Process characterization is an important step in the overall journey of product development. For therapies that have had early success in the clinic and are progressing toward commercial manufacturing, understanding the operational, regulatory and quality connections is critical for successful filing and launch. This case study proposes an approach for process characterization for the production of a monoclonal antibody, specifically at the drug substance biomanufacturing step.
The generation of foam is common in aerobic bioreactor systems. This application note outlines the cause of foam, use of antifoaming agents to control foam, design and integration of the single-use foam probe (including a mounting system and bioreactor controller integration), and several successful case studies utilizing the foam probe in aggressive bioreactor cultures. This study demonstrates that foam can be controlled across all S.U.B. sizes, 50 to 2,000 L.
Adoption of single-use bioreactor platforms across all scales, ranging from benchtop to production, are becoming increasingly popular due to their ease of use and operational flexibility. Knowledge of the performance characteristics at small-scale allows predictable and easy scale-up across the platforms from 3 L to 2000 L bioreactors. Learn more about the Mobius® family of single-use bioreactors for mammalian cell culture and recombinant protein production ranging from bench scale (3 L) to small scale (50 L), pilot scale/early clinical (200 L) and late clinical/commercial scale (1000 L and 2000 L) (Figure 1).
The path from DNA to clinic to drug-in-vial is long and complex. Upstream development is rich with opportunities to guide a promising molecule toward success. The choices made during upstream development can strongly influence the success of a biologic candidate. Following are some considerations that can simplify the process, improve process economics and minimize risk and uncertainty while helping customers deliver their molecules to market as quickly as possible.
Perfusion involves the constant feeding of fresh media and removal of spent media and product while retaining high numbers of viable cells within the bioreactor vessel. With the increased pressure to drive down manufacturing costs and to improve facility flexibility, there is a need to implement new perfusion-based approaches.
As gene transfer vehicles, lentiviruses exhibit many desirable properties, such as high transduction efficiencies, ability to infect both dividing and nondividing cells, and stable integration into the host cell genome. These properties make them well-suited for in vivo and ex vivo gene and cell therapies. However, cost-effective manufacturing of lentiviral vectors (LV) at commercial scales has proven difficult and remains a pressing issue for the marketing of therapies that depend on their application.
HCDC, an alternative to the traditional method for seed train expansion, can jump-start a manufacturing campaign by several weeks, removing a large part of the seed train from the critical path to production.
This video is an overview of the most advanced media format available for cell culture - AGT. A granular dry media format produced through a technologically advanced process which allows manufacturing of complete formulations in a dry format. It can be used in both fed-batch and perfusion cell cultures. AGT dry media is ready-to-use at target pH and osmolality. It is available in complete serum-free, protein-free and chemically-defined media formulations
The Thermo Scientific™ HyPerforma™ Single-Use Bioreactor (S.U.B.) is one of the most widely used S.U.B.s designed for mammalian cell culture. The HyPerforma S.U.B. has been widely adopted in process development (PD) and clinical trials, as well as in bioproduction of cGMP cell culture. The new Thermo Scientific™HyPerforma™ DynaDrive™ S.U.B. is the latest advancement based on our proven innovation, which offers better performance and accommodates larger volumes.
This brochure highlights the different BioContinuum™ platforms for seed train, production and harvest, flow through polishing, ultrafiltration, and buffer management.
This brochure identifies the technologies available based on the biomanufacturer need. See solutions for upstream productivity enhancements, high concentration formulations, harvest and buffer management solutions, and technologies to enable robust impurity and virus clearance.
Pellicon® single-pass tangential flow filtration (single-pass TFF) is a versatile technology for more productive, high capacity and cost effective downstream processes that allows facilities to meet the demands of higher titer and connected or continuous processes.
Multi-compendial to meet standards for packaged sterile purified water and sterile water for injection for further manufacturing. Compliant with United States Pharmacopeia (USP) and European Pharmacopoeia (EP) specifications.