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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

mAb Expression, Purification, and Formulation

mAbsizer™ Calculator

Single-use Upstream Suite Implementation and Quality Control

Webinars:
Implementation of Single-use Upstream Technologies in Fed-batch Operations
Review of a Supplier's Quality Control While Manufacturing Single-use Systems
Overcoming Quality and Regulatory Challenges of Implementing Single-use Pharmaceutical Manufacturing

Article: Managing Quality in Single-use Systems

Bioreactor Scalability

Webinar: A Scale-up to 2000L, Blindfolded!
Article: Demonstrating Process Scalability with Robust and Turnkey Platforms
Article: Mobius® Single-use Bioreactors: Platform Scalability

Tech Transfer

Webinars:
Tech Transfer and Scale-up – Tips and Tricks from a Biodevelopment Center
Managing Process Scale-up and Tech Transfer

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

Workflow

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.

Related Product Categories
Bioprocessing Cell Culture Media
Our off-the-shelf and customizable bioprocessing cell culture media (CCM) products enhance productivity in upstream mAb, vaccine, gene/cell therapy processes.
Bioprocessing Mobius® Single-Use Bioreactors
The Mobius® Bioreactor family includes the bench scale (2 mL and 3 L), pilot, clinical and commercial manufacturing (50 – 2,000 L) single-use bioreactors that enable cell culturing capabilities from early process development through commercial batch production.
Single-Use Mixers
Our complete range of Mobius® single-use mixing solutions can meet your needs for mixing pharmaceutical ingredients from intermediate to final drug products, as well as preparation of process solutions such as buffers and media.
Related Services
Emprove® Program
Confidently speed your way through the regulatory maze and fast track your new drug to market with the Emprove® Program. High-quality products, comprehensive documentation, and superior customer support facilitate your efforts in qualification, risk assessment, and process optimization.
Bulk Powder Transfer Bags
EZ BioPac® and Right Sized Weighing is a complete solution for easy and safe delivery of cell culture media and bioprocess chemicals. Our powder transfer system is designed to deliver exact weight of dry ingredients up to 100 kg and offers the right options for direct connection to your hydration vessels.

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