Cell and gene therapy (CGT) companies shifting from pure R&D and early preclinical work towards clinical-phase development encounter many major difficulties. The decision to outsource GMP manufacturing or to invest time, capital, and employees in developing in-house manufacturing abilities is critical.
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It is critical to identify the uniqueness of each CGT program and to scrutinize the intrinsic product needs—not just during early discovery, but also, hopefully, during clinical testing and commercialization. A company that has high expectations for its product candidates and platforms should create a tailored process development plan for each product.
This strategy should incorporate scale-up, but it must be balanced against competing goals such as timeframe to clinical trial, phase of development, amount of product needed per dose, need for single or repeat dosing, and justification of urgency (unaddressed medical needs where no appropriate alternative treatments are available).
Before committing to a partner, whether it is a therapeutics firm, a CDMO, or a supplier, sponsors must conduct thorough research because of the inherent complexity of cell and gene therapy products and manufacturing processes. Shared business culture, vision, and mission are undoubtedly crucial criteria for assessing partners.
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It is beneficial to use robust and comprehensive platform technology approaches that enable a smooth transition from small-scale bench research through pilot GMP applications to large-scale commercial manufacture. It would be ideal if the technology could link with eQMS, EBR, and ERP systems. Additionally, for a relationship to last, both partners must share a vision and have sufficient depth, resources, and track record of success to sustain the synergy and compatibility.
About Corning Life Sciences
A division of Corning Incorporated, Corning Life Sciences is a leading global manufacturer of cell culture products and solutions that enable academic, biotech and biopharma scientists to harness the power of cells to create life-changing innovations. Corning supports a range of application areas including core cell culture, 3D cell culture, bioprocess, cancer research, primary and stem cell research, drug screening, cell and gene therapy, disease modeling, lab automation and more.
Whether your goal is stem cell expansion or viral vector production, Corning Life Sciences platforms, including HYPERStack® vessels that maximize cell growth area in a small footprint, the high-yield Ascent® Fixed Bed Reactor platform, microcarriers, and closed system solutions can help get you there. Choose from hundreds of vessels, the widest selection of cell culture surfaces, and custom media in a variety of single-use technology configurations. Learn more at www.corning.com/lifesciences.