BioPharm October eBook: Best Practices 2018

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4 BioPharm International eBook October 2018 sinhyu/ Analytical Best Practices for Raw Materials Testing The testing of raw materials is essential as raw material quality determines the outcome of biologic product quality. B ecause the raw materials used in biologic drug development can impact drug interaction and patient safety, the testing of raw materi- als is necessary to ensure quality. BioPharm International spoke with several industry sources to discuss best practices for analytical testing techniques and instrumentation used for raw materials testing. The following is what Roisin Browne, site manager at Almac Sciences' analytical services site in Athlone, Ireland; Andrew Bulpin, head of Process Solutions at MilliporeSigma; and Erik Foehr, PhD, vice-president, Analytical Sciences, at Pacific BioLabs had to say. IMPORTANCE OF QUALITY BioPharm: What are some of the major impacts that raw material quality (or low-quality) can have on the production process and product quality? Browne (Almac): Control of raw materials is essential to maintaining safety and high quality. Thorough knowledge of raw material quality mitigates the poten- tial for contamination derived from sources such as microbes and chemicals. Bulpin (MilliporeSigma): Considering the goal of a biologic drug is to treat a patient, raw material qual- ity can ultimately impact the efficacy of the drug. FELIZA MIRASOL Biopharma Laboratory Best Practices Raw Materials Testing

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