Outsourcing
Tech transfer: From bottleneck to boon
Outsourcing arrangements have been crucial to the roll-out of Covid-19 vaccines, and the pandemic has focused the industry’s gaze on the importance of broader collaboration, truly effective outsourcing relationships and the need to avoid bottlenecks in the technical transfer phase. Sponsors and CDMOs need to be comfortable sharing the same brain, which means building trust, engaging in full disclosure and creating a platform for collaboration. Jim Banks speaks to Michael Mulkerrin, vice-president and head of CMC at ADC Therapeutics, to find out the ingredients of a smooth technical transfer .
peed has been vital to saving lives during the Covid-19 pandemic, whether in the design of diagnostic tests, the development of vaccines or the delivery of life-saving equipment to hospitals. Speed, though, cannot come at the expense of rigorous research and quality control. Finding the right balance has been hard, but the development and distribution of Covid-19 vaccines have put a spotlight on the pain points that slow down the manufacturing process. Overcoming those problems has led to invaluable insights into pharmaceutical manufacturing and, in particular, how the transfer of technical capabilities to outsourcing partners can be handled better in the future. One of
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the most important realisations has been that, for some of the complex Covid-19 vaccines and biological therapeutics, fast manufacturing requires not only an increased physical production capacity, but also access to knowledge not contained in patents or in other public disclosures. Typically, the need to reverse-engineer originator companies’ manufacturing processes has been a major cause of both expense and delay in the creation of biosimilar products. However, the Covid-19 vaccine development process could herald a more collaborative approach across the industry and a new attitude to how critical technical knowledge is shared.
World Pharmaceutical Frontiers /
www.worldpharmaceuticals.net
Parilov/
www.shutterstock.com
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