“It takes 20 years to build a reputation and five minutes to ruin it”. Wise words from Warren Buffet.
And in biopharmaceutical manufacturing, these words certainly ring true.
Process variation or operator error in downstream processing can have huge consequences for biopharmaceutical manufacturers, CMOs (contract manufacturing organizations) and CDMOs (contract development and manufacturing organizations).
If a batch is lost due to contamination through human error, for instance, a manufacturer may not only suffer significant financial losses but more importantly, there may be a market shortage of life-changing drugs that patients depend on. The subsequent damage to a company’s reputation can be enormous.
To operate effectively and serve their customer bases, biopharmaceutical manufacturers, CMOs and CDMOs, therefore, need consistent, defined outcomes.
A bioprocessing system, such as Parker's SciLog® FD – which automates, standardizes and encloses final bulk filtration and dispense operations – removes the variability and potential for human error that is inherent in manual processes.
Using such a system allows manufacturers to apply pre-defined recipes for sterile filtration and/or dispensing. Stages such as sampling and product recovery are automated, while in-line pre and post-use filter integrity testing is built into the system. There’s a huge contrast between this scenario and that of an operator working in a high-stress, high-pressure situation, manually operating pumps and valves, while struggling to also read a balance.
A standardized, automated and enclosed single-use system has multiple benefits for manufacturers. These include:
According to GMP Annex 1, a risk in the operation of single-use systems is “an increase in number and complexity of manual operations and connections made”. Clearly, using an automated system reduces manual operations, while the single-use manifolds employed in the SciLog® FD System are designed to minimize the number of connections made. When compliance is a key consideration, an automated, standardized and enclosed system can provide a highly effective solution.
This post was contributed by David Heaney, market development manager, Parker Bioscience Filtration, UK
Parker Bioscience Filtration specializes in automating and controlling bioprocesses. By integrating sensory and automation technology into a process, a manufacturer can control the fluid more effectively ensuring the quality of the final product. Visit www.parker.com/bioscience to find out more.