Thursday, July 2, 2015

Single-use technologies enable closed-system bioprocessing

The benefits of single-use technology
Single-use technologies provide a number of benefits over traditional hard-piped equipment and facilities. Five key benefits are described below:
1.    Increased flexibility which allow system changes to be readily implemented during process development, scale-up or while a process is in routine operation.
2.    Reduced risk of contaminations either between batches of the same product or between batches of different products manufactured in the same facility
3.    Reduced or eliminated need for steam-in-place and clean-in-place generating equipment
4.    Shorter facility start-up time
5.    No need for cleaning validation
However, an additional benefit that is attracting an increasing amount of attention is the utilization of single-use technologies to allow closed-system processing.
Why perform closed system processing?
Closed-system processing in single-use technology might be an attractive option for a range of biomanufacturers with different motives. These could include:
·         Cell Therapy manufacturers operating short and simple processes with no method of sterilizing their end-product
·         Vaccine and viral vector manufacturers who find that sterile filtration processes significantly reduce process yields of these large biologics
·         Continuous manufacturers operating processes for many weeks at a time and wanting to avoid a build-up of bioburden within their equipment
·         Any biomanufacturer looking to cut facility running costs by reducing the air handling requirements within processing suites
·         Small-scale, localized, temporary bioproduction facilities manufacturing vaccines close to outbreaks of infectious diseases where local infrastructure is limiting.
Single-use developments allowing for closed-system processing
Pre-irradiated, assembled manifolds and containers are available from a range of suppliers. Operators simply need to install the product-contact consumable and are then ready to start processing.
Single-use bioreactors have been available for some time and are designed, of course, to minimise the risk of microbial ingress. Similarly, single-use mixers and bioprocess containers can be connected to and from with sterile connectors. Sterile disconnectors allow ancillary tubing to be removed while maintaining a sterile boundary around the product. Thermoplastic elastomer tubing can be welded to create flowpaths without compromising sterility and can be sealed to close containers.
The sterilization of product streams and necessary process solutions such as culture media and buffers can be achieved using gamma-irradiated membrane filter capsules. Remember, however, that simply used a sterilizing-grade filter in itself does not guarantee sterility and that validation of the sterile filtration process must be performed to ensure a bioburden-free environment.
For a while, closed-system processing was held back by a lack of suitable technologies for the purification of biologics largely because the need had not been identified or the technology not available. The company I work for has now launched a single-use TFF which avoids the need to clean and store cassettes. At a conference I attended last week Dr James Rusche, Senior VP Research & Development at Repligen described a single-use Protein A chromatography column that had been gamma-irradiated to prevent the build-up of bioburden during continuous harvesting operations.
Of course, because a technology can be gamma-irradiated does not mean it is qualified as sterile, however, if the drivers are there then customers will push vendours to generate this data for all single-use technologies allowing closed-system processing to become a reality for a growing number of processes.
Have your say
Are you driving towards closed system processing? What technology would, if available, make operating in this way more feasible?

Want more on single-use technologies? Meet leading companies in the space at BioProcess International Conference & Exhibition this fall in Boston. Here are the sponsors and exhibitors that will be attending:

Finesse Solutions, Inc.
GE Healthcare Life Sciences
JSR Life Sciences
Meissner Filtraion Products
Optek-Danulat Inc.
Pneumatic Scale Angelus
ILC Dover
Pall Life Sciences
Nordson Medical
Thermo Fisher Scientific
Beckman Coulter
em-tec Flow Technology (LP)
Kuhner Shaker Inc.
WR Grace

Dr Nick Hutchinson

Join me at #BPIconf
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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1 comment :

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