WuXi Biologics adds 4,000L bioreactors at fully single-use site

The CMO says adding the single-use offering from ABEC will make the newly opened biomanufacturing site in China comparable to stainless steel for commercial mAb production.

HTTPS://WWW.BIOPHARMA-REPORTER.COM/ARTICLE/2018/03/21/WUXI-BIOLOGICS-ADDS-4-000L-BIOREACTORS-AT-FULLY-SINGLE-USE-SITE

WuXi Biologics to Install Industry’s Largest Single-Use Bioreactor from ABEC at its New Commercial Manufacturing Facility

WUXI, China and BETHLEHEM, PA, USA, March 20, 2018WuXi Biologics (2269.HK), a leading global open-access biologics technology platform company offering end-to-end solutions for biologics discovery, development and manufacturing, today announced that it has selected 4,000 liter (L) Custom Single Run (CSR®) disposable bioreactors from ABEC for its new commercial manufacturing facility (MFG4) in Wuxi city, Jiangsu, China. The partnership followed WuXi Biologics’ successful testing and evaluation of ABEC’s CSR bioreactor technology.

The 4,000L CSR is the largest single-use bioreactor size available in the industry and potentially largest-ever design in conventional disposable bioreactors, resulting in higher productivity and significantly lowering the cost of goods for cell culture-based biopharmaceuticals. The system also delivers performance comparable to stainless steel systems of that scale and can be fully customized for different products, resulting in higher cell culture productivity and faster process transfer and scale-up. With the scale-out strategy that WuXi Biologics pioneered in the industry to use multiple disposable bioreactors for commercial manufacturing, 4,000L CSRs will enable manufacturing up to the scale of 24,000L comparable to traditional stainless steel bioreactors yet still achieving the advantages of CAPEX and timeline reduction benefited from disposables.

Dr. Chris Chen, CEO of WuXi Biologics, said, “We are proud to be a global technology leader in bioprocessing and the first company in Asia to advance this exciting new technology. ABEC’s large volume single-use bioreactor greatly enhances our commercial manufacturing potential by allowing not only scale-out of capacity but also scale-up. In addition to the flexibility and time to market benefits of single-use manufacturing, we can now offer our clients true economies of scale and address biologics supply needs from kilograms to tons.”

“WuXi Biologics’ successful testing, evaluation and investment further validates ABEC’s CSR technology as one of the most flexible single-use solutions available on the market,” said Scott Pickering, ABEC President and CEO. “We are pleased to be part of their next-generation manufacturing strategy, and look forward to continuing this long-term partnership.”

About WuXi Biologics

WuXi Biologics, a Hong Kong-listed company, is the only open-access biologics technology platform in the world offering end-to-end solutions to empower organizations to discover develop and manufacture biologics from concept to commercial manufacturing. Our company history and achievements demonstrate our commitment to providing a truly ONE-stop service offering and value proposition to our global clients. For more information on WuXi Biologics, please visit www.wuxibiologics.com.

About ABEC

Since 1974, ABEC has been a leader in delivering integrated process solutions and services for manufacturing in the biopharmaceutical industry. A majority of the world’s pharmaceutical and biotech companies are ABEC customers with many of today’s leading therapies manufactured by processes and equipment engineered, manufactured, installed and serviced by ABEC. ABEC’s unique value is based on long experience, complete in-house capabilities, a custom, flexible approach, and long-term credibility. Whether adding capacity or improving existing facilities ABEC’s turn-key solutions and support services reduce overall cost and time to market while delivering maximum productivity. www.abecsingleuse.com.

Media Contacts:

WuXi Biologics
Jia Li
+86-21-2066-4528
li_jia0102@wuxiapptec.com

ABEC
Susan Cooper Curcio
+1 (610) 861 4666
scurcio@abec.com

Beyond mammalian culture: ABEC’s single-use range to cover microbial fermentation

Bioprocessing vendor ABEC has added microbial fermentation capabilities to its single-use line.

HTTPS://WWW.BIOPHARMA-REPORTER.COM/ARTICLE/2018/03/07/BEYOND-MAMMALIAN-CULTURE-ABEC-S-SINGLE-USE-RANGE-TO-COVER-MICROBIAL-FERMENTATION

ABEC Introduces Large-Scale Single-Use Microbial Fermentation Solutions to the Biopharmaceutical Manufacturing Industry

Custom Single Run (CSR®) process solutions set another new industry benchmark
 

Bethlehem, PA, USA, February 28, 2018 – ABEC, a leading global provider of integrated solutions and services for biopharmaceutical manufacturing, today announced large-scale single-use microbial fermentation capability. ABEC’s CSR technology has demonstrated state-of-the-art performance with working volumes up to 1,000 liters.

 

To date, implementing single-use microbial fermentation processes at large-scale has been challenging due to the high gassing rates, mixing power, and heat removal needed compared to mammalian cell culture processes. ABEC’s CSR Fermentation technology addresses these challenges and delivers performance at large-scale comparable to that of legacy stainless steel systems. ABEC is the only manufacturer of single-use bioreactors with capacity up to 4,000 liters and again, advances single-use bioprocess capability and production volumes with large-scale microbial fermentation technology.

 

“ABEC’s mission is to provide our customers with highly productive and cost-effective manufacturing solutions,” said Scott Pickering, ABEC President and CEO. “With the development of large-scale fermentation capability, ABEC continues to bring true economies of scale and process flexibility to single use bio-manufacturing.”

 

About ABEC

Since 1974, ABEC has been a global leader in delivering integrated process solutions and services for manufacturing in the biopharmaceutical industry. A majority of the world’s pharmaceutical and biotech companies are ABEC customers; with many of today’s leading therapies manufactured by processes and equipment engineered, manufactured, installed and serviced by ABEC. ABEC’s unique value is based on long experience, complete in-house capabilities, a custom flexible approach, and long-term credibility. Whether adding capacity or improving existing facilities, ABEC’s turn-key solutions and support services reduce overall cost and time to market while delivering maximum productivity. To learn more about ABEC, visit, http://www.abec.com, http://www.abecsingleuse.com, email info @abec.com and follow us on LinkedIn.

 

Media Contact:
Susan Curcio
Director of Marketing
scurcio@abec.com
+1 (610) 861 4666

ABEC Expands Manufacturing Capability of Single-Use Disposable Containers for Biopharmaceutical Manufacturing

ABEC establishes ISO-7 cleanroom at its European Headquarters, Fermoy, Co. Cork, Ireland, enhancing supply assurance for its global Custom Single Run (CSR®) customers 

Bethlehem, PA, February 13, 2018 ABEC, a leading global provider of integrated solutions and services for biopharmaceutical manufacturing, today announced the completion of its second ISO-7 cleanroom for single-use disposable container (DC) manufacturing. ABEC’s Bethlehem, Pennsylvania, USA, cleanroom has been fully operational since 2015, and the new Fermoy, Ireland, cleanroom will be operational this April, adding significant capacity while establishing supply redundancy for ABEC’s global CSR customers.

Complete, in-house DC manufacturing capability is a key element of ABEC’s single-use strategy, enabling ABEC to deliver customized DC’s globally that meet demanding quality and scheduling needs. Identical tooling and operational procedures at the two facilities ensure consistency of DC quality and performance. The CSR DC also utilizes non-proprietary, commercially available materials, instruments, and components, allowing customers to leverage existing qualification and validation efforts. These factors combine to provide customers with unprecedented control of single-use supply chains.

“A flexible and reliable supply of high quality DC’s is critical to our customers’ single-use manufacturing operations,” said Scott Pickering, ABEC President and CEO. “ABEC’s new state-of-the art cleanroom in Fermoy greatly enhances our DC supply capability and further reduces our customers’ single-use supply chain risk.”

Partners for ABEC’s cleanroom are: ClearSphere and Kingspan. Visit Cleanroom Technology Magazine for ClearSphere’s article Turnkey Solution for a Bespoke Cleanroom, published February, 2018, page 22-25.

About ABEC

Since 1974, ABEC has been a global leader in delivering integrated process solutions and services for manufacturing in the biopharmaceutical industry. A majority of the world’s pharmaceutical and biotech companies are ABEC customers; with many of today’s leading therapies manufactured by processes and equipment engineered, manufactured, installed and serviced by ABEC. ABEC’s unique value is based on long experience, complete in-house capabilities, a custom, flexible approach and long-term credibility. ABEC’s turn-key solutions and support services reduce overall cost and time to market while delivering maximum productivity. Visit www.abec.com, www.abecsingleuse.com, email info @abec.com , follow ABEC on LinkedIn.

Media Inquiries: scurcio@abec.com , +1 (610) 861 4666

Customised tech protects large single-use bags

By Flora Southey 

A pulley loading system and customised storage frame reduces damage risk to large single-use bags, says 4,000L bioreactor vendor ABEC.

https://www.biopharma-reporter.com/article/2017/11/17/abec-customised-tech-protects-large-single-use-bags

 

Emergent buys ABEC bioreactor to transfer raxibacumab to Baltimore facility

By Gareth Macdonald 

Bioterrorism countermeasure manufacturer Emergent Biosciences has bought a 4,000L bioreactor developed by ABEC.

https://www.biopharma-reporter.com/article/2017/10/27/emergent-buys-abec-bioreactor-to-transfer-raxibacumab-to-baltimore-facility

 

ABEC 4,000 Liter Single-Use Bioreactor to Expand Emergent

Emergent adopting ABEC Custom Single Run (CSR®) technology to increase flexibility and productivity.

 

Bethlehem, PA, USA, October 24, 2017- ABEC, a global provider of integrated solutions and services for biopharmaceutical manufacturing, today announced that Emergent BioSolutions will equip their Baltimore, Maryland bulk manufacturing facility (Bayview), designated a Center for Innovation in Advanced Development and Manufacturing (CIADM), with an ABEC 4,000L CSR bioreactor. The system will be custom designed to Emergent’s process needs, operational requirements, and facility constraints, and will greatly expand cell culture capacity at the Bayview site.

 

The 4,000L CSR is the largest single use bioreactor size available in the industry by a factor of two, resulting in approximately twice the productivity per floor space and lower cost of goods for cell culture-based biopharmaceuticals. The system can also deliver performance comparable to stainless steel systems and can be fully customized for different products, resulting in higher cell culture productivity and faster process transfer and scale-up.

 

Scott Battist, Emergent BioSolutions Vice President and General Manager of the Bayview site said, “The CIADM is designed to be a flexible, multi-product facility that cost-effectively addresses the diverse needs of our customers. ABEC’s CSR enables us to fully realize the benefits of single use technology by improving flexibility while leveraging economies of scale.”

 

“Emergent has been an ABEC customer for many years,” said Scott Pickering, ABEC President and CEO. “We are pleased that Emergent has chosen ABEC’s CSR technology to be part of their next-generation manufacturing strategy, and we look forward to continuing this long-term partnership.”

 

About ABEC

Since 1974, ABEC has been a leader in delivering integrated process solutions and services for manufacturing in the biopharmaceutical industry. A majority of the world’s pharmaceutical and biotech companies are ABEC customers with many of today’s leading therapies manufactured by processes and equipment engineered, manufactured, installed and serviced by ABEC. ABEC’s unique value is based on long experience, complete in-house capabilities, a custom, flexible approach, and long-term credibility. Whether adding capacity or improving existing facilities ABEC’s turn-key solutions and support services reduce overall cost and time to market while delivering maximum productivity. Visit: www.abec.com, www.abecsingleuse.com. Media Contact: Susan Cooper Curcio, Director of Marketing, scurcio@abec.com,+1 (610) 861 4666

Testing and Simulation Approaches for Single-Use Bioreactor Scale-up

Tools aid scale-up and comparison of single-use and stainless-steel bioreactors.

ABEC breaks the 2,000L ‘plastic ceiling’ with 4,900L single-use bioreactor

By Dan Stanton+, 12 Jul 2017

ABEC says its latest offering has twice the working volume of the 2,000L bioreactor systems generally deemed to be the upper limit in single-use bioprocessing.