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European Biopharmaceutical Review

The Quality Paradox of Development in a CDMO




Contract development and manufacturing organisations (CDMOs) offer a combination of both product development and GMP manufacture. Often CDMOs evolve from modest origins, and as they grow and broaden their range of services for process and analytical development to support clinical phase and commercial manufacture, they encounter challenges separating the quality requirements for each side. Their quality systems need to be flexible but rigorous to apply an efficient and appropriate level of control. One area where this quality challenge is observed is within the R&D groups where there is a need to develop methods or processes that will be suitable and robust for a future GMP environment, while at the same time maintaining the work rate throughput to evaluate all potential options and deliver on time. Thus, there is a paradox in the rapid development of a high-quality product.

Instructing teams to work on different equipment platforms and at differing quality levels risks error and inefficiency, so how does a CDMO manage this conundrum? It is valuable to identify some of the options available within the instrument marketplace and some optimised strategies that biopharmaceutical CDMOs may use to deliver, despite this paradox.

The Paradox

The development of biotherapeutics requires establishing a robust manufacturing process and a set of analytical methods to ensure that critical process parameters do not impact the critical quality attributes of the product. Furthermore, the final product must be tested to ensure its safety and efficacy by confirming that the product identity, purity, content, and activity remain within specifications. The development of processes relies on analytical data to demonstrate performance and allow next-step decision making. However, those same methods need to be developed using material from the same process. There is, therefore, an iterative progression of process and analytical development to have material to develop the methods that can then inform about the process.

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Alastair Waugh is Senior Head of Analytical Development at 3P Biopharmaceuticals, the Spain-based CDMO. He has over 15 years of biopharma industry experience and a previous academic career covering microbial genetic engineering, protein chemistry, and cancer biology. Alastair has been integral to many varied projects to support 3P's analytical control strategy as they progress along the product lifecycle. He has extensive experience in both mammalian and microbial products, manufacturing process, and development of bioanalytical methods.
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Alastair Waugh
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