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A prospective to develop affordable biologics for society

To maximize the productivity in the first capture step is a key to intensify the whole downstream process and would also be important to respond the upstream process intensification such as high cell density fed-batch and perfusion cultivation processes.

Cytiva’s Fibro technology is a complete disposable solution and expected to dramatically reduce process time, equipment scale and change over time, so those could contribute to the total cost reduction of biologics manufacturing.

We have evaluated the prototypes of Fibro Protein A both in lab scale (0.4 -4 mL device) and pilot scale (160 mL device) including the cycle lifetime study. We have understood both benefits and challenges of Fibro Protein A to implement it into the actual manufacturing facilities. In the webinar session I would like to share our evaluation data and discuss how and when we could effectively use Fibro Protein A through the biologic process development and manufacturing lifecycle.

Speaker:
Ashok Mishra, Head R&D Downstream department Lupin Pharma, India

Dr. Ashok Mishra is a process development expert for biosimilar products for global markets. He is currently heading the R&D Downstream department, Biotechnology division of Lupin pharma, and providing direction to cross-functional process and analytical teams. He has extensive experience designing drug substance manufacturing process, process characterization, virus clearance
validation, scale up, refolding, PEGylation, and technology transfer for process validation and commercial manufacturing.

Prior to Lupin, Dr. Ashok has worked at Intas Biopharmaceutical. There he was responsible for Downstream process development for the several biosimilar molecules based on bacterial and mammalian platform, development of PEGylated product and novel formulations. He was also responsible there for the plasma fractionation and development of the various plasma products.

Prior to Intas, Dr. Mishra has worked at Bharat Serums & Vaccines. There he was responsible to develop the purification process of several tumor markers, antigens from plural fluid, plasma, and card blood for diagnostics purpose.