Lonza, a global leader in biological development and manufacturing, announced today the release of its second-generation immunogenicity assessment platform. The upgraded platform consists of state-of-the-art in silico and in vitro/ex vivo technologies to evaluate immunogenicity risk during the pre-clinical development of therapeutic proteins. In the context of vaccine and cell therapy development, the platform enables the rational design and testing of optimal immune responses in healthy donor or patient populations. This second-generation platform provides a comprehensive toolbox to assess customers’…
Author Archives: BPI Contributor
S-Bio Launches EZGlyco mAB Kit with 2-AB for N Glycan Sample Preparation from IgG in cell culture for HPLC analysis
S-BIO1 has launched today EZGlycoâ„¢ mAb-N Kit with 2-AB, a breakthrough new product that enables scientists to analyze N -glycans in IgG and Fc-fusion proteins from culture supernatant samples in a rapid, simplified and streamlined single tube operation. The kit is a valuable tool supporting customers in glycoprotein characterization for biotherapeutic development. Therapeutic monoclonal antibodies (IgG, mAb) are routinely expressed in recombinant expression systems. N-glycosylation is one of the most important post-translational modifications. Monitoring of glycosylation in antibody development and…
Getting Big Benefits from Small Components
Like a chain, a biopharma transfer system depends on each of its links being strong enough to protect the integrity of the materials being transferred. In order to prevent problems associated with contamination, the system must be able to maintain a pure environment. Container closures and stopper systems are sometimes seen as small items, but choosing the right components is vital. The impact of specifying the appropriate closure or stopper system can be felt throughout an entire fluid transfer process.…
Sartorius Stedim Biotech Presents the First Fully Integrated Upstream Platform
Sartorius Stedim Biotech (SSB), an international leading supplier for the biopharmaceutical industry, has developed an innovative and fully integrated technology platform to meet the requirements of today’s upstream bioprocessing. It combines a top-performing expression system with outstanding equipment and process control for the rapid development and scale-up of robust, high-titer commercial manufacturing processes. The biopharmaceutical industry is facing a series of challenges that it must address in order for it to deliver safe and efficacious products to a market made…
How to Boost Profits with Single-Use Powder Transfer
This webcast features: Chris Rombach, Director of Global Strategic Accounts, ILC Dover Biopharmaceutical manufacturers face a number of challenges. Open-suite biopharma manufacturing is gaining popularity. But it also leaves surfaces open to contamination, workers at risk for exposure to airborne particulates, and processes more exposed to product loss due to waste or spillage. Liquid handling systems adapted for dry powder applications are often a compromise, because liquid and powder flow rates, handling characteristics and dispensing volumes differ dramatically. A purpose-built,…
Silicone Suction Hose from AdvantaPure is Now NSF Listed
AdvantaPure now offers its high purity silicone suction hose with a National Sanitation Foundation listing (NSF-51). Applications for the hose include ultrapure water transfer, food processing, beverage conveyance, washdown stations, skid systems, and other suction and discharge uses in the food, dairy, beverage, pharmaceutical, biopharmaceutical, chemical and cosmetics industries. Called APSW, the hose begins with a liner of low volatile grade, platinum-cured silicone. The liner is slipped onto a mandrel and wrapped with four plies of polyester mesh fabric, 316…
Principles and Troubleshooting of Large Scale Column Packing
This webcast features: J. Kevin O’Donnell, PhD, Process Chromatography Support Manager, Tosoh Bioscience This presentation focuses on the packing of process scale chromatography columns. Including general principles of column packing, common packing techniques used in packing process scale columns, qualification and evaluation of the packed column, and the troubleshooting of issues common to large scale column packing.
Accessory Closure Lids Provide Maximum Flexibility for 3D Biocontainer Deployment
Meissner’s QuaDrum® rigid outer container portfolio is now available with three closure lid options. The QuaDrum® container’s closure lids allow varying degrees of access for your process when deploying 3D biocontainers with nominal process volumes from 50 L to 200 L. The three closure lid options include a standard lid, an access lid and a retaining lid. The standard accessory lid provides full biocontainer coverage and delivers maximum security when storing process fluids. The access lid allows interaction with fluid…
Tosoh Bioscience Introduces TSKgel® Protein A-5PW HPLC Columns
Tosoh Bioscience LLC, a provider of chromatographic solutions for the separation of biomolecules, today announced the introduction of the TSKgel Protein A-5PW column. This column is specifically designed for the rapid separation and robust monoclonal antibody titer quantification during cell line selection or upstream bioprocess optimization and control.  The TSKgel Protein A-5PW column is now available for sale in the Americas from Tosoh Bioscience LLC. The TSKgel Protein A-5PW column is packed with 20 μm hydroxylated methacrylic polymer beads coupled…
MilliporeSigma to Provide Provantage® End-to-End Development and Manufacturing Services to Y-mAbs for Lead Antibody Compound
MilliporeSigma will provide its Provantage® End-to-End development and manufacturing services to Y-mAbs Therapeutics, Inc. in support of Y-mAbs’ monoclonal antibody in late stage clinical development. The antibody, targeting refractory leptomeningeal tumor neuroblastoma and diffuse intrinsic pontine glioma, is a potential breakthrough treatment for pediatric patients. Following transfer of Y-mAbs’ lead cell line to MilliporeSigma, services will include scale-up and GMP manufacturing of an antibody currently in late stage clinical development. “Pediatric brain cancer is an especially challenging therapeutic area that comes with…