Next generation processes: What model works the best in Asia?

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

 
Continuous Bioprocessing- from Vision to Reality
With increasing economic pressure and stronger competition, especially in the evolving market of biosimilars, the reduction of manufacturing cost becomes a priority challenge for the biopharmaceutical industry. Strategies for process intensification include the implementation of both single-use technologies and continuous processing. Different to today’s classic batch processing, continuous manufacture uses integration of unit operations which leads to one interconnected product flow throughout several processing steps.
To enable continuous manufacturing of biopharmaceuticals, specific technologies are required. Pall Biotech has therefore developed a product portfolio that covers the complete manufacturing process from clarification to final filtration of the purified product. In-depth process development knowledge and evaluation of regulatory aspects of continuous processing complements the portfolio. Several fully integrated continuous DSP platforms have been developed in the past years, for example by Merck & Co.Inc., Sanofi-Genzyme, Bayer and Pall Biotech. These examples show how integrated processing holds the potential to improve productivity, lead to a higher degree of process control and reduce the size of unit operations which also translates to buffer, resin and consumable savings.
The presentation provides an overview of the trend towards continuous bioprocessing and shows benefits and current concerns of its implementation. Four case studies of hybrid and fully integrated continuous processes are shown as examples of how continuous processing can impact a manufacturing facility.
 
Presented by Britta Manser, Scientist Continuous Bioprocessing
Britta Manser moved to Pall International in 2016 after obtaining a Master’s degree in Pharmaceutical Biotechnology from Zurich University of Applied Sciences.  In her role as continuous bioprocessing scientist, she is focussing on the development, implementation and integration of continuous technologies, especially continuous chromatography applications. In the past years she has implement continuous bioprocessing solutions at various biopharmaceutical companies throughout Europe.
 
 
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