QC in ATMP production: Sailing a stormy sea, what’s the key?
White Paper
Medicines based on genes, cells, or tissue engineering, i.e. Advanced Therapy Medicinal Products (ATMPs) are a rising star shining brighter and brighter in the horizon for any CDMO operating in life-science. It is natural that many reconsider strategies and set a new course toward this brand-new reality. However, it is neither an easy destination to get to, nor is the route smooth sailing. Rough seas are expected as each manufacturer bear the responsibility to put in place appropriate measures ensuring the quality of these unique products is maintained and simultaneously comply with the GMP prerequisites, and all under extremely strict timelines.
NorthX Biologics is a CDMO and Innovation Hub in Advanced Biologics, with +30 years of GMP production experience. The team provides process development and GMP manufacturing services with expertise in plasmid DNA, mRNA, proteins, cells and other advanced biologics. Headquartered in the heart of Sweden, the team serves customers worldwide and in 2021 was recognized as a national innovation hub for advanced therapeutics and vaccines. NorthX Biologics has the ambition to become a leading cell and gene therapy manufacturer and partner of choice for innovative drug development companies.
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