Automating a bioprocess step reduces process variation, increases productivity, prevents manual errors and frees up operator time, as well as improving health & safety and working conditions. The switch to automation of a final aseptic filtration and container fill step within a contract manufacturing environment is discussed by Dr Nick Hutchinson, Market Development Manager (Pharma & Biotech) at Parker domnick hunter.
Single-use technology allows for more rapid technology transfers by minimizing the time it takes to design, purchase and qualify new capital assets. Rapid turnover between batches is readily permitted without the need for protracted clean-in-place and steam-in-place regimes, while the risk of product cross contamination is reduced as single-use fluid contact surfaces will never have previously been exposed to a biopharmaceutical product.
Our client, FUJIFILM Diosynth Biotechnologies has biopharmaceutical contract manufacturing operations in the USA and UK. When they were designing their new mammalian cell culture manufacturing capacity at the UK site, decisions needed to be taken about the approach to final bulk filtration and filling into containers that would be adopted within the new facility.
Dr. Paul Bird, Head of the Manufacturing Engineering Group at FUJIFILM Diosynth Biotechnologies and project leader, adds “As CMO’s we are expected to develop, transfer and manufacture right first time to GMP (good manufacturing practices) and achieving this objective is a major undertaking requiring considerable planning.”
When implementing a single-use solution, various levels of automation are available from completely manual steps, through semi-automated to completely automated unit operations. The level of automation specified will depend on the step in question and the cost of implementation and ownership versus the technology transfer and operational improvements achievable. Final bulk filtration and filling into containers is the final step in the manufacturing process prior to the product being transported to the location where it will be put into vials.
Dr. Bird explains “While some would consider the final bulk filtration and container filling of the purified biopharmaceutical to be a relatively simple task when compared with, for example, a chromatography step, the considerable coordination of people, materials and methods generates operational complexities at the point in the process when the value of the product is at its greatest.”
In order to determine the appropriate level of automation required from the system, Parker domnick hunter worked with the client to consider all areas of uncertainty, including the precise time that the product will arrive in the filling suite, processing step factors being available and present in the suite while the process is running, and the availability of trained operators to perform the step with representatives from QA and QC always on hand to verify the operation and undertake dynamic environmental monitoring respectively. In addition, single-use consumables must have been delivered to the suite in advance of the product arriving from multiple suppliers while finally and not insignificantly, labels for the bulk product filled containers must be approved and released by the Quality department.
The collaboration with FUJIFILM Diosynth Biotechnologies led us to develop the SciLog® SciFlex® Filter and Dispense System, which performs an automated filtration, in-situ integrity test and container dispense.
Due to the high value of the product at this part of the process, the system is designed to maximize recovery of the product volume and provides teams at the site with a standard template for this unit operation that can be used for multiple processes.
To learn more about how automation of a single-use final bulk filtration step can enhance operational flexibility and facilitate compliant, right first time manufacturing with SciLog® SciFlex® Filter and Dispense, view Bird and Hutchinson’s webinar, Successful Implementation of Automation in Single-Use Bioprocessing.
This post is based on Bird and Hutchinson’s technical paper that will appear in BioProcess International Magazine’s Single-Use Supplement in March and was contributed by Nick Hutchinson, Market Development Manager (Pharma & Biotech), Parker domnick hunter Process Filtration, UK.
Combining unique and innovative SciLog® sensing and control technologies with renowned filtration expertise, Parker domnick hunter’s integrated and flexible automated single-use systems allow complete control of bioprocessing steps enabling consistent product quality. Visit our website to find out more about Parker domnick hunter’s single-use solutions.
Other Blog Postings: