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Advancements in cell culture and protein technology have opened the door for new therapies.
Advancements in cell culture and protein technology have opened the door for new therapies, according to Wendy Saffell-Clemmer, director research at Baxter BioPharma Solutions.
PharmTech: During your 23 years in the pharmaceutical industry, how has it evolved? What advances have been made?
Saffell-Clemmer: At the start of my career, recombinant protein technology was limited to a few expression systems, mainly Escherichia coli (E. coli). Advancements in mammalian cell culture enabled production of glycosylated proteins and led to the explosion of recombinant monoclonal antibody (mAb) therapeutics and optimized mAb-based therapeutics, such as bispecific antibodies and antibody-drug conjugates (ADCs). The growth in biologics, particularly in mAb-based therapeutics, has resulted in changes in drug development and manufacturing. Increased analytical characterization is needed throughout development, particularly in the areas of aggregation and subvisible particle detection. Additionally, demand for lyophilization development services, particularly for ADCs, has increased. Changes have been required in the manufacturing environment as well, as concerns about shear sensitivity have driven biologics customers to move from piston pumps to peristaltic pumps for some pre-filled syringe products.
PharmTech: What are the top three innovations that have changed the industry the most over the past 40 years and why?
Saffell-Clemmer: Recombinant protein technology, the sequencing of the human genome, and the ability to humanize mAbs have opened vast new targets and potential therapeutics for immunological diseases and the growing new field of immuno-oncology. These technologies have changed active pharmaceutical production from chemical process to biological process, driven demand for aseptic production, and required the introduction of new complex analytical technology into product development and quality control laboratories.
PharmTech: How have regulations advanced or hindered advances?
Saffell-Clemmer: Over the course of the past 20 years, the expectations have increased for the application of good documentation practices, data integrity, and other quality best practices such as quality-by-design. While development of quality-by-design approaches for process steps such as lyo-cycle development required significant research and proof-of-concept testing, the implementation has resulted in more data-driven and faster development timelines with improved process definition and lower risk.
PharmTech: What do you foresee for the next 10 years?
Saffell-Clemmer: In the next 10 years, rising incomes in countries such as India and China will fuel increasing demand for biologics and create new markets for biosimilars.
Wendy Saffell-Clemmer has been a member of Pharmaceutical Technology’s Editorial Advisory Board since 2012.
Vol. 41, No. 7
When referring to this article, please cite it as PharmTech, “Perspective: Biologics Advance the Pharma Industry,” Pharmaceutical Technology 41 (7) 2017.