APR May/June 2023 - 66

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BIOPHARMACEUTICALS
»
Next-Generation Cell
Line Development
for Biotherapeutics
Applications
Driving Precision and
Productivity from the
Molecular Level
Anis H. Khimani, PhD
Senior Strategy Leader, Life Sciences Strategy Group
Revvity
Tanaya Surve
Senior Scientist, Bioproduction Group
Revvity
Biotherapeutics - A Snapshot
Drug development has evolved significantly over the past couple
of decades, particularly within the large molecule biotherapeutics
arena. In a growing market, the therapeutic specificity of
biotherapeutics has resulted in a number of modality options. In
addition to offering precise targeting capabilities compared to
traditional small molecule drugs, large molecule medications can
potentially offer more profitable financial return. Drawing from the
success of biotherapeutics, biosimilars are being developed as costeffective
alternatives to the high price point of first-generation drugs.
For the discovery and development of large molecule drugs,
technologies have focused on advancing upstream and downstream
stages of the value chain. Focus on critical factors upstream in drug
design, enables companies to predict and prevent downstream
issues that might lead to delays in drug approval or costly recalls. The
importance of biotherapeutics continues to expand across various
types of modalities from monoclonal antibodies, and with increasing
interest in bispecific and multispecific antibodies, to nanobodies and
recombinant proteins. Each modality offers several prophylactic or
treatment options against disorders such as rheumatologic diseases,
cancer, diabetes, anemia, infectious diseases, and more.
Cell Line Development in
Biotherapeutics - A Convoluted Journey
The upstream workflows in biotherapeutics development have
witnessed significant progress in cell line development (CLD), clone
selection, scale-up, automation, and digitization to enable precision
as well as productivity. These transformative advancements across
the biotherapeutics value chain have also contributed to increased
agility and enablement of regulatory compliance. The recent
pandemic has accelerated the process to deliver drugs to market
while still maintaining high quality, safety, and efficacy standards.
From the COVID-19 experience, as scientists and innovators, we have
learned that vaccines, small and large molecules, as well as related
biotherapeutics development has called for more collaboration among
drug developers, technology providers, supply chain organizations,
and regulators at a global level.
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| May/June 2023
APR May/June 2023

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