Extractable Study on a COP Polymer Pre-Filled Syringe
Sponsored by: Terumo Pharmaceutical Solutions & Toxikon Europe
- Pre Filled Syringes
- Polymer Syringes
Date: 19 April
Time: 3PM Berlin/2PM London/9AM New York
PLAJEX™ ready-to-fill polymer syringes with a focus on biotherapeutics
The new era of biotherapeutics has prompted the parenteral drug development business into a changing injectable landscape due to the physical and chemical sensitivity of these drug products. In particular, Pre-Fillable Syringes are more likely to induce interactions that could affect immunogenicity and product safety.
The pharma industry has a responsibility to ensure the safety and efficacy of its drugs; therefore, it is necessary to assess each step of development, from raw materials to the final product. It is of utmost importance to confirm that the drug product remains stable when stored in drug containers. The heightened regulatory scrutiny is also reflected in the guidelines that have been produced by various regulatory bodies and organizations, such as the FDA, PQRI and Pharmacopoeia. Appropriate selection of primary packaging is critical and the pharma industry is increasingly choosing a polymer prefilled syringe.
This webinar will afford the audience a complete overview of the benefits of selecting a polymer system, with a focus on the features of TERUMO’s PLAJEX™ ready-to-fill polymer syringe system, which minimizes interactions with therapeutic proteins. More specifically the results of a formal extractable study on the components of this PFS system and the overview of the analytical study matrix and study set-up will be presented and discussed.
Stay up to date with the changing landscape of parenteral drug development and injectables and sign up today for the most up to date knowledge with this free webinar!
Director Technology Development - Terumo
Mr. William Dierick is the Director of Technology Development - TERUMO Pharmaceutical Solutions, a global research & development company, offering a wide range of innovative products related to drug delivery devices and injection technology, cardiology and cardiovascular systems, transfusion, patient monitoring and clinical systems.
With extensive experience in the Medical and Pharma sector for 40 years, Mr. Dierick has held various positions in Terumo, covering quality assurance, manufacturing, product development & engineering, project management, marketing, corporate planning and business development.
Mr. Dierick serves as expert of ISO/TC76 and ISO/TC84 and is an active member of MedTech Europe and volunteer of PDA.
Scientific Director - Toxikon Europe
From 2001 onwards, Dr. Christiaens holds the position of Scientific Director at Toxikon Europe where he develops analytical methods and protocols for both extractables and leachables studies for the Medical and Pharmaceutical Industries. Dr. Christiaens oversees all laboratory operations at Toxikon Europe and is also giving support to the European business development.
Piet Christiaens received his Ph.D. from the Analytical Chemistry Department of the University of Leuven (Belgium) in 1991. From 1992 to 1997, he was Lab Manager in two Analytical Contract Laboratories.
From 1997 to 2000, he worked as an independent consultant with Shell Chemical Company in Houston, TX (US) where he conducted research on a new hydrogenation catalyst system for Hydrogenated Triblock Co-polymers (Kraton Polymers).
Key Learning Objectives
- The changing injectable landscape with the emergence of biotherapeutics
- Overview of guidance and regulatory requirements on E&L
- PLAJEX™ ready-to-fill polymersyringes explained
- Presentation of a formal and elaborated extractable study on the components of PLAJEX™ with an overview of the analytical study matrix
- Pharmaceutical Development Project Management
- CMC Product Management
- Head of Device Development
- Device Platform Management
- Head of Drug Product Development
- Head of Formulation Development