2016 BioProcess International Award Winners – Upstream and Analytical
At this year’s Boston Biotech Week, novel technologies in upstream, downstream and analytical application areas received a 2016 BioProcess International Award. I have listed the winners and finalists along with a brief description of the winning achievements for upstream and analytical technologies here. These awards recognize outstanding achievements in the area of biotherapeutic development and manufacturing processes. For a list of downstream technology and facility winners, please see 2016 BioProcess International Award Winners – Downstream and Facilities.
Category – Best Technology Application – Upstream
Winner: Ranger Service – Stratophase
“Ranger™ is an innovation in cell culture upstream process development that, for the first time, permits changes in the metabolic rate of cell cultures to be measured in real-time and on-line. This information then allows for process parameter changes to keep the cells in an optimally active and healthy condition. Use of this innovative new approach in cell culture process development has resulted in multiple benefits: more robust processes developed, shorter timelines and improved productivity. This new approach provides insights into the dynamics of the cell culture process that were not previously available.”
Finalists
BioProfile Flex 2 Comprehensive Modular Cell Culture Analyzer – Nova Biomedical
“BioProfile is a chemistry/cell viability modular instrument that measures up to 15 key cell culture attributes. By combining as many as five separate instruments into one easy-to-use instrument, BioProfile FLEX simplifies workflow and saves time, labor, and operating cost versus multiple instruments. FLEX2 was developed for all areas of cell culture. High throughput design with analysis times as fast as two minutes per sample, coupled with extremely low sample volume requirements provides solutions for high throughput screening studies and enables sampling of small volume culture systems.”
Sedimentation in an Automated Microbioreactor (SAM) – Glycotope
“The SAM model is ideal for selecting clones that will produce product with the desired product quality characteristics. Product produced in the SAM model has highly comparable glycosylation patterns and other product quality attributes to that from the 1 L-scale. Furthermore, Glycotope have shown consistent glycosylation profiles between the 12 mL and 1000 L scales. Glycotope have demonstrated that the SAM model is ideally suited for optimizing cell cultures using a DoE methodology. In one experiment they performed, they ran 18 perfusion cultures in parallel using the ambr®15 systems and were able to identify optimum operating conditions. To perform the equivalent experiment at the 1L –scale would have been costly, time consuming and labour-intensive.”
Category – Best Technology Application – Analytical
Winner: High Throughput Glycosylation Analysis – Sciex
“There is a growing demand in the biopharmaceutical industry for high throughput and, large scale N-glycosylation profiling of therapeutic antibodies in all phases of product development, but especially during clone selection where hundreds of samples should be analyzed in a short period of time to assure their glycosylation based biological activity. Therefore development of a novel fully automatable protocol was necessary and the magnetic bead based protocol for N-glycosylation analysis of glycoproteins alleviated the hard-to-automate centrifugation and vacuum-centrifugation steps of the currently used protocols.”
Finalists
To enable a more automated and PAT (Process Analytical Technology) friendly approach to cell culture monitoring, Ovizio developed an innovative microscopy technology, the iLine F, that instead of taking a 2D image of a microscopic object, takes a hologram of a microscopic volume. Then for each microscopic object within the volume, it can compute a holographic fingerprint. This fingerprint. based on 59 parameters, can then be used to identify the cell type, whether it is alive or dead and other key parameters. Ovizio likens this holographic fingerprinting cell identification that uses machine learning to the mobile app Shazam’sTM ability to identify a song by just hearing a few seconds of it.
The iLine F employs differential digital holographic microscopy, a quantitative imaging technique that allows cell counting as well as cell viability monitoring in a continuous label free approach. This allows the iLine F to monitor cell growth inside the bioreactor on a single cell level, which permits tracking of cells, how they are performing against established parameters and to continuously document the process and thus enabling PAT implementation. To learn more about the iLineF, please see “Cool Tool – Smart Cell Culture Monitoring, Transform single cell parameters into cell culture intelligence.”
BioLayer Interferometry (Octet) – Catalent Pharma Solutions
“The system defined is, essentially, a toolbox approach for assessing mAb/Fc receptor binding kinetics. The intent is to eventually use the analytical panel both for characterization of biosimilar molecules and comparison to originator molecules, as well as for CMC-related release and stability testing.”
Category – Excellence in Leadership
Winner: Igor Fisch, PhD, CEO, Selexis
Finalists:
Marcel Bassil, Associate Director, Benta SAL
Olivier Loeillot, General Manager, Genomics & Cellular Research, GE Healthcare
Category – Emerging Company
Winner: NuMedii
“NuMedii, Inc., discovers effective new drugs by translating its predictive data intelligence technology into therapies with a higher probability of therapeutic success. The Company’s exclusive Big Data technology, originally developed at Stanford University, utilizes large amounts of scientific data together with proprietary biological network-based algorithms to discover drug-disease connections and biomarkers that are predictive of efficacy. NuMedii translates these predictions into novel de-risked drug candidates and partners with pharmaceutical companies for development and commercialization. The Company’s proprietary and dynamic Big Data technology, consists of hundreds of millions of raw human, biological, pharmacological and clinical data points that the company has normalized and annotated. The company integrates these data with proprietary network-based algorithms to find both drug candidates and biomarkers predictive of efficacy for diseases.”
Finalists
Quad Technologies
“Founded in 2013 to explore the potential of a unique dissolvable hydrogel technology invented at Northeastern University, Quad Technologies is disrupting cell separation and Cell Therapy workflows by providing cell biologists with a simple, cell-friendly capture and release technology for cell isolation. The company’s primary focus is on developing best-in-class cell separation reagents for immuno-oncology and translational medicine applications. Quad Technologies’ MagCloudz™ Cell Separation products use magnetic particles as a carrier for their proprietary QuickGel™ technology, which enables target cell capture via a familiar magnetic cell isolation workflow. At the end of the cell separation process, using the Q-Mag or comparable magnetic stand, the MagCloudz™ are dissolved in less than one minute, using a biologically friendly buffer. This releases the target cells from the magnetic carriers, leaving the captured cells behind in their native state after removal of the magnetic particles. Quad Technologies’ unique cell release capabilities drastically increase cell viability compared to conventional magnetic separation products and eliminate retained magnetic labels from isolated cell populations.”
Cell and Gene Therapy Catapult
“The Cell and Gene Therapy Catapult vision is for the UK to be a global leader in the development, delivery and commercialisation of cell and Gene Therapy. Where businesses can start, grow and confidently develop cell and gene therapies, delivering them to patients rapidly, efficiently and effectively. Our mission is to grow the industry in the UK to substantial and sustainable levels by: taking products into clinical trial, de-risking them for further investment; providing clinical expertise and access to NHS clinical partners; providing technical expertise and infrastructure to ensure products can be made to GMP and delivered cost effectively; providing regulatory expertise to ensure that products can get to the clinic safely, in the shortest amount of time; providing opportunities for collaboration, both nationally and globally; and providing access to business expertise, grants and investment finance so that commercially viable products are progressed and investable propositions are generated.”
Category – Corporate Leadership
Winner: GlaxoSmithKline – The PULSE Partnership Program
Finalists
Biogen – Closing the Hemophilia Gap in the Developing World
Baxter – The Baxter International Foundation
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:
“Boston Biotech Week 2016 – Downstream Coverage – In case you missed it!”
“2016 BioProcess International Award Winners – Downstream and Facilities”