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12:20 Opening Address from the Chairman
12:30 E&L Considerations for Adoption of new Single-Use components: A Case Study with Millipak® Final Fill
A successful adoption of single use technology in a Biopharmaceutical process largely relies on the confidence in selection of such materials for the process. Changes to an existing process can be difficult even when there are potential benefits to the change. Considerations include compatibility, functionality and E&L evaluation.
This presentation will evaluate the change control process using an example of the implementation of Millipak® final fill into existing processes. Evaluation of the functional testing and extractables data will be presented. The case study will continue with the risk assessment and patient safety evaluation.
Senior Validation Consultant, Global Support, BioReliance® Validation Services, Merck MilliporeSigma, Portland, Maine, USA
13:00 Questions & Answers
13:10 Top 5 Topics for inclusion in a future ICH document on Extractables and Leachables.
Managing Director, Maven E&L Ltd, Stevenage, United Kingdom
13:40 Questions & Answers
14:00 Minimizing E&L studies.
Pirkko Lahti, Lic Sc (Tech),
Senior Development Manager, Orion Corporation, Tampere, Finland
14:30 Questions & Answers
14:40 BioPhorum (BPOG) Extractable Recommendations for SUS – Final Chapter, and an end user’s data mining experience
Will discuss the new BPOG protocol ver 2.0, and own experience with various extractable data sets, acquired over the years.
Ping Wang, Ph.D., MBA,
Scientific Director, Janssen, Malvern, Pennsylvania, USA
15:30 Questions & Answers
15:50 E&L Studies tailored for Transdermal Delivery Systems
Transdermal patches and related pharmaceutical products have a huge potential for leaching substances from different assembly parts and secondary packaging due to the variety of materials involved. Extractables and leachables (E&L) are unwanted, potentially harmful, substances which could be applied to the patient during medication. The impact of E&L is often underestimated which leads to increased attention of the authorities to this specific topic.
With a focus on complex drug-delivery-products, such as transdermal patches, we look at how E&L studies can be effectively applied to understand how the formulation or sweat of the patient interact with the different materials to ensure a safe medication. Illustrative examples from E&L studies are provided with special attention to an efficient study design which will fulfil the regulatory requirements but not unnecessarily exceed the worst case conditions.
Dr. Tino Otte,
Senior Scientific Consultant, Intertek (Schweiz) AG, Basel-Landschaft, Switzerland
16:20 Questions & Answers
16:30 PQRI Final L&E Recommendations for Parenteral Drug Products and Practical Applications.
Director – Scientific Affairs, West Pharmaceutical Services, Inc., USA
17:00 Questions & Answers
17:10 Panel Discussion
17:50 Questions & Answers
18:00 Closing remarks and end of day one
12:20 Opening Address from the Chairman
12:30 Safety assessment of extractables/leachables: Challenges with ophthalmic administration routes
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.
Dr. Andreas Nixdorf,
Life Sciences - Business Development Manager Extractables & Leachables Testing, SGS Institut Fresenius GmbH, Frankfurt Am Main Area, Germany
13:55 Questions & Answers
14:15 Similarities and differences between medicinal products and medical devices for Extractable and leachable testing.
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.
Vice President Materials & Surface Technologie, Datwyler Pharma Packaging International NV, Limburg, Belgium
15:25 Questions & Answers
15:45 Assessing lot-to-lot variability of single-use devices by Extractables studies - are we hunting ghosts?
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
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
17:15 Controlled extraction of single use Tubing - A Phthalate Case Study.
Key Features of the X500R QTOF System for E&L Analysis:
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.
Director Product Management and Scientific Service, SCHOTT AG, Mitterteich, Germany
18:25 Questions & Answers
18:35 Closing remarks and end of day two
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3P Biopharmaceuticals, ES - Abbott Healthcare Products B.V., NL - Abbvie Deutschland GmbH & Co. KG, DE - Accord-UK Ltd, UK - Advent Consulting Canada, CA - ALK, DK - Alkermes Pharma Ireland Limited, IE - Alphamed Formulations PVT LTD, IN - Apotex Research Pvt Ltd., IN - Aspen Holdings, ZA - Aspen Pharmacare, ZA - B.Braun medical SA, CH - Bavarian Nordic, DK - Becton Dickinson, CN - Becton Dickinson, FR - Biogen, USA - Boston Analytical, USA - Claudia Cusa, d.i., IT - CSL Behring AG, CH - Datwyler Pharma Packaging International NV, BE - DuPont, USA - DuPont-Asahi Flash Spun Products, JP - EirGen Pharma, IE - Eli Lilly and Company, USA - EMS SA, CH - Eurofins Analytical Science Laboratories, Inc., JP - Fujifilm Diosynth Biotechnologies, UK - GSK, US - GSK Vaccines, BE - Hall Analytical, UK - Hemofarm AD, RS - HTL-Strefa S.A., PL - Intertek (Schweiz) AG, CH - Janssen, USA - Kora Healthcare, IE - LEO Pharma, IE - Maven E&L Ltd, UK - Medline Industries, USA - Merck KGaA, DE - MilliporeSigma a business of Merck KGaA, USA - Novartis, CH - Novartis Pharma Stein AG, CH - NOVAVAX CZ a.s., CZ - Orexo AB, SE - Orion Corporation - FI, Philips, NL - Polifarma İlaç San. ve Tic. A.Ş., TR - PPD, IE - Rentschler Biopharma SE, DE - Safetree Consulting e.U., AT - Sandoz Manufacturing Inc., CA - Sanofi, FR - Sanofi, DE - Sanofi Pasteur, CA - Sartorius Stedim Biotech GmbH, DE - SCHOTT AG, DE - SCIEX, UK - Selvita S.A., PL - Septodont, FR - SGS, CN-TW - SGS Institut Fresenius GmbH, DE - Solvias AG, CH - Sthree, BE - Swedish Biomimetics 3000 Ltd, UK - Takeda Pharmaceuticals, USA - Vet-Agro Sp. z o.o., PL - West Pharmaceutical Services, USA - Wockhardt Ltd, IN - and others.
AbbVie - AiCuris Anti-infective Cures GmbH - Angelini ACRAF s.p.a. - B. Braun - Bayer - Bayer AG - Borealis Polymere GmbH - Brooks Life Sciences - Claudia Heldt - Daicel Chiral Technologies (India) Pvt Ltd - Datwyler Pharma Packaging International NV - Datwyler Sealing Solutions - EirGen Pharma - Engelhard Arzneimittel GmbH & Co KG - F. Hoffmann-La Roche Ltd - GSK - GSK Vaccines - Hall Analytical Laboratories Limited - HTL-Strefa S.A. - Intertek (Schweiz) AG - Iterum Therapeutics - Lyomark Pharma GmbH - Maven E&L Ltd - Medichem - Merck - Merck KGaA - Nelson Labs - Novartis Institutes for BioMedical Research - Novo Nordisk - Pall Biotech - Patheon, by Thermo Fisher Scientific - PHARMIDEA SIA - Purus Plastics - RMS Foundation - Safetree Consulting e.U. - Sandoz - Sanofi - Sanquin Plasma Products - Sartorius Stedim Biotech - SAS Laboratoire Aguettant - SCHOTT AG - SE Tylose GmbH & Co. KG - SGS Institut Fresenius GmbH - Smithers Rapra Ltd. - Synthon Biopharmaceuticals BV - Vifor (International) AG - West Pharmaceutical Services GmbH & Co. KG - ZETA GmbH - Others