Implementation Of An Affordable And Scalable Manufacturing Strategy For Gene Therapy Products
29th May 2019 | 10:00 am EDT / 16:00 pm CEST | Bastiaan Leewis, MSAT manager of Industrialization at MeiraGTx and Ankita Desai, Bioprocess Field Application Specialist at Eppendorf |BOOK FREE SEAT
As a start up with multiple clinical programs within an accelerated track we started designing our processes and aimed to build facilities to ensure therapeutic drug products reach patients as quickly as possible. This tends to be the main goal for scientists and patients. Because there are many challenges to commercializing a therapeutic drug product, ensuring smooth processes and suitable facilities are only the first steps. 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’s and company’s needs are a key cornerstone for having successful products and a successful company transition from clinical to commercial products. Within this presentation I will illustrate and explain the approach chosen by MeiraGTx for some of the platform components.
Presented by Bastiaan Leewis, MSAT Manager of Industrialization at MeiraGTx
Bastiaan Leewis is an experienced manager with over 10 years of cell and gene therapy experience and has worked in CMOs and an AAV product company. Within previous roles Bastiaan has been involved in and coordinated multiple technology transfers from Biotech and large Pharma to support clinical and commercial products. He has implemented project management systems to support technology transfers, bioreactor systems and automation to standardize workflows.
Within MeiraGTx, Bastiaan is responsible for implementing the process and analytical development to fit a broad pipeline of AAV products. Since starting in MeiraGTx, he has been involved with the GMP facility design which was built and certified in less than 18 months and is currently in the final stages of completing a new 300m2 development lab.
Sponsored by Eppendorf
Eppendorf is a leading life science company that develops and sells instruments, consumables, and services for liquid-, sample-, and cell handling in laboratories worldwide. Its product range includes pipettes and automated pipetting systems, dispensers, centrifuges, mixers, spectrometers, and DNA amplification equipment as well as ultra-low temperature freezers, fermentors, bioreactors, CO2 incubators, shakers, and cell manipulation systems. Consumables such as pipette tips, test tubes, microtiter plates, and single-use bioreactor vessels complement the range of highest-quality premium products.
Eppendorf products are most broadly used in academic and commercial research laboratories, e.g., in companies from the pharmaceutical and biotechnological as well as the chemical and food industries. They are also aimed at clinical and environmental analysis laboratories, forensics, and at industrial laboratories performing process analysis, production, and quality assurance.
Accuracy, reliability, experience, innovation — characteristics that customers all over the world associate with Eppendorf.
Eppendorf was founded in Hamburg, Germany in 1945 and has more than 3,100 employees worldwide. The company has subsidiaries in 26 countries and is represented in all other markets by distributors.
Followed by 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.
Presented by Ankita Desai, Bioprocess Field Application Specialist at Eppendorf
Ankita Desai is a Bioprocess Field Application Specialist at Eppendorf North America. She supports customers with her expertise in cell culture bioprocessing and applications. After her Master’s in Pharmaceutical Sciences at the Northeastern University in Boston, she has gained several experiences working for global players in the pharmaceutical industry.