2016 BioProcess International Award Winners – Downstream and Facilities


At this year’s Boston Biotech Week the 2016 BioProcess International Award Winners were announced. These awards recognize outstanding achievements in the area of biotherapeutic development and manufacturing processes. This year individuals and companies that made significant contributions to improving biotherapeutics were recognized. Novel technologies in upstream, downstream and analytical application areas were also awarded. I have listed the winners and finalists along with a brief description of the winning achievements for downstream technologies here. For a list of upstream and analytical technology winners, please see 2016 BioProcess International Award Winners – Upstream and Analytical.

Category – Best Technology Application – Downstream

Winner: Pall Life Sciences’ Cadence Acoustic Separator

“The Cadence Acoustic Separator provides a novel scalable single-use technology for cell culture clarification based on an acoustophoretic separation. Acoustic wave separation (AWS) technology involves the use of low frequency acoustic forces to generate a 3 dimensional standing wave across a flow channel. Cell culture from a fed batch bioreactor enters the flow channel, and as the cells pass through the 3D standing wave they are trapped by the acoustic forces. The trapped cells migrate to the nodes of the standing wave, and begin to clump together till such time as their buoyancy decreases and they settle out of the suspension by gravity After separation of cells and cell debris, the permeate from Cadence Acoustic Separator shows a significant reduction in turbidity and reduces the area requirements for secondary clarification using depth filtration and subsequent filtration for bioburden control.”

For more information about the Cadence Acoustic Separator, please see our article – “Clarification using Acoustic Wave Separation offers Advantages including -Continuous Process Solution.”

Finalists

Puridify – FibroSelect

“Puridify’s platform purification technology, FibroSelect, aims to enable new processing strategies through significant advantages across key performance attributes, improving process flexibility and robustness, and meeting the industry demands of today and as the market evolves. FibroSelect adsorbents from Puridify have the potential to enable disposable product capture purification at industrial scale by vastly improving productivity. The FibroSelect material exhibits a novel proprietary structure that overcomes the diffusional and flow limitations of packed bed chromatography purification systems and the capacity issues of chromatography membranes. It also addresses the process robustness issues of predicting scaled performance due to the material’s fixed structure, which exhibits uniform purification performance at all scales. This, in combination with its macroporosity, also gives it strong potential as an enabling technology for the purification of next generation macromolecular biotherapeutics such as gene therapies, viral vectors and fusion proteins.”

For more information about FibroSelect please see our article – “Boston Biotech Week 2016 – Downstream Coverage – In case you missed it!”

Sanofi – Accelerated Seamless Antibody Purification (ASAP)

“ASAP (Accelerated Seamless Antibody Purification) is a sanofi-owned platform for continuous purification of mAbs (patent pending). ASAP was developed in the Bioprocess Science and Technologies department (Sanofi Vitry sur Seine, France), enabling to run three chromatography steps in continuous mode with no holding time nor open phase, including virus inactivation. This means that a cell culture bulk containing the Monoclonal Antibody can be fully and continuously processed to obtain a pure Monoclonal Antibody batch without any human intervention, decreasing process duration, resin and buffer costs. Dynamic evolution of ASAP already includes the use of membrane chromatography instead of conventional resins leading further improvement of productivity.”

Category – Best Collaboration

Winner: Puridify/GlaxoSmithKline  – FibroSelect for Industrial Use

“GSK and Puridifiy have been in a highly complementary collaboration for the past 12 months developing and evaluating the FibroSelect technology from microliter to 50L pilot scale and in the process have shared knowledge, industrial processing concepts and novel ideas. This initial collaboration has been successful in proving a 50-fold increase in purification productivity and has been extended for a further 18 months to drive towards full industrial scale purifying feed from >500L bioreactors.”

For more information about FibroSelect please see our article – “Boston Biotech Week 2016 – Downstream Coverage – In case you missed it!”

Finalists

G-CON/GEA Pharma Systems/Pfizer – The PCMM Consortium

Pall Life Sciences/FloDesign  – Disruptive Cadence Acoustic Separator

Category – Excellence in Facility Design or Retrofit

Winner: JHL Biotech – Installation of KUBio Biomanufacturing Solution

“The JHL Wuhan China manufacturing facility has been designed to support the manufacture up to 100kg of monoclonal antibodies per year in 2000L single-use bioreactors. Initially, four 2000L bioreactors have been installed. The modules were pre-built in Germany then transported to China for assembly in 8 days. The facility was operational within 18 months.

The JHL Wuhan facility design was optimized to provide efficient use of space and process flow and utilize the FlexFactory a single-use manufacturing platform so it would complement their plant in Taiwan. The standardized nature of the FlexFactory-fitted KUBio will facilitate easy scale-up from process development and early clinical manufacturing in Taiwan, to late-stage clinical manufacturing and commercial production at the new site in Wuhan. Parallel production of the KUBio modules and the FlexFactory processing equipment, during site preparations enabled JHL to reduce the overall timeline and begin production as soon as possible.”

Finalists

FUJIFILM DioSynth – Re-Purposing a Microbial Facility for Multi-Product GMP Manufacturing

Gibraltar Laboratories – CGMP Independent Lab and Sterilization Services

 

Congratulations to all the winners and finalists!

For full descriptions of the awards and winners, please see – 2016 BioProcess International Award Winners

For more Boston Biotech Week Coverage, please see:

 

Don’t miss BioProcess International West – BPI West in San Francisco February 27- March 2, 2017