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 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

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.

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.”