38 Pharmaceutical Technology LABORATORY BEST PRACTICES 2018 P h a r mTe c h . c o m
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Raw Materials Testing
B
ecause the raw materials used in biologic drug development
can impact drug interaction and patient safety, the testing
of raw materials is necessary to ensure quality. Pharma-
ceutical Technology spoke with several industry sources
to discuss best practices for analytical testing techniques and in-
strumentation 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
PharmTech: 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 potential 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 quality can ultimately impact the
efficacy of the drug. Low-quality raw materials or impurities in the
raw materials can impact other qualities of a biologic, including shelf
life. Fortunately, integration of process control procedures during
the development of manufacturing processes, including managing
the supply chain for raw materials, can catch or prevent many issues
from harming the final drug product.
Where animal-derived products are used in the development or
manufacture of biologics, there is also an inherent risk of adventi-
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.
Feliza Mirasol
