July 9, 2020 Eliminating residual impurities in biopharmaceutical production starts with a strategic plan
Implementation a risk-based approach to identify and evaluate potential process related impurities in manufacturing process of biopharmaceuticals has manifold advantages.
A risk-based approach not only ensures product quality and patient safety, but also enables optimal process development with a suitable control strategy. Furthermore, it is possible to establish test methods in a timely manner to demonstrate the depletion of potential process related impurities during the manufacturing process.
Aline Denzel, Quality Control Manager and Stefan Braun, Regulatory Affairs Manager at Rentschler Biopharma joined industry experts in speaking to BioPharm International about why identifying the source, assessing the risk, and removing residual impurities requires a strategic Approach.
Overall, potential process-related impurities need to be evaluated regarding their criticality and their potential to pose any risk to patient safety, asserts Stefan Braun, regulatory affairs manager with Rentschler Biopharma. “The risk assessment should aim at identifying and assessing those molecules where an element of risk may remain even at very low concentration, with potential risk evaluated in a multi-stage approach,” he notes.
Finding suitable evaluation criteria that take into account the large number of different types of process-related impurities and defining a mathematically and scientifically sound way for determining toxicologically relevant limits for critical impurities can also be a challenge, according to Aline Denzel, quality control manager at Rentschler Biopharma. Furthermore, from CDMO’s perspective, she notes that the developed concepts should be applicable to many different customer Projects.
Therefore, Denzel says all raw materials used at a manufacturing site should be evaluated initially to define potential critical process-related impurities. A toxicological assessment with a relevant permitted daily exposure (PDE) value should be compiled by a registered toxicologist if required. She also notes that most PDE values are calculated based on the body weight of an adult, so application of the concept for pediatric products must be considered separately, as must different routes of administration.
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