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Pharmaceutical Manufacturing and Packing Sourcer

Choosing a CDMO Partner for Your Highly Potent Drug Development to Commercialisation Journey

The importance of selecting the right partner for managing the development to commercialisation lifecycle of products containing HPAPIs cannot be underestimated. The safe handling of products classified as highly potent is growing in complexity along with the associated regulatory requirements, therefore, identifying and assessing a partner with the specialist capabilities to take a product through to commercial launch is of critical importance.

Some companies may work with multiple vendors during the clinical development to commercial cycle, whereas others choose to identify and work with one partner able to manage different stages of the process. Whichever path is taken, conducting full due diligence as part of the vendor selection process to ensure that a partner is able to meet all required criteria will be key to a successful project.

How do you assess risk and evaluate highly potent containment strategies or a potential partner?

Confusion in classification is the first obstacle to overcome. Organisations may use different terms when classifying HPAPIs: occupational exposure bands, occupational health categorisations, control bands, and some larger companies may use their own in-house classifications. Irrespective of what is used by the client company, it is essential that a transfer of all data is conducted to allow the chosen vendor to make an accurate assessment using their established criteria. A risk assessment framework is required in order to determine the probability of exposure based on a combination of occupational hygiene and containment procedures in place remembering that a risk assessment is not a one-off exercise, but something that needs to be monitored and repeated as additional data become available.

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Dr Rebecca Coutts PhD graduated from the University of Bath with a Batchelor in Pharmacy before completing a PhD in Pharmaceutics from Cardiff University, Wales. Rebecca is also a registered member of the General Pharmaceutical Council. Over her 25-year career, Rebecca has shown a clear passion for development services and currently holds the role of General Manager for PCI Pharma Services at its Tredegar site, PCI’s centre of excellence for manufacturing services. Prior to this, Rebecca held roles including Director of Development for the site with specialist expertise in the development and processing of highly potent molecules, and Associate Director of Contained Manufacturing. Before joining PCI, Rebecca held multiple roles including; Head of Pharmaceutical Development for Vectura and Group Leader, Manufacturing, Science, and Technology Services at Abbott Laboratories.

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