22nd November 2018
PAT, Biopharma and Microsaic
Wouldn’t it be nice if we were older, then we wouldn’t have to wait so long?…
Or so sang the Beach Boys in 1966.
…Wouldn’t it be nice to control the quality of the product right from the start of your manufacturing process?
Instead of waiting for the finished article to roll off the production line to perform quality verification, why not assess quality in real time and at all stages of the manufacturing process? This is the rationale behind process analytical technology (PAT). PAT is well established within pharmaceuticals. But it is now steadily gaining traction in Biopharma, where stringent processes are required for ‘quality by design’ (QbD). PAT in bioprocessing were discussed by our Chief Technologist Richard Moseley in a recent BioPharm publication. But how exactly do Microsaic and point-of-need mass detection fit in with PAT?
Real-time mass detection <=> PAT
Mass spectrometry (MS) is a wholly deterministic analytical technique, already widely adopted through-out the biopharma value chain and is increasingly being used in off-line (lab-based) bioprocessing analytics. However, the high infrastructure requirements of traditional MS instruments prevent their deployment on-line or at-line to collect real-time data. The Microsaic MiD® range of mass spectrometers are well placed for this emerging at-line and on-line markets, and as a valuable tool in PAT. The Microsaic MS is easily integrated into the bioprocessing workflow, driven by three key design considerations:
- Small footprint. Many so-called compact mass spectrometers boast a small footprint but forget to mention the surrounding supporting infrastructure, such as dedicated bench-space, an air-conditioned lab, or fixed Nitrogen supply. The Microsaic MiD® has no floor pump (we are often being mistaken as a part of the LC-stack!), no large exhaust, and has significantly reduced Nitrogen demand!
- Ease of use. A widely used term these days. Often, we find that many contemporary MS instruments are designed for ease of use as an afterthought, as complex high-end systems are somehow “dumbed down” but are still complex at heart. Microsaic’s design ethos adopts ease of use at its core, from its non-align, tool-free, plug-and-play front end, through to its simple software.
- Ease of install and maintenance. Out of the box and providing the user with analyses within an hour. Cleaning the front-end in under five minutes. Routine maintenance in under a day. No other MS can truly boast such benefits.
Recent development at Microsaic has produced developmental point-of-need mass spectrometers for PAT bioprocessing applications. Based on Microsaic’s propriety technology and with a mass range of up to 3,200 m/z the MS is suitable for deployment at any stage of the biologic production process. Information rich data is obtainable about the proteins and small molecules seen in a complex biological sample. For demonstration of this capability please see our application notes page, showing a range of applications, including real-time monitoring of typical components seen in bioreactors, in particular:
- Learn how we can monitor cell media and feedstocks
- Take a look at how our patented Protein Mass software provides simple pass/fail criteria
- See how your PAT can be boosted with analysis which measures small and large molecules, real-time
We showcase the benefit of having point of need MS in your (on-line/ at-line) bioprocess and the potential it can offer to the PAT market in our Application Note.
Perhaps we don’t have to be older, nor wait so long, after all!
Watch this space for more as Microsaic breaks new ground!