CMOs are positioned to play a leading role in standardizing control strategies for gene therapy because so many gene therapy products are funneled through CMOs for commercial scale production.
Using its Supplier Relationship Excellence (SRE) program, Amgen opened the lines of communication with suppliers and created a feedback loop where data can be shared to better understand operational performance.
A number of challenges are hindering efforts to develop cell and gene therapies to treat rare diseases. While these challenges may seem common across other drug markets, in the case of rare diseases, they are exacerbated by limited patient populations
Several drivers affect how the appropriate facility design and unit operations for a process are selected, making it imperative to properly evaluate each option.
The performance of two assays for determination of adenovirus concentration based on surface plasmon resonance (SPR) is demonstrated in this application note.
Here, we describe the development of two effective downstream processes for purification of adenovirus from cell culture harvest.
Here we describe screening of detergents for release of adenovirus from HEK293 host cells to replace the traditionally used detergent Triton™.
This application note describes the production of adenovirus in HEK293 cells cultured in HyClone™ CDM4HEK293 culture medium.
Cell therapy manufacturing has been a complex, challenging and costly process, but a new manufacturing solution seeks to change that
Digitally enabled cryogenic cold chain technology can now deliver the raw materials needed to manufacture cellular therapies