4 BioPharm International eBook October 2018 www.biopharminternational.com
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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