Pharmaceutical Technology LABORATORY BEST PRACTICES 2018 41
cluding near-infrared and Fourier-transform in-
frared spectroscopy are commonly used to assure
the identity and quality of raw materials. These
techniques allow a high volume of samples to be
tested in an economical and reliable way.
Bulpin (MilliporeSigma): Advancements and cost ef-
ficiencies in employing analytical methods/tech-
nologies now permit the use of orthogonal meth-
ods to assess factors that can be quantified and
compared during the testing of raw materials. In
addition, evolution of methods that allow for high-
throughput assessment and automation of many
tasks allow for raw material testing to be scalable
at production levels.
Foehr (Pacific BioLabs): Many raw materials used
in manufacturing may be analyzed using routine
methods and commonly available instrumenta-
tion. However, in this age of personalized medi-
cine, stem-cell therapeutics, and immune-oncol-
ogy drugs, the manufacturing of raw materials
may include growth factors or cytokines. These
raw materials require more advanced analysis and
instrumentation to ensure proper safety and qual-
ity. Manufactures may also use advanced instru-
mentation to track cell growth and the status of
growth conditions using multiplexed analysis of
dozens or hundreds of markers.
New gene therapy technologies may require so-
phisticated molecular biology techniques to char-
acterize the product and raw materials. Nucleic
acid-based therapeutics such as oligonucleotides,
RNAi, and CRISPR-based therapies are advanc-
ing through the approval process and required
biomanufacturing support. Techniques to study
viral vectors, such as adeno-associated virus, and
the raw materials used in their production are
becoming more important as new-gene therapy
drugs enter the market and are highly scrutinized
by regulators. PT
"Testing raw materials is
a routine requirement;
therefore, fingerprint
technology including near-
infrared and Fourier-transform
infrared spectroscopy are
commonly used."
—Browne, Almac Sciences
MORE ARTICLES
For more about raw materials, read the following articles at PharmTech.com.
• Ensuring the Biological Integrity of Raw Materials
www.pharmtech.com/ensuring-biological-
integrity-raw-materials-1
• Collaborating for Efficiency and Safety in Raw Material Inspection
www.pharmtech.com/collaborating-efficiency-
and-safety-raw-material-inspection
• Analysis of Raw Materials
www.pharmtech.com/analysis-raw-materials
• Ensuring Quality in Pharmaceutical Raw Materials
www.pharmtech.com/ensuring-quality-
pharmaceutical-raw-materials
• Managing Risk in Raw Material Sourcing
www.pharmtech.com/managing-risk-raw-material-sourcing-0
• Streamlining Raw Materials Testing
www.pharmtech.com/streamlining-raw-materials-testing-0
• Risk Reduction Top Driver for Biopharmaceutical Raw Material
Development
www.pharmtech.com/risk-reduction-top-driver-
biopharmaceutical-raw-material-development
• Supply Chain Security Tops Concerns for Biopharma Raw Materials
www.pharmtech.com/supply-chain-security-
tops-concerns-biopharma-raw-materials