CBM, Nucleus Biologics, and Stoic Bio have launched a collaborative partnership to expedite the sustainable development of CGT therapies.
The Center for Breakthrough Medicine (CBM) is a contract development and manufacturing organization (CDMO) located within The Discovery Labs’ campus in King of Prussia, PA.1 On March 7th, the company announced a supply agreement that makes Nucleus Biologics their preferred supplier of cell culture media and other critical biological solutions.
CBM, Nucleus Biologics, and Stoic Bio are naturally aligned; CDMOs like CBM put a lot of effort into identifying a cell culture media supplier that can offer consistent product quality and sufficient manufacturing capacity to meet the stringent and demanding needs of their customers. CBM’s goal is to accelerate the development and manufacture of advanced therapies to alleviate the critical lack of capacity that is preventing patients from accessing critically needed cell and gene therapies. The company manages multiple clients taking their biological medicinal products from early-stage development all the way through to commercial manufacturing, so the ability to scale up quickly and efficiently is a must.
Nucleus Biologics has shown that the efficacy of cellular therapeutics is tightly tied to growth media formulation and has the expertise to understand how custom media can be used to optimize critical quality attributes. For example, PhysiologixTM, the company’s xeno-free media supplement, was recently featured in a publication2 on enhancing CAR T cell anti-tumor function, while NB-ROC™, their signature serum-free T cell media, has been shown to significantly boost T cell transduction efficiency while preserving the relevant phenotypes to support the development of CAR-T cell therapies.
Nucleus Biologics’ cell culture media formulation and manufacturing services are designed to seamlessly scale production from anywhere between 2L and 2000L lot sizes, so they can support CBM clients and activities from the R&D stage through manufacturing.
The new partnership also means CBM will be an early adopter of KrakatoaTM, Stoic Bio’s point-of-use media maker. The innovative media maker is a model of the sustainability the industry is striving to adopt – media production using Krakatoa results in 65% less CO2 emissions than conventional media production, and allows researchers to produce traditional or custom media fresh in their own lab or bioreactor suite.
The media maker uses pods constructed from 96%
biodegradable and recyclable components. Custom or traditional powdered media formulations are solubilized on-site in a sterile process, then dispensed into 500 mL autoclavable glass bottles. Most media pods can be shipped and stored at room temperature, significantly reducing the need for cold chain requirements, and avoiding the risk of sub-optimal cell performance or the cost of wasting expired cell culture media. Krakatoa will allow CBM to quickly iterate on formulation design to optimize therapies and do so in a sustainable manner.
Nucleus Biologics and Stoic Bio are thrilled to be a trusted partner for what will soon be the world’s largest single-point CGT manufacturing facility. CBM’s custom built labs are designed to handle process development, viral vector manufacturing, cell therapy manufacturing, and much more. Nucleus Biologics and Stoic are uniquely positioned to help support CBM’s goals in a manner unique to the industry. This partnership is truly poised to advance the development of next generation therapeutics.
Please visit our website to read the full press release and learn more about our latest collaborative partnership.
References
- The Discovery Labs. The Center for Breakthrough Medicines is Building the World’s Largest Cell and Gene Therapy Contract Development and Manufacturing Organization (CDMO) to Launch in King of Prussia, PA. Cision PR Newswire. Jan 2020.
https://www.prnewswire.com/news-releases/the-center-for-breakthrough-medicines-is-building-the-worlds-largest-cell-and-gene-therapy-contract-development-and-manufacturing-organization-cdmo-to-launch-in-king-of-prussia-pa-300991566.html - Ghassemi, S., et al. Enhancing Chimeric Antigen Receptor T Cell Anti-Tumor Function through Advanced Media Design. Molecular therapy. Methods & clinical development, 2020, 18, 595–606. https://doi.org/10.1016/j.omtm.2020.07.008
