GeminiBio has an extensive history supporting the cell therapy research and development market, offering a portfolio of human serum products which are generally used in a growth medium for cell therapy biotechnologies such as chimeric antigen receptor T cell (CAR-T) therapies. As the cell therapy market has matured, including the successful US FDA approval of CAR-T therapies targeting blood cancers such as leukemia and lymphoma, the company has worked closely with customers to address evolving global regulatory requirements pertaining to ancillary products, such as human AB serum, used in the cell therapy manufacturing process.
To further support regulatory requirements in different regions around the world, GeminiBio is introducing a new human AB serum – GemCellTM Plus Xeno Free, World Grade. To meet specific regulatory requirements, including requirements within the United States and the European Union, the source plasma is collected from a maximum of 16 healthy male donors of the AB serotype. The donor material must also pass extensive viral testing requirements, and the manufacturing process includes defibrination of the source AB plasma using therapeutic grade recombinant human thrombin. GeminiBio manufactures all human serum products under cGMP.
“I am excited to offer our customers the new GemCellTM Plus Xeno Free, World Grade product”, said Rob Perry, GeminiBio’s Chief Scientific Officer, “as GeminiBio routinely supports our customers as they work to address questions from the various regulatory bodies. This new product represents an important addition to our product portfolio, as it allows customers to address the requirements for a limited number of donors in a pool without the cost or potential cell culture performance degradation associated with gamma irradiation, and with the benefit of large lot sizes.”
GemCellTM Plus Xeno Free, World Grade comes standard in 125mL bottles, and can be custom manufactured to meet customer’s unique fill size and containment requirements, including single use cryo-bags, which can streamline customer’s manufacturing workflows and improve aseptic processes.
About GeminiBio
Founded in 1985, GeminiBio serves the global biotechnology industry, from basic research to commercial production, with a focus on helping our customers accelerate the development of life enhancing biotherapeutics by streamlining and improving their cell culture and process liquid manufacturing workflows. The company’s products are organized into two core verticals – Cell Culture Solutions and Process Liquid Solutions. Located in West Sacramento, California, GeminiBio has 57,000 square feet of cGMP manufacturing space that is segregated between animal origin free and animal component manufacturing. GeminiBio is an ISO 13485:2016 certified, FDA registered Class 1 Medical Device Manufacturer, aligned with 21 CFR Part 820.
https://www.prnewswire.com/news-releases/geminibio-launches-human-serum-ab-product-for-global-cell-therapy-market-302069498.html
Check out our AAV CDMO service to expedite your gene therapy research
PackGene Biotech is a world-leading CRO and CDMO, excelling in AAV vectors, mRNA, plasmid DNA, and lentiviral vector solutions. Our comprehensive offerings span from vector design and construction to AAV, lentivirus, and mRNA services. With a sharp focus on early-stage drug discovery, preclinical development, and cell and gene therapy trials, we deliver cost-effective, dependable, and scalable production solutions. Leveraging our groundbreaking π-alpha 293 AAV high-yield platform, we amplify AAV production by up to 10-fold, yielding up to 1e+17vg per batch to meet diverse commercial and clinical project needs. Moreover, our tailored mRNA and LNP products and services cater to every stage of drug and vaccine development, from research to GMP production, providing a seamless, end-to-end solution.
Related News
Skyline Therapeutics Receives FDA Orphan Drug Designation for Gene Therapy for Retinitis Pigmentosa
BOSTON & SHANGHAI, September 2, 2024 – Skyline Therapeutics, a gene therapy company focused on innovative treatments for rare and severe diseases, announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for SKG1108....
Novavax Receives Emergency Use Authorization for Updated Covid-19 Vaccine
Novavax has received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its updated Covid-19 vaccine, NVX-CoV2705, joining other vaccine manufacturers in addressing evolving virus variants. The EUA permits the use of Novavax's...
Turn Biotechnologies Reports Historic Skin Cell Rejuvenation Breakthroughs at ESDR this Week
Company will present data from its successful rejuvenation of fibroblasts and keratinocytes to influential gathering of international dermatologists MOUNTAIN VIEW, Calif., Sept. 4, 2024 /PRNewswire/ -- Turn Biotechnologies, a developer of novel mRNA medicines and...
H5 influenza vaccines: What needs to be done to reduce the risk of a pandemic
As the global threat of H5N1 influenza looms with outbreaks across species and continents including the U.S., three international vaccine and public health experts say it is time to fully resource and support a robust strategy to address this and future potential...
Related Services