Emergent BioSolutions Expands Manufacturing Capability with ABEC Dual Purpose Single-Use Microbial Fermentation / Mammalian Cell Culture Systems

ABEC’s Custom Single Run (CSR®) systems to enhance Emergent BioSolutions’ manufacturing productivity, flexibility and economies of scale

Bethlehem, PA, USA September 24, 2018 ABEC, a global provider of integrated solutions and services for biopharmaceutical manufacturing, today announced the shipment of Emergent BioSolutions’ CSR dual purpose single-use systems for large scale 750L microbial fermentation and 500L mammalian cell culture. The dual purpose systems are custom designed to accommodate Emergent’s process needs and operational requirements and complement Emergent’s 4,000L CSR single-use bioreactor capability.

Integration of ABEC’s CSR dual purpose systems significantly advances Emergent’s commercial operations capabilities. Emergent can utilize the same equipment platform to provide multi-product, multi-platform and multi-scale manufacturing.  This includes the ability to utilize the same CSR platform for microbial and cell culture. Changeover from microbial processing to mammalian and vice versa is accomplished simply by changing the Disposable Container (DC) used for these processes. The systems also deliver process performance comparable to stainless steel systems, a key benefit of the CSR platform. In particular, Emergent is now able to achieve the vigorous mixing and high gassing rates required for state-of-the-art microbial fermentation in a large-scale single-use system.

“Emergent’s diverse customers require both mammalian and microbial processes to produce a wide variety of vaccines and therapeutics,” said Scott Battist, Emergent BioSolutions Vice President and General Manager of the Bayview site, “We are now able to quickly and cost-effectively provide manufacturing services utilizing either of these technologies.”

“We are proud of our contributions to Emergent’s advanced manufacturing capabilities,” said Scott Pickering, ABEC President and CEO. “The CSR dual purpose and microbial products are unique in the industry and further demonstrate ABEC’s long-term industry leadership and commitment.”

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. 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. http://www.abec.com, http://www.abecsingleuse.com; follow us on LinkedIn.

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

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

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

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

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

ABEC Sets a New Benchmark in Single Use Bioreactor Capacity

ABEC increases the maximum capacity of its Custom Single Run (CSR®) Bioreactors to 4,000 liters, doubling the industry standard

ABEC, a leading global provider of integrated solutions and services for biopharmaceutical manufacturing, today announced the release of single use bioreactors with production volumes of 4,000 liters. ABEC’s 4,000 liter CSR Bioreactor has demonstrated performance comparable to stainless steel systems, a key feature of the CSR product line.

ABEC is the only supplier able to provide single use bioreactors with capacities greater than 2,000 liters. The 4,000 liter capability enables significant reduction in capital, facility, and disposables cost by doubling cell culture capacity in approximately the same floor space. The number of systems and disposable containers needed is cut in half, and facility size is reduced.

“The 4,000 liter capability is consistent with ABEC’s mission to provide the industry’s most productive and costeffective solutions for biopharmaceutical manufacturing. Rather than incur the costs needed to ‘scale-out’ capacity with multiple 2,000 liter systems, single use customers can now achieve true economies of scale ,” said Scott Pickering, ABEC President and CEO.

 

Custom Single Run (CSR)

ABEC’s CSR product line is a new paradigm for single use implementation. Leveraging ABEC’s long experience in equipment design, our customized approach, and our exclusive focus on production scale bioprocessing, CSR sets new benchmarks in single use productivity, cost, and flexibility. Key features include the industry’s largest production volumes, performance comparable to stainless steel systems, seamless process transfer and scale-up, rapid container loading, and a non-proprietary supply chain.

ABEC Single Use Bioreactor Demonstrates Process Scalability at a Major Biopharmaceutical Manufacturer

ABEC’s Custom Single Run™ (CSR™) Bioreactor enables seamless scale up and transfer of cell culture processes

ABEC, a leading global provider of integrated process solutions and services for biopharmaceutical manufacturing, today announced a successful demonstration of their Custom Single Run™ (CSR™) Bioreactor at a confidential biotech client. ABEC delivered a CSR Bioreactor custom designed to match the performance of the client’s large-scale stainless steel production bioreactors. The CSR Bioreactor showed equivalent process performance, greatly simplifying the client’s scale-up and transfer of new products from development to production.

Scale-up and transfer of cell culture processes from single use bioreactors can be challenging. The single use bioreactors currently on the market are standardized systems with little or no design flexibility to accommodate specific process needs. Performance of these systems can also degrade at larger scale. Process transfer and scale-up can therefore require significant development effort and/or compromises to performance.

CSR is a unique paradigm for single use implementation. Systems can be custom-engineered for optimum process performance, greatly simplifying scale-up and transfer. For this effort, ABEC determined the baseline blending and mass transfer characteristics of the client’s stainless steel production bioreactors, and delivered a 200L CSR Bioreactor engineered for equivalent performance. The 200L CSR not only demonstrated equal or better oxygen transfer rates (OTR) and blend times, but also equivalent viable cell density and product titer.

“This collaboration provided our client with a clear path for rapid scale-up of more than 10x in volume as well as seamless transfer of cell culture processes across different sites and between stainless steel and single use platforms,” said Scott Pickering, ABEC President and CEO. “We are pleased that our innovative CSR approach is demonstrating genuine value to our clients.”

Visit with ABEC (Stand #3759 & #3760) March 21-23, Interphex 2017, Javits Convention Center, NYC.

ABEC Introduces the Industry’s Largest Disposable Mixing Systems

ABEC today announced the extension of its Custom Single Run™ (CSR™) product line for scalable single use manufacturing of biopharmaceuticals. ABEC’s CSR-General Mixing products offer custom fluid preparation and hold capabilities up to 5,000 liters – approximately doubling the capacities currently available in the industry. ABEC has previously introduced the largest single use cell culture bioreactors in the industry (3,500 liters). ABEC will be showcasing this technology at the annual Interphex show (booth #3759) in New York April 26-28.

The CSR-General Mixing products extend ABEC’s single use capabilities across the entire bioprocess – applications include Cell Culture Harvest, Purification Pooling, and Viral Inactivation. Consistent with the overall CSR product strategy, the CSR-General Mixing systems deliver process performance comparable to stainless steel systems. ABEC has developed a unique mechanically-driven mixer that achieves the shortest fluid blending times of any disposable mixing system on the market.

ABEC CEO Scott Pickering said: “With the addition of the CSR-General Mixing systems, ABEC is enabling complete upstream and downstream large scale processing, thereby setting a new benchmark in single use facility productivity. With scalable performance and larger batch capability, biopharmaceutical manufacturers can realize lower cost of goods and true multi-product flexibility in these facilities.”

 

About Custom Single Run™ (CSR™)

CSR is a new paradigm in single use processing that addresses the unmet needs in commercial biopharmaceutical manufacturing. In contrast to the standard “off-the-shelf” systems currently on the market, the CSR products are fully customizable, deliver performance comparable to stainless steel systems, provide the largest batch sizes, are designed for manufacturing productivity, offer unprecedented supply chain transparency, and utilize only commercially available, nonproprietary materials, components, and control systems. CSR fulfils the promise of single use manufacturing with true multi-product flexibility, lower cost of goods, reduced supply chain risk, and higher equipment productivity.

ABEC Introduces the Industry’s Largest Single Use Bioreactors

ABEC today announced the completion of testing and release to market of its large scale Custom Single Run™ (CSR™) Bioreactor train. The train includes a 3,500 liter working volume (4,300 liter total volume) production bioreactor, the largest single use bioreactor available in the industry.

The CSR™ Bioreactor product line can be custom engineered for any working volume in the range of 50 liters to 3,500 liters. Consistent with the key CSR™ benefit of process scalability, the 3,500 liter volume nearly doubles the current state of the art, while delivering performance comparable to stainless steel systems. In contrast, other disposable bioreactors currently on the market top out at ≤ 2,000 liters, generally with poorer mixing and mass transfer performance compared to stainless steel systems. As such, the 3,500 liter CSR™ can deliver significantly more product per square foot of floor space; a key metric in high value multiproduct biopharmaceutical manufacturing facilities.

Given ABEC’s long history in engineering systems for commercial scale manufacturing, the CSR™ Bioreactor products are also specifically designed for ease of use and high reliability. Packaging and loading of CSR™ Disposable Containers (DC’s) has been simplified for faster turnaround and lower risk of damage. Additionally, ABEC has taken steps to further reduce production risk by establishing complete in-house DC manufacturing capability with full supply chain transparency, as announced earlier this year.

Commenting on today’s announcement ABEC’s CEO Scott Pickering said: “ABEC is committed to providing complete single use, multiuse, and hybrid solutions that enable production. Our large-scale CSR™ Bioreactor capability further demonstrates ABEC’s focus on addressing shortcomings in current single use technology that have limited its adoption for commercial manufacturing.”

ABEC, Inc. Establishes In-House Disposable Container Manufacturing for Custom Single Run™ Product Line

ABEC, Inc. today unveiled manufacturing capability for single use Disposable Containers (DC’s) to support its Custom Single Run™ (CSR™) product line. DC manufacturing is currently underway in an ISO-7 cleanroom. ABEC will be showcasing this capability at the annual Interphex show (Booth #3759) in New York City April 21-23.

Key benefits of the CSR™ product line include state-of-theart process performance at scale and a lower risk DC supply strategy. In-house manufacturing capability enables efficient production of custom DC’s that meet exact process requirements and full control of quality and lead times. The capability also supports ABEC’s strategy of providing customers an unprecedented level of DC supply chain transparency and control.

Commenting on today’s announcement ABEC’s CEO Scott Pickering said: “ABEC’s ability to provide custom manufacturing-scale solutions on multiple platforms – single use, multi-use, and hybrid – is unique in the industry. DC manufacturing capability significantly strengthens our ability to engineer, design, and deliver optimal solutions that meet our customers’ overall business needs with respect to process performance, operational requirements, facility constraints, budgetary factors, and time to market.”