Linking the gap from development to robust manufacturing
The complex journey of bringing a biologic to market – part 3 It is a critical shift for companies when transitioning from early development to clinical production, where you transfer ...
Progressing bacterial-derived extracellular vesicles to clinical stage
Bacterially derived extracellular vesicles (EVs) such as Outer Membrane Vesicles (OMVs) have emerged as an attractive new modality for both immunotherapy and as vectors for nucleotides and proteins.
Being a highly heterogenic biological, the translation from research to clinical use is not without challenges. Developing effective scalable manufacturing processes and qualified analytical methods meeting the CMC requirements of Good Manufacturing Practices (GMP) needs to follow a defined path.
About NorthX Biologics AB
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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