Securing the right plasmid for an application can be a complex endeavor. Core to this is selecting a supplier with the quality assurance protocols and GMPs to facilitate optimized plasmid production.
The ability of viral vectors to target specific cells has made them a promising treatment modality to emerge in recent years, but the specificity enabled by this tropism has created complexities impacting their scale-up. Ensuring optimal yield for engineered viral vectors early in a process is crucial to ensuring their eventual commercial viability and broader patient accessibility.
Manufacturers remain challenged to quickly implement new technologies for products in late-stage development. A clear path for establishing equivalency is needed to facilitate more rapid advances and ultimately enable lower-cost gene therapies that reach patients faster than ever.
cGMP outlines safety procedures for every basic part of production - defining what needs to be done to keep products safe, operate machinery properly, validate processes, and maintain consistent procedures.
For this innovative biotech, the patient always comes first. With over 15 years of experience in gene therapy research, Andelyn Biosciences brings pioneering solutions that turn hope into reality.
