APR Nov/Dec 2022 - 32

»
SPECTROSCOPY
»
Raman Spectroscopy
Streamlines Process
Monitoring in
Biopharmaceutical
Manufacturing
Dean Stuart
Product Manager at Thermo Fisher Scientific
Raman spectroscopy is widely used in many applications - including
biopharmaceutical manufacturing - that require analysis of the
chemical composition of solid, liquid or gaseous materials. This
non-destructive analytical technique can not only provide detailed
information about the chemical structure, but also give insight into
the phase and polymorphy, as well as crystallinity and molecular
interactions. The drawback is that it often involves complex analytical
workflows and requires the use of highly specialized equipment
together with expert knowledge in Raman spectroscopy techniques.
New technologies have been introduced to the market in recent
years, making Raman technology more accessible to a wider
public through analyzers with intuitive control and user-friendly
interfaces. This article talks about the need for modern process
analytical technologies that are accurate and reliable - while being
more accessible to lab technicians - and how they can be used for
biopharmaceutical process monitoring.
Biopharmaceutical manufacturing has revolutionized modern
medicine through novel active ingredients that have enabled highly
specific and effective treatments for a range of diseases, including
cancer and autoimmune disorders. Biopharmaceuticals are created
by host cells that are made to express the desired product, which
is subsequently isolated, purified, and then formulated to ensure
a consistently safe and efficacious medicine. When working with
living organisms, the environment must be just right as even small
variations in parameters such as pH, temperature, dissolved oxygen,
feed composition and feed timing can affect the yield and quality.
It is therefore crucial to understand every aspect of each step in the
process to ensure optimal process control and avoid costly mistakes,
including failed batches, inefficient use of resources and end products
that do not pass quality control checks.
Careful Process Monitoring
Process production is a method used for bulk manufacturing of
goods such as pharmaceuticals, foods and beverages, refined oil,
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| November/December 2022
APR Nov/Dec 2022

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