Extractables & Leachables Summit 2019

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NH Collection Berlin Friedrichstrasse

Friedrichstraße 96

10117 Berlin

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Our website: Extractables & Leachables Summit 2019

We are honored to invite you to participate in the Extractables & Leachables Summit 2019, happening on 15-16 October 2019.

Venue: NH Collection Berlin Friedrichstrasse,
Friedrichstraße 96, 10117 Berlin, Germany.

SPEAKING SPONSOR: - Intertek (Schweiz) AG

BRONZE SPONSOR: - SGS Institut Fresenius GmbH

Register early to save €300 for the Individual ticket, €400 per person for 2-3 Delegates, €600 per person for 4+ delegates from the same company until 16 August 2019.

CONFERENCE OVERVIEW:

Extractables & Leachables Summit 2019 is a 2-day event concentrating on the latest updates in regulation, analytical testing, risk & safety assessment, biocompatibility.

The featured talks on:

  • USP draft standard: A rational risk-based approach to characterization of polymeric biopharmaceutical manufacturing systems.
  • Strategies for assessment of impurities and E&Ls.
  • Safety assessment of extractables/leachables: Challenges with different administration routes.
  • Toxicological assessment of non-genotoxic E&L.
  • Challenges and pitfalls during E&L studies and how to handle them.
  • Setting up effective E & L Studies: extraction and right conditions selection, leachable study monitoring and compounds selection, leachable study design.
  • Comparative Extractables Study of Autoclavable Polyethersulfone Filter Cartridges for Sterile Filtration.
  • Data Integrity.
  • Extractables and Leachables challenges of for prefilled syringes.
  • The rubber formulation composition and its impact on extractables and leachables.
  • Leachables strategies for finished biopharmaceuticals.
  • Adoption of standardized extractables datasets for single-use system qualification and risk assessment.

SPEAKERS BOARD:
  • Bram Jongen | Head of R&D, PPS | Datwyler Pharma Packaging International NV, BE
  • Andrew Feilden | Technical director | Smithers Rapra Ltd., UK
  • Dr. Tino Otte | Senior Scientific Consultant | Intertek (Schweiz) AG, CH
  • Prof. Dr. Johannes Harleman | Former Vice-President Global Preclinical Development & Management | Fresenius Kabi Deutschland GmbH, DE
  • Carsten Worsøe | Principal Scientist | Novo Nordisk A/S, DK
  • Dr. Christian Trendelenburg | Senior Toxicologist & Project Leader (PTM) | Novartis,, CH
  • Dr. Roberto Menzel | Laboratory Supervisor and Manager Extractables | Sartorius Stedim Biotech, DE
  • Dr. Clemens Günther | Director Nonclinical Safety Consumer Care | Bayer AG, DE
  • Dr. Andreas Nixdorf | Life Sciences - Business Development Manager Extractables & Leachables Testing | SGS Institut Fresenius GmbH, DE
  • Dr. Simone Biel | Field Marketing Single Use Technology | Merck Millipore, DE
  • Dr. Gilbert Tumambac | Sr. Principal Scientist | Pall Biotech, USA
  • Rick Reiley | Principal Scientist | GlaxoSmithKline, UK
  • Dr. Bettine Boltres | Principal Scientific Affairs, Packaging & Delivery Systems | West Pharmaceutical Services Deutschland GmbH & Co KG, UK

CONFERENCE PROGRAMME:

Day 1st | Tuesday, 15 October 2019

07:50 - Registration and Welcome Coffee

08:30 - Opening Address from the Chairman

08:40 - USP draft standard: A rational risk-based approach to characterization of polymeric biopharmaceutical manufacturing systems.

USP draft will be the first standard for characterization of specifically single-use systems (SUS) used in manufacturing. In this session we will discuss:

  • Risk assessment with respect to patient safety to assign a risk level
  • Risk level appropriate testing of components
  • Approach for compliance for filters and SUS from a SUS supplier’s perspective

Dr. Simone Biel
Field Marketing Single Use Technology - Merck Millipore, DE

09:20 - Speed ​​Networking

10:00 - Strategies for assessment of impurities and E&Ls.

  • Definitions of E&L and impurities
  • Qualification thresholds
  • Use of QSAR
  • Role of API in assessment
  • Experience with regulators on PQRI proposals

Prof. Dr. Johannes Harleman,
Former Vice-President Global Preclinical Development & Management - Fresenius Kabi Deutschland GmbH, DE

10:40 - Morning coffee and networking break

11:10 - Safety assessment of extractables/leachables: Challenges with different administration routes.

  • Safety thresholds for extractables/leachables in pharmaceutical products will be introduced
  • Applicability of these thresholds to products for different administration routes will be discussed
  • Specific safety considerations and approaches for parenteral and ophthalmic products are summarized

Dr. Christian Trendelenburg,
Senior Toxicologist & Project Leader (PTM) - Novartis, CH

11:40 - Toxicological assessment of non-genotoxic E&L.

  • Regulatory Guidance
  • Searching for toxicological information
  • No data available - The Threshold of Toxicological Concern (TTC) approach
  • Point of departure available - How to define the Permitted Daily Exposure

Dr. Clemens Günther,
Director Nonclinical Safety Consumer Care - Bayer AG, DE

12:20 - Challenges and pitfalls during E&L studies and how to handle them

For patient safety reasons a precise knowledge about potential drug impurities is essential. With increasing complexity of container closure systems and single use process equipment the risk of leachables being introduced as real drug impurities increases significantly. Authorities are extensively focusing on determination of leachables present in the real drug matrix which increases the analytical effort and complicates data interpretation. According to general guidelines the E&L studies are commonly divided into different parts:

  • Screening of containers and process equipment for extractables
  • Screening of the formulation stored under accelerated conditions for potential leachables
  • Tox-assessment and definition of the target leachables and their specification
  • Leachables method validation
  • GMP monitoring of leachables during a stability study in real samples

During this presentation we will focus on the problems which may occur when extractables or leachables above the analytical evaluation threshold are detected during the different steps. Several case studies will be presented. Content:

  • Illustration of a suitable study design covering production process, filling line and final container closure system
  • Extractables of multi-material-equipment and how to clarify their source
  • Temporary leachables detected during stability study
  • Unknown leachables and how to identify them

Dr. Tino Otte,
Senior Scientific Consultant - Intertek (Schweiz) AG, CH

12:45 - Business lunch

13:45 - RESERVED FOR SPONSOR

14:10 - Setting up effective E & L Studies: extraction and right conditions selection, leachable study monitoring and compounds selection, leachable study design.

Andrew Feilden,
Technical director - Smithers Rapra Ltd., UK

14:50 - Comparative Extractables Study of Autoclavable Polyethersulfone Filter Cartridges for Sterile Filtration.

Dr. Roberto Menzel
Laboratory Supervisor and Manager Extractables - Sartorius Stedim Biotech, DE

15:30 - Afternoon coffee and networking break

16:00 - Data Integrity.

Rick Reiley,
Principal Scientist - GlaxoSmithKline, UK

16:40 - Session 10.

  • Building effective leachables study: mapping activities for the development phase, techniques for the quality control, information identification and effective use. OR
  • Excelling leachables strategies: analytical methods and validation, strategy development, chemical profiles. Single-use process equipment. Risk-based evaluation.
  • Extractables testing: criteria for the profile, quality control, change management. OR
  • Setting up effective E & L Studies: extraction and right conditions selection, leachable study monitoring and compounds selection, leachable study design.

17:20 - Panel Discussion

17:50 - Chairman's closing remarks and end of day one

19:00 - Business dinner

Day 2nd | Wednesday, 16 October 2019

08:00 - Registration and Welcome Coffee

08:30 - Opening Address from the Chairman

08:40 - Extractables and Leachables challenges of for prefilled syringes.

  • Critical E&L related components in prefilled syringes
  • Relationship between extractables, simulated leachables and leachables
  • What is the optimal tool to predict leachables in a prefilled syringe?
  • Case studies on simulated studies in prefilled syringes

Carsten Worsøe,
Principal Scientist - Novo Nordisk A/S, DK

09:20 - Session 2.

  • Medical device: E & L point of view, regulatory updates, packaging, testing. OR
  • Large volume injections: E & L testing challenges, primary and secondary packaging.

10:00 - Morning coffee and networking break

10:30 - The rubber formulation composition and its impact on extractables and leachables.

  • Composition of Rubber for Parenteral Packaging
  • Different rubber formulations geared towards specific properties
  • The evolution of rubber formulation cleanliness throughout the years
  • Expectations of Extractables information sharing from a rubber closure supplier

Bram Jongen,
Head of R&D, PPS - Datwyler Pharma Packaging International NV, BE

11:10 - Leachables strategies for finished biopharmaceuticals.

Extractables and leachables are product-related impurities that result from product contact with components such as gaskets, stoppers, storage bags, cartridges, and prefilled syringes that are used for processing, storage, and/or delivery of biopharmaceuticals. Leachables are of concern for patients due to potential effects on product quality and safety. It is possible that such an impurity could directly impact the patient or indirectly impact the patient by interacting with the protein by chemical reactions. Adducts and leachables may or may not be detected as product-related impurities in leachables screening stability studies depending on the rigor of the analytical program. The need for the development of a thorough and holistic extractable and leachable program based on risk assessment, review of existing literature, and consolidation of industry best practices is discussed. Risk mitigation strategies for an extractable-leachable program must be divided into different stages. The integration of analytical activities with health-based risk-assessment information into the design of an extractable-leachable program is highlighted.

Dr. Andreas Nixdorf,
Life Sciences - Business Development Manager Extractables & Leachables Testing - SGS Institut Fresenius GmbH, DE

12:00 - Business lunch

13:00 - Session - RESERVED.

Dr. Bettine Boltres,
Principal Scientific Affairs, Packaging & Delivery Systems - West Pharmaceutical Services Deutschland GmbH & Co KG, BE

13:40 - Adoption of standardized extractables datasets for single-use system qualification and risk assessment.

  • Implementation of USP and alignment with BPOG extractables protocol
  • Insights from the execution of both the BPOG and USP extractables protocols on various single-use components (biocontainer, filter, sterile connector, tubing)
  • Examples of extractables datasets generated per BPOG and USP extractables protocols
  • Case studies illustrating how component extractables data are applied for risk assessment of potential leachables from single-use system
  • Toxicological risk assessment of potential leachables from SUS

Dr. Gilbert Tumambac,
Sr. Principal Scientist - Pall Biotech, USA

14:20 - Afternoon coffee and networking break

14:50 - Session 7.

  • Extractables & Glass: extractables types, glass composition, risk evaluation, extractables minimalization strategies. Challenges related to glass use in parenterals. OR
  • Extractables & Plastics: plastics and additives classification and types, chemical and physical characteristics. OR
  • CCS & materials: practical examples of use of different types of polymers. Polymers composition.

15:30 - Session 8.

  • Extractables & Elastomers in parenteral packaging: elastomers composition, E & L minimalization, E & L studies for parenterals. OR
  • Leachables in biopharmaceuticals: leachables role in the manufacturing process, influence on the stability, storage and administration. Bioproduction view on the E&L evaluation: practical examples. Materials approaches. OR
  • Lyophilized products: primary packaging, leachable studies design and evaluation. Regulations impact on combinations products in administration procedures: 21CFR Part 4.

16:10 - Chairman's closing remarks and end of the summit

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10117 Berlin

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