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WHITE PAPER

WHITE PAPER

Technology Transfer and Scale-Up of a High-Density E. coli Fermentation from a 200 L Stainless Steel to a 1,000 L Single-Use Fermenter

While single-use systems are common in mammalian cell culture, their adoption in microbial fermentation has been slower due to the high demands of oxygen transfer and cooling. ABEC’s Custom Single Run (CSR®) technology overcomes these challenges, offering single-use fermenters with the scalability and performance of stainless-steel systems.

BIOVECTRA leveraged ABEC’s CSR technology to scale a high-cell density E. coli process from a 200 L stainless-steel fermenter to a 1,000 L single-use fermenter. This collaboration demonstrated how single-use fermenters can deliver the performance of stainless-steel systems while offering the flexibility needed for diverse manufacturing needs and ensuring right-first-time scale up.

By overcoming key historical challenges in microbial fermentation, this approach highlights the potential for single-use technology to enable efficient scale-up and streamline multiple product production in a GMP environment.

Download this white paper to learn how scalable single-use systems can support reliable process performance and manufacturing flexibility.

About Us

With over 50 years of experience, we are a forward-thinking, North American CDMO specializing in clinical-to-commercial scale production of high-quality regulated APIs and Intermediates.

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Contact Us

Toll Free: +1 (866) 883-2872
Phone: +1 (902) 566-9116
Fax: +1 (902) 628-2045

11 Aviation Avenue,
Charlottetown, PE, C1E 0A1
Canada

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  • 20+ years at GSK, leading R&D activities on multiple vaccine programs
  • Recently held positions in industry include: Senior Director (Function Head), Protein Biochemistry; Director, Antigen Design & Prototype Production; and, Associate Director, Antigen Design and Protein Characterization.
  • Key areas of expertise are:
    • Process development of protein Biologics/Recombinant Antigens
    • Recombinant protein expression (mammalian, insect, yeast, bacterial)
    • Production/design of Viral Vectors, mRNA vaccines, Bacterial outer membrane vesicles
    • Protein Engineering and Structural Biology
    • Defining quality attributes, biophysical characterization of proteins, and analytical strategy
  • Post graduate degrees in Functional Genomics (Université Laval) and Bioinformatics (MIT); M. Sc. Microbiology and Immunology (Laval).
  • 25+ Patent & 5 Scientific Publications

Normand Blais – Senior Director Development & Innovation, Biologics

  • 20+ years at GSK, leading R&D activities on multiple vaccine programs
  • Recently held positions in industry include: Senior Director (Function Head), Protein Biochemistry; Director, Antigen Design & Prototype Production; and, Associate Director, Antigen Design and Protein Characterization.
  • Key areas of expertise are:
    • Process development of protein Biologics/Recombinant Antigens
    • Recombinant protein expression (mammalian, insect, yeast, bacterial)
    • Production/design of Viral Vectors, mRNA vaccines, Bacterial outer membrane vesicles
    • Protein Engineering and Structural Biology
    • Defining quality attributes, biophysical characterization of proteins, and analytical strategy
  • Post graduate degrees in Functional Genomics (Université Laval) and Bioinformatics (MIT); M. Sc. Microbiology and Immunology (Laval).
  • 25+ Patent & 5 Scientific Publications

Oliver Technow - Chief Executive Officer

  • Industry Master Degree from Frankfurt Chamber of Commerce, Frankfurt Germany.
  • More than 20 years of global pharmaceutical industry experience.
  • Held numerous leadership positions in commercial development, marketing and brand management, and lifecycle management and has extensive product launch and market access expertise in Europe and North America.
  • In 1997, joined Eisai GmbH in Frankfurt, Germany and in 2002, was appointed Director, CNS Business Unit; in 2006, was appointed Vice President, Head of Global Marketing for Eisai Inc. in Woodcliff Lake, NJ;  in 2011, was appointed Vice President, Established Products Business Unit; in 2013, was appointed President & General Manager for Eisai Limited in Mississauga, ON.
  • Appointed President of BIOVECTRA Inc., December 10, 2015.
  • Board Director for BIOTECanada
  • Member of the Steering Council of Innovative Medicines Canada (IMC)
  • In 2017, appointed to the Government of Canada’s Health/Bio-sciences Strategic Economic Table
  • In November 2019, promoted to Chief Executive Officer at BIOVECTRA
  • In June 2020, named new Chair of PEI BioAlliance Board of Directors