APR January/February 2022 - 38

» INTERVIEW
»
QC Executive Q&A
Research and
Development of
P r otein-Based
Therapeutics
Lee Madrid, PhD
Head of Global BioPharm Center of Excellence
MilliporeSigma, Burlington, MA
A business of Merck KGaA, Darmstadt, Germany
Geoffrey Rule, PhD
Principal Scientist
MilliporeSigma, Bellefonte, PA
A business of Merck KGaA, Darmstadt, Germany
In general, what tools and services
does MilliporeSigma provide to
biopharmaceutical companies that develop
or manufacture protein therapeutics?
As a global provider, MilliporeSigma offers a wide range of products
and services to biopharma. On the analytical side, we have a growing
selection of chromatography and sample preparation products for
development and QC laboratories. This includes enzymes for protein
digestion and glycan release, reagents for derivatization, consumables
(including SPE and MWCO filtration products), and high purity solvents.
In analytical chromatography we offer a range of wide-pore, superficially
porous particle (SPP) chemistries, both in UHPLC and HPLC particle
sizes, that we call BIOshell™. These particles improve separations of
peptides and large therapeutics like mAbs and other biomolecules. In
addition to SPP we offer monolithic silica column chemistries, including
a high-resolution version, as well as a new line of carbon-based HPLC
columns we call Supel™ Carbon.
On the services side, we provide flexible, custom solutions for
biologics manufacturing, including solutions for viral therapies,
and biosafety testing under the BioReliance® brand. We enter into
comprehensive partnerships with companies to support their entire
journey from development to commercialization, with product
characterization, lot release, and stability a focus. Our laboratories
are equipped with a wide range of analytical instruments, all
installed and maintained in compliance with cGMP requirements
and operated with validated methods.
How has the growth of protein-based
biopharmaceuticals impacted the
market and the technologies you offer
to the industry?
Protein-based therapeutics and prophylactics have consistently
seen double-digit growth over many years. The stream of new
biological medicines has transformed many debilitating diseases
into manageable and, in some instances, curative outcomes. This
has been highlighted by novel monoclonal antibody therapeutics
and recently, the surge of mRNA-based vaccines to combat the
COVID-19 pandemic. This growth in the market has fueled many
innovations in our industry. We have responded by launching
innovations in process and manufacturing science, including aseptic,
tangential, and nano (viral) filtration; purification technologies like
chromatography resins and membranes; cell culture production
and media technologies; single and multi-use systems for process
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| January/February 2022

APR January/February 2022

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