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Meeting review| How make limited time “quality time” to develop high-quality biologic drugs
Dec 11 , 2020
Website of the conference

December 9-10, 2020. The Bionnova Innovators China Forum 2020 was successfully held in Shanghai with the theme of innovation, cooperation, and reimagining as the theme to provide participants a deeper understanding of the commercialization of the biopharma industry.

Led significantly by policy reform for the overall pharmaceutical industry, publicly disclosed financial records indicate that biological drugs attracted a total of 7,551 million yuan (US$1.1 billion) of financing in 2019, of which antibody drugs accounted for more than 50%, reaching 4,957 million yuan (US$717 million). Biopharmaceutical companies are becoming increasingly competitive and the time from antibody discovery to IND application time has been greatly reduced compare with the past. Challenge, speed, quality, time, technology, cooperation: these words have become the key topics for competitors in the global biopharmaceutical development race. How to best use the limited time and resources to develop high-quality biological drugs is a common focus of attention.

Dr Nick Kotlarski, Chief Operating Officer of Bioworkshops, presented how an established CDMO can save both time and costs in the development of high-quality biologics. His presentation introduced a time and cost summary of the biopharmaceutical development lifecycle, from plant construction to labor operation and other significant contributors. Beyond the direct activities of biopharmaceutical development and production, an overarching quality management system is required to integrate knowledge of facility construction, quality control, regulatory compliance, and supply-chain management. As products move toward commercial production, mature quality systems, robust process platforms and rigorous GMP compliance may become key challenges, so more and more enterprises choose to work with CDMO to control costs, share risks, shorten drug development cycles, improve efficiency, and focus more resources on early research and development.


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Dr Kotlarski also accepted an exclusive interview with the conference organizers, to represent biopharmaceutical industry CDMO enterprises and answer questions on Bioworkshops will help biopharmaceutical development in the next five years and what innovations Bioworkshops bring to improve quality and reduce costs to deliver competitive advantage. Dr Kotlarski outlined that the accumulate years of industry experience in drug development within Bioworkshops team allow them to work with expert efficiency in line with the strictest international market standards in the European Union and the United States that bring both cost and time saving to local clients now that China's regulatory system has largely harmonized with these international requirements. Bioworkshops’ quality system and facilities meet the standards of China's NMPA, United States FDA, and the European Union member states, giving clients confidence that the services we provide meet requirements for the world's leading regulated markets. As Chinese companies increase innovation efforts to target the global markets with first-class products, we can provide fast, high-quality, and cost-competitive services.