Single-use technology is well-established, and has made its way into commercial licensed facilities, but there is more innovation in this field which will further enhance its versatility into new markets and technologies. The closed-system ballroom manufacturing approach will enable biomanufacturers to take full advantage of the flexibility offered by single-use systems, while driving out risk and is particularly suitable for applications that require multiple or rapid change-overs, and therapies with small scale production.
The concept of optionality is key to staying flexible in biomanufacturing by keeping your options open and having multiple pathways to take while navigating through this highly uncertain environment. Using a combination of financial options analysis and decision analytics to quantify your options helps to embrace the uncertainty equation.
Using data analytics to drive continuous improvements in efficiency.
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 biosimilars boom is expected and both biopharma and contract manufacturers want to be positioned to capture a piece of the market. ISR’s Biosimilars Manufacturing: Key Considerations and Expected Outsourcing Practices (4th Edition) goes into depth on one of the most important aspects of biosimilars: manufacturing.
Antibodies continue to dominate. Analyzing the strategies employed by successful players in the field could provide invaluable lessons for those hoping to enter it.
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.
Fast and efficient process development and scale-up contributes to a shortened time to market. 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.
Calculation examples that highlight scenarios where the enhanced capacity and alkaline‑stability of MabSelect PrismA can provide process economic benefits to large‑scale mAb processing.
I sat down with Kate Hammeke, VP of Industry Standard Research to discuss the biggest surprises or takeaways from this year’s report about the industry’s biologics and biosimilars manufacturing goals. But the conversation also evolved to some of the larger trends Hammeke expects to see impacting the biosimilar players in the future.
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