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:

Eppendrof
Finesse Solutions, Inc.
GE Healthcare Life Sciences
JSR Life Sciences
Levitronix,
Meissner Filtraion Products
Optek-Danulat Inc.
Qosina
Repligen
Saint-Gobain
SpectrumLabs.com
Pneumatic Scale Angelus
ILC Dover
CPC
Pall Life Sciences
TEK
Nordson Medical
Thermo Fisher Scientific
Beckman Coulter
em-tec Flow Technology (LP)
Kuhner Shaker Inc.
Entegris
WR Grace

Dr Nick Hutchinson

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.

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Biopharmaceutical Development & Production Week 2015 > Call for Speakers

Biopharmaceutical Development and Production Week 2015 will be the most in-depth and comprehensive concept-to-commercialization experience for professionals dedicated to the advancement of next-generation biologics via manufacturing facilities of the future. And for the first time, BPD Week will also incorporate IBC’s Single-Use Applications and Flexible Facilities conferences into the event. Take a greater role in this community, add to your professional accomplishments, and help shape the future of the field by presenting a talk at BDP Week.

BioPharmaceutical Development and Production Week will take place March 30-April 2, 2015 in Huntington Beach, California.

Speaker proposals are being accepted now through October 27, 2014.
>> Submit your speaking proposal here.

If you are working in any of the following scientific/business topic areas, we encourage you to submit a proposal for a podium presentation. We are especially looking for case studies with unpublished data on the following:

• • Manufacturing Efficiencies: Strategy & Technology
• • Upstream Processing
• • Downstream Processing
• • Antibody Drug Conjugate Development & Production
• • Engineering (Single-Use and Flexible Facilities)
• • Analytical
• • Process Validation
• • Viral Safety
• • Raw Materials and Supply Chain

To go in-depth on what we’re looking for in each of these categories, visit our webpage.

How else can you get involved in BDP Week?

• • We’re also accepting abstracts for posters. Showcase your research by submitting your poster.
• • We’re also currently recruiting sponsors and exhibitors. Each year, BDP Week debuts as the first must attend event for biopharmaceutical professionals from around the globe. Now is the time, to work with IBC to develop a customized, integrated marketing program that features pre-, post- and on-site solutions that help increase your market reach and influence – before, during and after the event. Request more information. 
• • You can also join us as an attendee.  Registration is currently open and you can save up to $450 off the current rate.  

Have any questions? Feel free to reach out Jennifer Pereira.

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Single-Use Tech: Four Facts to Impress Your Colleagues

This post was authored by Mike Madarasz of the Institute for International Research.  You can follow him on Twitter at @MikeMadarasz

The verdict is on the environmental effects of single-use technology in comparison to stainless steel.  We now have a good grasp on this topic and all signs point to single-use systems impacting the surrounding environment to a much lesser extent than re-useable technologies.  BioProcess International recently took a close look at some of the sustainability issues associated with single-use processes.  Here are four facts you can use to impress your colleagues the next time this conversation comes up:

·       -  A single-use technology facility uses about 50% less energy than one based in stainless steel.  This is largely due to the amount of energy required to heat processed water in sterilizing reusable equipment. 

·      -  Some studies suggest that adopting a single-use system results in a reduction of about 85% of both water usage and waste generation from that of stainless steel.

·      -  One study shows that energy demand and global warming potential with single-use systems is 30-35% lower than stainless steel systems over the full manufacturing life of the facility.

·      -  As far the different types of environmental impacts associated with single-use, 22 different categories have been identified. 

How can single-use technology become improve on its environmental impact? One idea is to reduce the impact of disposable plastic containers used in these processes. The most common solution there appears to be finding ways to repurpose and recycle that plastic rather than letting it amount to waste.

Any other ideas on improving sustainability?

You can check out the full article from BPI here.

We’ve got much more on single-use systems. Check out Single-UseApplications for Biopharmaceutical Manufacturing. June 9-10, Boston MA

Register now and SAVE 20%. Use code XB14187BLOG

Follow us on Twitter @FutureBioPharma

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Single Use Session Spotlight: Single-Use Process Fit for mAb Production

Applying single-use technology has shown to lower costs and increase yield. How? Merck & Co., Inc. completed an end-to-end process fit using single-used technology for the production of monoclonal antibodies. Gain insights on single-use technology versus traditional stainless steel for process fits and facility designs. Dr. Jeffrey Johnson will be joining us at the Single-Use Applications Summit for Biopharmaceutical Manufacturing to present Single-Use Process Fit for mAb Production this June in Durham, North Carolina.

For more information on this session and the rest of the program, download the agenda. If you'd like to join us June 3-5, 2013, in Durham, North Carolina, as a reader of this blog when you register to join us and mention code SU13JP, you'll save 20% off the standard rate!

Featured Session:  Single-Use Process Fit for mAb Production

Featured Speaker: Jeffrey Johnson, MS, New Technology Lead, Merck & Co

About the session: A complete process fit for end to end single use production of monoclonal antibodies will be presented. The evaluation includes a comparison of stainless steel and SU facilities, with capital estimates and total cost of ownership assessments, and NPV modeling. Sensitivity analysis will be demonstrated using single use equipment evaluated at lab or pilot scale. This in depth evaluation will provide insight into single use vs. traditional stainless steel process fits and facility designs.

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