Next generation processes: What model works the best in Asia?
09th August 2018 | 10:30AM IST | Ravishankar Kasturi, Vice President, Head of Manufacturing & Process Development, Reliance Life Sciences |ATTEND FREE WEBINAR
Compare and contrast the available full scale processing technologies, and discover what works the best for manufacturing next generation therapeutic products in Asia.
Biologics are complex and hard to make, which helps to explain why biotech manufacturing plants are huge and expensive to build. To be competitive, manufacturing must be efficient and cost-effective and should brainstorm economical ways to manufacture biologics.
Biosimilars are a cost competitive market. Pricing may have a direct impact on market share, and return on investment. The market for biologics, including approved and in pipeline like ADCs, antibodies & antibody fragments present both tremendous opportunity and challenge. Challenges necessitates looking beyond the current platform philosophy for how to modify the process with a goal to increase overall productivity in a flexible manner.
The current processing paradigm of large manufacturing facilities dedicated to single product production is no longer an effective approach for manufacturing next generation therapeutic products in Asia.
Cost Effective Biosimilars Manufacturing may include
- Single-use technologies and continuous upstream processes have proven to be cost-efficient options
- Aspects of continuous manufacturing in both upstream and downstream manufacturing are being incorporated thereby increasing yields through a combination of longer production run times, more stable and higher secreting cell lines
- Technologies enabling high productivity, right-sized, small footprint, continuous, and automated operations are being evaluated.
- Adaptive control techniques are set to minimize development timelines and enhance process robustness
Partnerships will continue to transform biosimilars industry. In order to gain access to developed markets, Indian biosimilar manufacturers are partnering with multiple local established manufacturers and big pharmaceutical companies.
Presented by Ravishankar Kasturi, Vice President, Head of Manufacturing & Process Development, Reliance Life Sciences
Ravishankar Kasturi is Vice President Manufacturing Operations and Process Development at Reliance Life Sciences in Navi Mumbai, India. He manage all aspects of process development and GMP manufacturing to produce biosimilars for clinical and commercial supplies. The portfolio of products include proteins derived from microbial fermentation and mammalian cell culture covering cytokines, monoclonal antibodies, hormones and glyco proteins. His prior assignments were at Dr Reddy’s Biologics,. Hyderabad, and Uni-Sankyo ltd,. Hyderabad. He received his M.Tech in Bio-Chemical Engineering from Andhra University , Vishakhapatnam and his Bachelors in Pharmacy from Gulbarga University , India.
Sponsored by Pall Biotech
Presented by Marc Bisschops, Director Continuous Bioprocessing – SLS
Prior to joining Pall, Marc was CSO at Tarpon Biosystems, the company that developed the BioSMB® technology. Marc held several scientific and management positions in the field of process development departments in Batavia Biosciences, Xendo. He has established a significant track record in completing projects related to continuous chromatography and continuous downstream processing. With over 250 projects completed, he is one of the leading scientists in this area.