Through proper planning of your automation integration, you can eliminate costly errors and missteps and focus on developing efficient, future-proof automation strategies.
Complete transparency and open communication are both critical for a successful partnership. What business practices should you look for to ensure your CDMO can offer this type of commitment?
How to understand and prepare for challenges early in development to avoid bottlenecks that significantly slow production and delay a drug’s time to market.
Current state-of-the-art continuous manufacturing technologies are being developed and implemented to manufacture a wide variety of products including monoclonal antibodies, recombinant proteins, and other biological modalities. Though upstream fed batch and perfusion bioreactors unit processes are relatively mature, downstream process unit operations are less mature. In this case study, Catalent compared the productivity of purifications running in batch versus continuous mode.
Critical quality attributes (CQA) are fundamental to regulatory compliance and in drug development and manufacturing. Find out how surface plasmon resonance has been applied for protein characterization of antibody effector function.
The biosimilars market is suddenly booming, with established biopharma giants and nimble start-ups all clamoring for a piece of the action. But such steep competition means that only the wise will survive.
Before you sign on the dotted line, do a little digging to unearth potential costs that could turn your development program into a cash-burning exercise.
This application note demonstrates a multidimensional scale-up (change of both column diameter and bed height) of a mAb capture step, using the ÄKTA pilot 600 chromatography system.
Polysorbate-80 (PS-80) is a surfactant commonly used as an excipient to improve API stability. However, degradation of PS-80 can lead to decreased drug potency or stability, and there is inconsistency in the quality and composition of PS-80 provided by different vendors.
Concerns about leachables were expected to restrict adoption of single-use systems. This case study shows how far they’ve come.
|
|
|
|
|
|
|
|
|