The FDA recently published a guidance for the industry entitled 'Immunogenicity Assessment for Therapeutic Protein Products', with recommendations to minimize any aggregation risks.
Aggregation of therapeutic proteins is one of the most critical risk factors. It may have a negative impact on drug efficacy and safety due to the protein degradation inducing immune responses in patients.
Many of these aggregation risks are associated with the application of prefilled syringe systems including silicone oil, leached materials from the container closure system, such as, leached metals or organic compound and tungsten oxide. In addition to this, therapeutic proteins are likely to be sensitive to oxygen. A contribution to protein oxidation is related to the generation of radicals in the polymer prefilled syringe from sterilization by irradiation.
With this webinar Terumo will discuss on addressing these challenges with the Terumo developed PLAJEX™ polymer prefilled syringe platform. The PLAJEX™ Platform consists of a polymer based silicone oil-free prefillable syringe system in using a proprietary coated plunger stopper (i-coating™).
Join this webinar and discover how Terumo continues to improve drug delivery with innovative solutions and services!
William Dierick,
Senior Manager, Business Development
With extensive experience in the Medical and Pharma sector for more than 35 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, expert and convenor for ISO/TC84 and is an active member of Eucomed and volunteer of PDA.
Dr. Koji Nakamura,
Senior Manager, Business Development
With extensive experience in the Medical and Pharma sector for more than 14 years.
Dr. Nakamura has worked DDS formulation research, Drug and Device development and business development. Dr. Nakamura has received a doctor degree in pharmaceutical science.
Abe Yoshihiko,
Sr. Manager of Research & Development
- How to minimize the aggregation risk by choosing the right primary container
- Polymer based PFS
- Advantages of autoclave sterilization
- Advantages of a silicon oil-free syringe system
- Head of Primary Packaging
- Heads of Product Development
- Heads of Formulation
- Heads of R&D
- Heads of Procurement
- Heads of Technology
- Heads of Drug Delivery
- C-levels
- Project Managers
