There are many reasons for a pharmaceutical company to perform a tech transfer to a contract manufacturing organization (CMO). These include simplifying distribution logistics, safeguarding the supply chain, and improving the product or process being transferred, as well as expanding manufacturing capacity. However, sponsors must carefully evaluate CMO partners due to the high risk of problems – even failure – with technology transfers. To ensure that a tech transfer is smooth, swift, and successful, choosing the right CMO partner is essential.

This case study describes how AbbVie CMO performed an accelerated tech transfer for a humanized monoclonal antibody (mAb) that was approach-ing commercialization – reducing the time to PPQ by 25-50 percent. With demand for the product exceeding forecasts, the client had an urgent need to expand its manufacturing capacity. AbbVie CMO was selected as a secondary supplier owing to its proven track record in drug development and manufacturing at varying scales.

By drawing on its core strengths, including the flexibility to work with novel raw materials, AbbVie CMO was able to overcome multiple challenges and condense the tech transfer-to-PPQ timeline from a typical 12-18 months to just nine months – a term that could have been even further reduced had there not been proprietary material approvals to contend with. Importantly, the compressed schedule enabled the client to meet its commercialization goals and bring a life-changing drug to patients in the quantities needed.

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