It’s probably no surprise to many skilled practitioners that one of the major lean initiatives in bioprocessing is to improve throughput and reduce cycle time.
Apparently this is all very obvious but it’s really surprising how many manufacturing operations fall down over this relatively simple concept.
AND this applies equally to both clinical production as well as commercial manufacturing.
Very often there are points of failure in processes that are associated with variability at both the upstream and downstream ends of a process and this is frequently due to poor operational control. As a result, throughput falls due to the failures and extra “belt and braces” measures are often applied to “make sure” that the failures don’t re-occur. This has the effect of increasing the cycle time and reducing productivity.
A better strategy is to take a holistic approach and identify the roots causes and then make appropriate changes to prevent re-occurrence. Simple in concept but often hard in practice!
At the downstream chromatographic separations part of the process there are many areas which introduce variability into a process.
Here we provide some guidance on 7 key areas which are important for a successful Lean bioprocessing strategy.
1. Standardize the packing of the columns using a very tight and monitored procedure. Only use experienced staff to perform this function.
2. Make sure that the system suitability is established and running in a stable mode before running product through the process
3. Establish error proofing measures for the operation of the equipment which should include mistake proofing valving arrangements etc
4. Make sure there is tight procedural control of the preparation of the elution buffers used in the separation process.
5. Establish standardized loading patterns for the columns
6. Establish cleaning and maintenance protocols for the columns and assure that they are followed rigorously.
7. Establish outstanding operator training programs and spend the effort to re-certify staff on a regular basis, especially when campaigning has been suspended for any length of time.