Bioreactor Production

Upstream production

Stainless steel installations are often cost-prohibitive and time-consuming. In contrast, adoption of single-use or hybrid systems represents a faster, more flexible, and less capital-intensive route. When selecting a single-use bioreactor platform, key considerations include scalability and quality control:

  • To successfully implement a large-scale single-use bioreactor platform, equivalent performance or scalability with smaller sized bioreactors across the platform must be demonstrated. Characterization of key engineering parameters, including power input per volume, mixing time, oxygen transfer capabilities, and temperature mapping across all scales are required.
  • For single-use products and systems to meet high quality standards, there must be a mature quality control system in place. The system needs to manage the entire life-cycle, from component selection, testing and qualification, to assembly manufacturing, in-process testing, and final product release.

Supporting Technical Content

Managing Process Scale-up and Tech Transfer of an Upstream Suite

Converting from pilot to process scale and transferring technology requires precise and seamless organization, communication, and documentation. A well-developed technology transfer package:

  • Provides a clear understanding of the process and technologies
  • Determines the appropriate path to achieve goals of the project
  • Aligns with the pharmaceutical quality management system as outlined in ICH Q10


Upstream Strategy

Upstream Strategy

Successfully advancing molecules from the laboratory to the clinic quickly without sacrificing product quality, process efficiency, or patient safety

Cell Line Development

Development begins by selecting single-cell clones that can produce the biologic of interest, then screening for clones that are stable, productive, and scalable

Media and Process Development

Achieving consistent cell culture performance requires careful screening, selection, and optimization of media formulations and feed

Monoclonal Antibody Manufacturing

Monoclonal antibody manufacturing is a highly templated approach used to produce mAb-based immunotherapies. Robust, scalable process solutions are required at every step to ensure high therapeutic concentration and process safety, while meeting speed-to-market and cost containment concerns.

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