Bioreactor 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.
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Our off-the-shelf and customizable bioprocessing cell culture media (CCM) products enhance productivity in upstream mAb, vaccine, gene/cell therapy processes.
The Mobius® Bioreactor family offers single-use bioreactors for cell culturing from early development to commercial production, supporting various scales.
Explore Mobius<sup>®</sup> single-use mixing solutions for pharmaceutical ingredient blending and process solution preparation.
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
Visit our document search for data sheets, certificates and technical documentation.
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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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