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.
With a revolutionary three-dimensional macroporous hydrogel structure that provides a high density of binding sites and rapid mass transfer, NatriFlo® HD-Q chromatography membrane delivers binding capacity that exceeds resin-based columns with fast flow rates. This combination of performance and speed enables low-risk, scalable solutions for efficient purification of biologics.
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).
While the benefits of next generation bioprocessing are clear, there are multiple pathways to success and many options across a range of disciplines must be considered. See how the the BioContinuum™ Platform provides the building blocks to help you achieve your specific bioprocessing goals.
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.
The conjugation of polysaccharide antigens to the immunogenic carrier protein is a critical production step in the manufacture of CPS vaccines. This reaction rarely goes to completion, which therefore requires a separation of the free polysaccharides from the conjugated product. This separation is typically done by tangential flow filtration and it is challenging due to the small size difference between the product and the free polysaccharide contaminant. Customized TFF (Tangential Flow Filtration) membranes with tight pore size specifications have been shown to be effective in these applications, allowing maximization of product yield and purity.
Droplet Digital PCR (ddPCR) enables easy multiplexing of numerous targets within each fluorescent channel. Amplitude-based multiplexing achieves this by varying primer and/or probe concentrations. In probe-mixing multiplexing, probes are mixed at desired concentrations to place targets in a defined position on a 2-D plot. This paper describes strategies for both approaches using the large portfolio of ddPCR Assays readily available through Bio‑Rad.
Cellvento® 4CHO medium and its companion Cellvento® 4Feed were developed to grow a broad range of CHO cells. As the performance of production media and their companion feed(s) are typically interdependent, optimizing a feeding strategy is a crucial step to achieve high cellular growth while maintaining high specific productivity. The process guidance provides the basis for initiating feed optimization activities, but fine-tuning an effective feeding strategy should be considered.
Common fed-batch processes use highly concentrated alkaline feeds which create the need for complex control strategies to minimize pH spikes during feed additions. This brief provides a process guidance for the use of the modified amino acids Phospho-Tyrosine Disodium Salt and Sulfo-Cysteine Sodium Salt Sesquihydrate in fed-batch processes.
|
|
|
|
|
|
|
|
|