16 BioPharm International eBook April 2019 www.biopharminternational.com
Outsourcing Resources Manufacturing
Complex and Customized:
Manufacturing New Molecular Formats
Increasingly complex monoclonal antibody molecules will require the
right "tool box" for scaling up manufacturing.
O
ver the past 35 years, the pharmaceutical
and biotech industry has made signifi-
cant strides in developing and scaling
up novel protein therapies (i.e., large-
molecule drugs). What was once a niche,
avant-garde pharmaceutical area is now an industry
mainstay. Today, monoclonal antibodies (mAbs) and
antibody-related products are being used in a range
of therapies—from treatments for asthma and rheu-
matoid arthritis that have patient populations in the
millions to more narrow diseases that affect no more
than a few thousand patients, such as paroxysmal
nocturnal hemoglobinuria. After decades of increas-
ing investment, advances in scientific understanding,
and technological improvements, the industry now
has standardized platforms to deliver high-quality
and large-batch biologics medicines to populations
worldwide.
Now that high yields have been achieved for the
first generation of mAbs, the next challenge will be
developing ways to produce larger quantities of even
more complex antibody formats. The pharma and
biotech industries are now discovering and design-
ing more advanced, complex, and diverse proteins
with high potential to advance novel treatments and
ustas/Stock.Adobe.com
ANDY RACHER is director, Future Technologies at Lonza Pharma & Biotech.
Twenty-three of his 31 years working in the field of mammalian-cell protein
production have been at Lonza Biologics, where he has held both managerial
and technical roles.
ANDY RACHER
