Next Generation Bioprocessing and the Implications for Viral Safety
With many companies embracing the move to next generation bioprocessing, it is important that they do not forget to re-examine their approach to viral safety.
Kathy Remington, Michael Phillips |
sponsored by MilliporeSigma
Biomanufacturers are heralding next generation bioprocessing as a way to improve efficiency and productivity, reduce plant footprint and operating costs while maintaining the highest quality standards for the therapies being produced. Compared to traditional batch processing, this new manufacturing paradigm may include higher concentration fluids, higher mass loading of individual unit operations, longer duration processes and connected or continuous processes.
However, maximizing the benefits of this new approach to manufacturing requires consideration of the entire process from a holistic perspective. For example, process intensification using perfusion methodologies results in high density cell cultures that maximize protein productivity in relatively small bioreactors. While this can compress upstream timelines and increase protein yields per unit volume from the bioreactor, downstream operations may struggle to keep pace with higher titers from improved upstream operations.
It is clear that from a process development perspective, we need to consider the implications of efficiency improvements in a single operation in the context of the overall process. Overlaid on this, we may need to rethink how these changes might impact viral safety and how we assess the clearance capabilities of the individual operations.
Read the full article now
Log in or register to read this article in full and gain access to The Medicine Maker’s entire content archive. It’s FREE and always will be!
Or register now - it’s free and always will be!
You will benefit from:
- Unlimited access to ALL articles
- News, interviews & opinions from leading industry experts
- Receive print (and PDF) copies of The Medicine Maker magazine
Or Login via Social Media
By clicking on any of the above social media links, you are agreeing to our Privacy Notice.