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.
Supporting Technical Content
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
Dry Powder Media Preparation and Handling
Article: Innovative Strategies for Cell Culture Media Preparation
White Paper: Mitigating Risks Associated with Cell Culture Media Preparation and Handling
White Paper: Compacted Cell Culture Media – Improving Solubility and Stability
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
Safe Handling and Efficient Mixing of Dry Powder Cell Culture Media
Dry powder cell culture media formulations provide many advantages for shipping and storage. To leverage these benefits, dry powder media formulations need to be highly soluble and homogeneous. These properties can be achieved by the combination of optimized milling procedures and suitable formulation technologies.
Additionally, media should arrive in a format that is convenient to handle, such as pre-weighed dry powder bags that connect directly to hydration tanks. This minimizes product contamination risks, safeguarding employees and facilities. When mixing, especially at high volume, good dispersion and dissolution of particles can be managed with specially designed single-use mixing systems.
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
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.