Monday, August 3, 2015

Increasing the flexibility of fill finish operations with single-use technology

There are many benefits to using single-use technology for the manufacture of biopharmaceuticals. The enabling aspect of the technology that allows closed-system processing has been examined in a previous postThe single-use principle can be applied across the biomanufacturing process with bioreactors, chromatography and cross flow filtration all available in single-use formats.

Single-Use and Fill Finish

The role of single-use in adding flexibility to fill finish operations will be the subject of a presentation given by Chris Smalley, Ph.D., from Merck & Co. at the Bioprocess International 2015 Conference that will be held in Boston in October. Chris’presentation will be part of the ‘Drug Product Manufacturing & Fill-Finish Processing’ track which is new for this year.

In a recent interview, Chris highlighted the fact that single-use technologies can play an important role in helping to rapidly establish global networks of fill finish operations. These are required in order to meet emerging demands (Merck Champions Single-Use ByAddressing Emotion Vs. Science, by Trisha Gladd at Bioprocess Online)

One way of developing such a network will be to utilize existing manufacturing locations and staff. Minimizing the amount of work required to redevelop these existing facilities around the world will be crucial in achieving the level of operational agility that will likely be required. Taking a single-use approach to fill finish will allow this by reducing the need for HVAC, cleanrooms and WFI systems. The affordability of drugs can be improved as the capital costs, labor requirements and time needed to design and build new facilities will be reduced.

Particulates and Extractables

In the article, Smalley addresses two common concerns about single-use technologies that are particularly pertinent during fill finish operations, namely, particulates and extractables. These are especially important issues for fill finish because there are no further processing steps that can remove impurities derived from equipment or consumables at this stage in the process. Smalley believes that the available studies show that there is little or no risk to patients from particulates and he is an advocate of suppliers providing adopting the BPOG guidelines with respect to extractables.

To facilitate the implementation of single-use across the company, Merck have a Single-Use Network (SUN) of advocates that set guidelines and define good practices. Smalley sees standardization as a key success factor for single-use implementation within the industry. He will no doubt be interested in participating in the Town Hall Forum Discussion on single-use technologies with industry organizations such as BPSA, BPOG, PDA, ASME BPE and ASTM.

Have your say

To what extent do you think challenges, such as particulates and extractables, relating to the implementation of single-use technologies can be overcome?

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Dr Nick Hutchinson has a Masters and Doctorate in Biochemical Engineering from University College London, UK where he focused on laboratory tools for rapid bioprocess development and characterization. He then worked at Lonza Biologics in an R&D function investigating novel methods for large-scale antibody purification before moving to an operational role scaling-up and transferring manufacturing processes between Lonza sites in the UK, Spain and USA. Nick now works in Market Development at Parker domnick hunter where his focus is in bringing Parker's strengths in Motion & Control to Bioprocessing. This will enable customers to improve the quality and deliverability of existing and future biopharmaceuticals.

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