As a start up with multiple clinical programs within an accelerated track MeiraGTx started designing our processes and aimed to build facilities to ensure therapeutic drug products reach patients as quickly as possible. As scientists and as people this tends to be the main goal, and although there are many challenges to commercializing a therapeutic drug product this is only the first step. To be able to continually serve patients, the company must be set up in a way to be sustainable throughout the clinical phase until revenue can be generated via commercial sales. Understanding the patient and company needs are a key cornerstone for having successful products and a successful company transition from clinical to commercial products. Within this presentation Bastian Leewis will illustrate and explain the approach chosen by MeiraGTx for some of the platform components.
In the second half of the webinar, Ankita Desai, Bioprocess Field Specialist at Eppendorf will talk about bioprocess solutions for upstream bioprocess development and scale-up.
Upstream bioprocess development is an integral part of gene therapy product development. Cell culture bioprocess development is usually carried out at small working volumes. This helps save time and resources, because several experiments can be conducted in parallel, costs for media are kept low, and relatively little laboratory space is required. When more material is needed for characterization, trial runs, and finally for commercialization, biopharmaceutical companies transition the process to bench scale and then up to pilot or production scale. In this presentation, we will present bioprocess solutions for parallel process development at small scale. Furthermore, we will discuss bioreactor scalability and address several scaling approaches.
Date & Time:
September 25, 2019 at 10 a.m. EDT / 3 p.m. GMT / 4 p.m. CEST
Bastiaan Leewis, MSAT Manager of Industrialization at MeiraGTx
Ankita Desai, Bioprocess Field Application Specialist at Eppendorf North America