Downstream Processing World Congress 2015

Guest blog: Is automation the key to consistent drug quality?

Dr Nick Hutchinson, Market Development Manager (Pharma & Biotech) at Parker domnick hunter reveals the origins of the SciLog® SciFlex® Filter and Dispense System, which will be showcased at this year’s Downstream Processing World Congress.

Automating a bioprocess step reduces variation, increases productivity, prevents manual errors and frees up operator time, as well as improving health & safety and working conditions.

This can be combined with single-use technology that 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.

FUJIFILM Diosynth Biotechnologies has biopharmaceutical contract manufacturing operations in the USA and UK. When Parker domnick hunter was 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.

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.

In determining the appropriate level of automation required from the system, all areas of uncertainty were considered, 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 Dr Paul Bird, Head of the Manufacturing Engineering Group, FUJIFILM Diosynth Biotechnologies and Dr Nick Hutchinson’s webinar, Successful Implementation of Automation in Single-Use Bioprocessing.

Daniela Buchmayr, Parker domnick hunter Business Development Manager will be speaking about the SciLog® SciFlex® Filter and Dispense System and Parker domnick hunter’s partnership with FUJIFILM Diosynth Biotechnologies, at Downstream Processing World Congress 2015.

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