with Dr. Andreas Anton and Dr. Sebastian Schuck Poorly soluble substances form aggregated inclusion bodies (IBs) in microbial cells containing incorrectly and/or incompletely folded target proteins. Wacker Biotech, a full-service contract manufacturer of biopharmaceuticals based on microbial systems, has introduced FOLDTEC refolding technology for bioengineered therapeutic proteins. The proprietary platform uses specifically developed and optimized bacterial strains and a patented, antibiotic-free expression system. In a BPI webinar on 9 November 2015, Wacker’s director of bioprocess development (Andreas Anton) and head…
Author Archives: BPI Staff
Nominations Open for the 2016 BioProcess International Awards – Recognizing Excellence in BioProcessing
BioProcess International (BPI), the biopharmaceutical industry´s leading business to business publication announced the opening of nominations for the 2016 BioProcess International Awards – Recognizing Excellence in BioProcessing. The 2016 BPI Awards recognizes and honors the individuals, organizations, and technologies that most significantly impacted and advanced biotherapeutic development and manufacturing. The 2016 BPI Awards are grouped into three main categories: People, Organizations, and Technologies. The People category will recognize Best Collaboration and Excellence in Leadership in the bioprocessing industry. The Organizations…
Spotlight
New Sandoz Biosimilar Drug-Product Facility In September 2015, Sandoz (the generics and biosimilars business of Swiss drug maker Novartis) opened its BioInject biomanufacturing facility in Schaftenau, Austria. Over €150 million of investment is creating 100 highly skilled jobs in a state-of-the-art facility for manufacturing prefilled syringes and devices for both biosimilars and novel biologics. Staff can fill 18,000 syringes/hour and package 100 syringes/minute. In welcoming guests at the opening, Carol Lynch (global head of biopharmaceuticals and oncology injectables at Sandoz)…
Spotlight
Niche Disease: Epidermolysis Bullosa by Cheryl Scott Epidermolysis bullosa (EB) is a group of rare diseases that cause skin to blister easily. In severe cases, blisters may even be internal (e.g., in mucosal tissues or organs). More than 300 mutations have been identified in this condition. Most of the many types of EB are inherited, and the condition usually manifests in infants and young children; some patients don’t develop symptoms until adolescence or early adulthood. Exceptionally mild cases may remain…
Ask the Expert: Taking Medium and Feed Development Beyond Maximizing Protein Titer to Optimizing Glycan Distribution and Simplifying Process Scale-Up
with Serena Fries Smith (Thermo Fisher Scientific) In the early 2000s, maximizing expression titers was the industry’s biggest challenge. Over the past 10–15 years, significant advances in media and feeds have enabled standard fed-batch processes to achieve 3 g/L, some as high as 7 g/L. The productivity increase is enabling scientists to move beyond titer and focus resources on addressing other scientific challenges (e.g., product quality modulation and process scale-up). One way to address those challenges is by leveraging feed…
JSR Life Sciences to present data on Next Generation Protein A Chromatography Resin at BPI 2015
JSR Life Sciences announced today that it will release Amsphereâ„¢ A3, a next generation Protein A chromatography resin for advanced protein separation in downstream processing of therapeutic antibodies manufacturing at the IBC Life Sciences’ BioProcess International Conference & Exposition in Boston, MA held Oct. 26-29, 2015. Amsphere A3 will be commercially available in January 2016. Amsphere A3 is a high capacity resin with overall improved process robustness, flow characteristics, optimized impurity removal, productivity and resin lifetime. JSR launched its first…
Vetter Opens Office in Japan to Serve Growing Asian Healthcare Market
Vetter, one of the global leaders in the aseptic manufacturing of drug-delivery systems, servicing the top-ten pharma/biotech companies worldwide along with mid-size companies and emerging startups, today announced the opening of a new business entity in Tokyo, Japan. The announcement was made at a ceremony attended by executives of customer and partner companies with a presence in the Asian region, as well as Vetter and industry executives. Mr. Hiroaki Suzuki in his role as Business Development Manager for Vetter Pharma…
Ask the Expert: Simulation and Optimization Software for Continuous Chromatography
with Thomas Flouquet (Novasep) The first simulation and optimization software for chromatography process development in biopharmaceutical purification, the BioSC Predict program from Novasep received an 2015 Achema award for Pharmaceutical Engineering. Driven by user objectives, it can define practical constraints and desired strategies. Optimization algorithms provide the most adapted operational conditions for a BioSC system. In a webcast on 17 September 2015, Novasep’s Thomas Flouquet demonstrated the software’s functionality and customizability. He presented optimized recipes taking into account parameters such…
Ask the Expert: Cell Culture Media Supplementation
with Dr. James Brooks (BD Biosciences) Improvements in cell culture media and supplementation have enabled significant advancements in bioproduction titers. But optimization to meet the specific needs of individual production cell lines is key to achieving desired production and protein quality, especially for biosimilars. Not only is it desirable to achieve cost-effective levels of production, but quality characteristics also are essential — and for biosimilars must closely resemble those of the originator molecules. Fully chemically defined (CD) media formulations are…
September 2015 Spotlight
Sartorius Opens New Applications Center In June 2015, Sartorius opened an application center at its North American headquarters in Bohemia, NY. Among the guests were representatives from local government, customers and business partners, and industry media including BPI’s publisher, Brian Caine. The New York Sartorius Application Center provides customers with access to multiple single-use systems for upstream and downstream processing. Demonstration laboratories present equipment by application and to show how individual systems work together for complete process solutions. This 40,000-ft2…