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 post. The 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?
Join me at #BPIconf
Contact me at nick.hutchinson@parker.com
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.
|
Share this article with your social network, just click below to share now!
|
|
|
No comments :
Post a Comment