user friendly, SCIEX OS software for acquisition and data processing for quantitative and qualitative workflows
• Extractable and Leachable focused NIST subset library of industry standard spectra and compounds that is user customizable

Neil Devenport,
Snr Support Small Molecule Quantitation & Identification, SCIEX, Mitterteich, Germany

17:45 Questions & Answers

17:55 Influencing factors on Extractables and Leachables at different glass materials.

As the complexity of modern drug products grows from a chemical and physical point of view, the evaluation of possible drug/container interactions are an increasing focus area in primary packaging material development. These interactions mainly depend on several factors: the chemical composition of the glass packaging material, the conversion process (namely the transformation of glass tubing into containers), possible additional surface treatments and, finally, the drug product itself. Regarding the first aspect, the composition of glass varies among different glass types as well as among different manufacturers. In consequence, the composition of a glass gives first indications for potential sources of extractables. A case study will be presented revealing differences in the extractables levels among different glass types, such as borosilicate glass and aluminosilicate glass. Furthermore, also the influence of the conversion process and possible surface treatments on the chemical stability of both glass types will be illustrated.

Folker Steden,
Director Product Management and Scientific Service, SCHOTT AG, Mitterteich, Germany

18:25 Questions & Answers

18:35 Closing remarks and end of day two