Creating highly productive clonal cell lines is time-consuming, labor-intensive, and costly. Key considerations when choosing a cell line as the expression platform include:
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Biopharma manufacturers place strong emphasis on accelerated clone development, with good quality and regulatory-compliant material for pre-clinical trials. One approach for achieving these goals is the use of a Chinese Hamster Ovary (CHO) platform that includes cell lines and optimized media and feed; this allows fast, easy selection and scale-up of clones for manufacturing, typically reducing cell line development time by up to eight weeks.
A second approach is partnering with a contract development and manufacturing organization (CDMO) that possesses the expertise and technologies to fast-track process development. The CDMO can offer a customized approach, such as automated mini-pool selection, expression cassette design, and super-transfection.
Cell line characterization is required by regulatory agencies to confirm the species origin and history of the cell line, while testing identity, stability, and purity. Characterization includes phenotypic or genotypic identity testing and a broad range of tests for adventitious agents.
Production of a high-quality master cell bank (MCB) from the original therapeutic-producing cell line requires that cells be passaged regularly while in culture. However, this increases the chance of genetic alteration, contamination, and loss of expression constructs. It is therefore critical to passage the cells as few times as possible. To prevent alteration, cells are expanded and cryopreserved in a stable condition and stored at ultra-low temperatures. At later stages of development and manufacturing, a working cell bank (WCB) is required. A WCB is produced from a single vial of the MCB that has been grown for several passages and cryopreserved.
The complexities of biological manufacturing, along with product heterogeneity introduced by cellular expression systems, present significant challenges when measuring the quality of a biologic drug. Newer high-resolution analytical techniques for product characterization can address these challenges early on, providing answers to crucial questions such as the structural attributes of a drug, how it functions biologically, and the effects on clinical performance.
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.