Download: Whitepaper on single-use bioreactors for pilot-scale cell culture production
Rajesh Krishnan, Associate Director of Upstream Process Development at Gilead Sciences, kindly provided this whitepaper, entitled ‘A Comprehensive Strategy to Evaluate Single-use Bioreactors for Pilot-scale Cell Culture Production.’
Originally published in American Pharmaceutical Review, the whitepaper examines single-use technologies for biologics production. In particular, the paper provides a comprehensive evaluation of five commercially-available pilot-scale single-use bioreactors.
The paper suggests that single-use cell culture bioreactors can increase operational flexibility by:
- Reducing resources, cost, and time required for reactor turnaround, maintenance, and cleaning
- Reducing dependency on costly, hazardous, and potentially disruptive utilities (clean steam, WFI, CIP)
- Facilitating rapid response to shifting project timelines
- Offering potential cost of goods benefits
But, in spite of this, these bioreactors are still not widely accepted for large-scale biologics production, with primary concerns including large-scale facility fit, bag costs and supply, and the potential effect of the bags on process or product quality.
With this in mind, the whitepaper examines five single-use bioreactors, focusing on “their impact on process, product quality, and facility operations, as well as overall design advantages and concerns.”
For more information on this, get your copy of the whitepaper now!
Rajesh will be speaking at the upcoming Cell Culture World Congress USA event, taking place in Washington D.C. this November. He will participate in a panel session on the topic, ‘Quality by design: When, why and how?’ and will also present on the topic, ‘Improving shared technical change agendas across all stakeholders when outsourcing.’ Download the brochure for more information.