From Early Stage to Late Stage Development: How to Characterize a Perfusion-based Vaccine Production Process Using QbD?
27th March 2019 | 10.00AM EST/16.00PM CET | Perrine Rouel, Scientist - Up Stream Processing, The Janssen Pharmaceutical Companies of Johnson & Johnson and Tom Jeffery, Application Specialist – Ambr Technology KAM Europe at Sartorius Stedim Biotech |BOOK FREE SEAT
The biopharmaceutical industry is known for its long time-to-market and for requiring large resources and time investment for product development. The type of activities required at the start of a biopharmaceutical product development focuses mainly on designing a suitable process for manufacturing as rapidly as possible material to be tested in pre-clinical and clinical trials. This is followed, upon success in early clinical trials, by a process optimization phase, which aims at increasing yields while reducing costs-of-good. Moving on towards late-stage development, the manufacturing process needs to be characterized, meaning that its robustness to produce the desired product quality when operated within certain process ranges needs to be demonstrated. This phase requires large numbers of development batches using elaborate analytical methods and advanced statistics, in order to fully study the relations between the manufacturing process and product quality.
Janssen Vaccines has transitioned over the last 3 years from early-stage process development to full late-stage development programs. In this presentation, we present the implications of such a transition, with the case-study of the QbD-based characterization of a perfusion-based PER.C6® cell culture process for Adenovirus vaccine production at Janssen Vaccines.
Presented by Perrine Rouel, Scientist – Up Stream Processing, The Janssen Pharmaceutical Companies of Johnson & Johnson
Perrine Rouel holds a Masters in biotechnology from ENSAIA (Ecole Nationale Superieure d’Agronomie et Industries Alimentaires option Biotechnologies, Nancy, France). After her graduation, she joined Crucell (in Leiden, the Netherlands) which is now Janssen Vaccines, the vaccine development company of Johnson and Johnson.
She worked on the implementation of Process Analytical Technology in the UpStream Process development department and on early-stage development projects. Since 2016, she has been working on the first late-stage development program within Janssen Vaccines and lead the Process Characterization for the UpStream Process department as a scientist.
Sartorius Stedim Biotech is a leading international supplier of products and services that enable the biopharmaceutical industry to develop and manufacture drugs safely and efficiently. As a total solutions provider, Sartorius Stedim Biotech offers a portfolio covering nearly all steps of biopharmaceutical manufacture. The company focuses on single-use technologies and value-added services to meet the rapidly changing technology requirements of the industry it serves. Headquartered in Aubagne, France, Sartorius Stedim Biotech is quoted on the Eurolist of Euronext Paris. With its own manufacturing and R&D sites in Europe, North America and Asia and an international network of sales companies, Sartorius Stedim Biotech has a global reach. In 2016, the company employed approx. 4,700 people, and earned sales revenue of 1,052 million euros.
and Tom Jeffery, Application Specialist – Ambr Technology KAM Europe at Sartorius Stedim Biotech
Tom has a strong background in biotechnology gained from working in various upstream development positions during the early part of his career. Upon first joining Sartorius in 2016, Tom worked within the Fermentation Marketing group in Sartorius’s Bioprocess division as an Application Specialist, where he provided technical pre- and post-sales support to customers, sales representatives and marketing for the development and implementation of Sartorius products and technologies.
Since the beginning of this year Tom’s focus is on the ambr portfolio, where one of his main remits is to ensure the training on ambr systems (both internally to colleagues and to Sartorius customers in EMEA) is of a high standard. More recently, he has been concentrating on the roll out of the ambr250 perfusion technology by delivering the first customer field trials in Europe’