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    Mapping the road to seamless scale-up: Advancing clinical trials manufacturing from pilot to production

     Mapping the road to seamless scale-up: Advancing clinical trials manufacturing from pilot to production | Avantor The historic pace of new therapy development has challenged biopharmaceutical manufacturers to find new ways to make processes more efficient and ensure safe treatments get to patients faster. Key considerations include the transition from small-scale to large-scale production, necessitating rigorous adherence to current Good Manufacturing Practices (cGMP) and flexible manufacturing processes. This flexibility allows manufacturers to adapt to varying patient participation levels and material volume needs. This article also highlights the necessity of thorough planning for raw material supply and cGMP documentation to avoid inefficiencies and delays.

    Technological advancements, such as automated platforms and single-use technologies, are presented as crucial tools for mitigating risks and enhancing scalability. Collaboration with experienced solutions partners is recommended to navigate regulatory requirements and ensure successful scale-up from pilot to production phases.

    This comprehensive approach aims to streamline the scale-up process, ensuring that innovative therapies reach the market efficiently and safely, ultimately benefiting patients and advancing medical science.

    This article is published in European Pharmaceutical Manufacturing, Mar/April 2024, Vol. 24, Issue 2. 

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    Authors

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    Dr. Nandu Deorkar

    Senior Vice President, Research & Development – Biopharma Production, Avantor

    Nandu Deorkar is Senior Vice President, Biopharma Production Research & Development for Avantor. He is responsible for innovation strategy and planning, and execution of new products and technology development. During his more than 25-year career in research & development, Dr. Deorkar has been leading teams working on various aspects of upstream and downstream bioprocessing, single use systems, chemical/polymer R&D, drug development, formulation, drug delivery technologies, process development, and technology transfer. He has published more than 30 articles and holds more than 20 patents. Dr. Deorkar received Ph.D. from Indian Institute of Technology, Mumbai, India and MBA in Marketing from Fairleigh Dickinson University, Madison, NJ, USA.

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    George Marquez

    Vice President, Operation, Avantor

    George Marquez is “VP Clinical Services” in Avantor’s Services business unit. He leads business development, customer management, supply chain, and operations for the Clinical Services business. George has over 15 years of experience in the Medical Device and Pharma industries developing and executing operational and business development strategies. Additionally, George earned both his BBA in Operations Supply Chain Planning and MBA from the University of Texas El Paso.