Sartorius Stedim Biotech (SSB), a leading international supplier for the biopharmaceutical industry, announced the launch of its next generation BIOSTAT STRĀ®, a fully scalable, single-use bioreactor family based on a conventional stirred-tank design. This new bioreactor range featuring upgraded hardware and software, as well as a fully integrated, new design of Flexsafe STRĀ® single-use bags, ensures quick and easy bioprocess scale-up of biologics and vaccines. The BIOSTAT STRĀ® bioreactors are equipped with an improved stainless steel bag holder for user…
Author Archives: BPI Contributor
Charter Medical Announces Exclusive Global Distribution Agreement with INCELL Corporation
Charter Medical Ltd., a Fenner PLC subsidiary (LSE:FENR), a globally recognized manufacturer of products for the regenerative medicine and bioprocessing industries, announced today that it has established a strategic partnership with INCELL Corporation, an innovative developer and manufacturer of specialty medias and formulated solutions for tissue and cell collection, transport, processing and storage. The partnership will enable both organizations to meet the growing customer demand for more comprehensive solutions in cell culture, cell expansion, and cryopreservation. Mary Pat Moyer, Founder,…
Sartorius Stedim Biotech Launches Chemistry Testing Services
Sartorius Stedim Biotech (SSB) announced the launch of a full range of chemistry testing services. Offered by its subsidiary Sartorius Stedim BioOutsource, they characterize the physicochemical properties and structural attributes of therapeutic monoclonal antibodies (MAbs). The service platform methods have been developed to ensure rapid sample analysis and reporting for MAbs and biosimilars. This comprehensive range of chemistry testing services complies with the well-established ICH Q6B scientific guidelines for pharmaceuticals for human use, and includes methods to characterize protein structure,…
Solving Problems in the Production of Complex Proteins and Other Biologics
This webcast features: James Brady, PhD, VP of Technical Applications and Customer Support, MaxCyte, Inc. Moving bispecific and complex protein therapeutics from the bench to the clinic requires a scalable process that is consistent and reproducible while delivering a biologically active product. MaxCyteās delivery platform is a high performance, electroporation-based technology that can rapidly generate milligram to gram quantities of protein in the cell line of choice. You will learn: How to express quality bi-specific antibodies, bi-specific T cell engaging…
MilliporeSigma Collaborates with LabCentral to Foster Biotech Startups
MilliporeSigma announced today that the company will sponsor the Startup Program at LabCentral, a biotechnology incubator, in Cambridge, Massachusetts. LabCentral is a private, non-profit organization that provides entrepreneurs and innovative life-sciences startups with lab space and resources to nurture the next generation of biotech companies. It comprises approximately 125 scientists and entrepreneurs. MilliporeSigma’s collaboration with LabCentral, like its ongoing Emerging Biotech grant program, gives biotech startups access to process development tools, education programs and training to support their success and…
Celeros Separations LLC Releases New Line of Automatic Piston Discharge Centrifuges for Bioprocessing Industry
Formerly known as Celeros, Inc in Foxborough, MA, Celeros Separations LLC has been acquired by its founder Robert Bret Carr and is now under new ownership and management based in Durham, NC. This change of ownership is effective as of January, 2017. The Celeros family of APD centrifuges, which includes the APD-75, APD-125, APD-250 and APD 125 II, are semicontinuous automatic solids-discharge high-speed tubular bowl centrifuge. The core technology is the unification of three unique features in one package: the…
MilliporeSigma Releases Poloxamer 188 EMPROVEĀ® EXPERT Polymer for Cell Culture Media
The Poloxamer 188 EMPROVEĀ® EXPERT polymer is a surface-active nonionic polymer used in cell culture media as a shear protectant and has become a standard component to cell culture media for production processes. The new polymer increases robustness of mammalian cells to shear from sparging, resulting in increased viability of cells in the bioreactor. For biopharmaceutical manufacturers, MilliporeSigmaās Poloxamer 188 EMPROVEĀ® EXPERT polymer helps to ensure lot-to-lot consistency and reliable performance. The product has been cell culture tested, optimized and…
Accelerating Biosimilar Development Programs using Contract Testing and Manufacturing Organizations
A rapid increase in the number of companies working on the development and registration of biosimilars and the need to get these products to market with speed has lead biosimilar developers to turn to contract research organizations (CROs) when they lack either the internal capability or capacity for conducting certain work. Throughout the biosimilar development pathway, a product sponsor can choose to conduct the work itself or use service contractors. Contractors can be niche providers of a single aspect of…
Contract Test Services from Associates of Cape Cod, Inc.: Specializing in Testing for Endotoxin and Glucan Contamination
Associates of Cape Cod,Ā® Inc. Contract Test Service (CTS) laboratory specializes in testing for endotoxin and glucan contamination and has notable experience in endotoxin testing. CTS performs all methods of the BET assay: gel-clot, chromogenic, and turbidimetric. CTS is GMP compliant and ISO registered. Weāre licensed by the DEA as a laboratory capable of handling all controlled drug substances except those included in Schedule I. Endotoxin testing can be performed in accordance with FDA, USP, EP and/or JP, depending on…
Platform Purification of Six Biosimilar Molecules Using Amsphere A3 ā Protein A Resin
Currently more than 70 biosimilar mAbs (monoclonal antibodies) are under development and multiple originator mAbs are going off-patent in the next 3-4 years. Protein A resin remains the most important workhorse for the purification of monoclonal antibodies. Protein A resin has a high impact on both development and manufacturing cost, in particular during early stage clinical phases. This application note summarizes the key performance parameters for our high capacity protein A resin, Amsphere A3, for 6 biosimilar molecules of which…