APR January/February 2022 - 39

« INTERVIEW
fluid management; CDMO services, and formulation innovations.
Our approach is to work with customers to identify innovative
processing solutions that we can bring to market.
The role we played in supplying manufacturers with technologies
and services to combat the COVID-19 pandemic highlights
this approach. We pivoted quickly to supply urgently needed
manufacturing equipment, single use, and formulation products
and services to help vaccine manufacturers produce in a timely
fashion and with consistently high quality.
What is your approach in developing
new strategies to analyze protein
biopharmaceuticals?
We keep our eyes and ears open, attend conferences, and
constantly track new developments in the industry. Automation,
speed, accuracy, precision, and lowering the risk of errors are key
considerations in our approach.
Some of our current advancements are in the area of multi-attribute
methods, or MAM, which are based on peptide mapping and highresolution
mass spectrometry (MS) data. MS-only methods carry
the potential to replace older methods in QC release testing. At the
moment, we are evaluating how this may impact the future use
of chromatography in product release testing. What is essential
when using MAM for peptides is that the method provides
high resolution separations across a run. To ensure this we have
developed columns with pore sizes of 160 Å. For separating intact
proteins, or IgGs, we suggest using the particles of 400 and 1000
Å pore size.
Advancements are also expected that further automate sample
preparation for protein digestion and peptide mapping. In turn,
automation is an important consideration when developing
reliable, multi-site MAM methods. So, we are looking at new ways
for us to use our protein A and enzyme products in ways that are
amenable to automation.
What advice can you give to companies
developing mAbs? Which tools,
technologies and expertise should they
have in place to make the process as
efficient as possible?
Companies that develop and produce mAb therapeutics and other
biologics are constantly looking for innovative ways to improve.
Speed to market, quality, and robust supply are essential in the
industry. Our advice is to look at the entire development and
manufacturing process and find where technology can increase
quality and yield. Bottlenecks can be alleviated by careful process
development and introducing technologies that are fit for purpose
and have been proven to reduce cost, and increase yield and speedto-market.
Many emerging biotechnology companies do not have
the resources to study processes in detail but, with our knowledge
of the industry and relevant technologies, we can assist and be an
extension of any process development and manufacturing team.
We also produce thought leadership and applications content
to support clients who want to improve speed-to-market and
efficiency. This
includes
laboratory-based
process
modeling
at lab, pilot, and manufacturing scale, and customer-specific
troubleshooting. To assist in these studies, we have a global
network of M-Lab™ Collaboration Centers where customers can
simulate their processes with our equipment and technologies.
You're referring to the M-Lab™ network -
can you tell us more about this?
Our M Lab™ Collaboration Centers, the largest global network of
scientific experts, innovative technologies, and non-GMP facilities,
empower drug developers of all sizes to achieve manufacturing
excellence and innovation through collaborative exploration and
learning. Customers can expect to come in person or virtually to any
of our M Lab™ Collaboration Centers around the world and work
with our process engineers to demonstrate processing capabilities
and/or troubleshooting. All interactions are confidential and
specifically designed for the customer experience. In a nutshell,
the M Lab™ Collaboration Centers are there to demonstrate how
MilliporeSigma technologies can serve our customers.
Looking ahead, how will protein therapies
evolve and how will you meet the needs of
pharmaceutical companies as this market
segment grows?
Continued growth of biological medicines like vaccines, monoclonal
antibodies, and other recombinant proteins have accelerated our
efforts to offer innovative analytical and manufacturing solutions.
We have expanded our supply chains and capacities to meet the
growing demand and are looking to increase service offerings to
help companies achieve market supply consistency. Investments
will continue to be a driver and fuel our innovation pipeline.
This will strengthen our position as a key collaborator for next
generation processing, digitalization, and supply robustness.
www.americanpharmaceuticalreview.com |
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APR January/February 2022

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