DOWNSTREAM PROCESSING FEATURED ARTICLES
Selexys Pharmaceuticals, Corp., announced today that it has successfully completed a $23 million Series A equity financing, led by MPM Capital. Additionally, Selexys entered into an agreement with Novartis Pharmaceuticals whereby Novartis has been granted an exclusive option to acquire Selexys and its lead asset, the anti-P-selectin antibody SelG1, following the successful completion of a Phase 2 clinical study in patients with sickle cell disease.
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![PhenomemexTabless-Tube-Hold]( "New SPE Accessories Hold Tubes In 96-Well Spacing For Automated Applications")
New SPE Accessories Hold Tubes In 96-Well Spacing For Automated ApplicationsPhenomenex Inc., a global leader in the research and manufacture of advanced technologies for the separation sciences, introduces two new Tabless Tube Holder accessories for its Strata and Strata-X lines of silica-based and polymeric solid phase extraction (SPE) sorbents.
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Successful Immunization And Safety Documented In Nasal Administration Study Of The HIV Vaccine Vacc-4x Together With Endocine
Bionor Pharma ASA (
OSLO :BIONOR), Eurocine Vaccines AB and Oslo University Hospital today announced that vaccine related immune responses are documented in patients given active vaccine in a nasal immunization study, combining Bionor Pharma's Vacc-4x and Eurocine Vaccines' adjuvant Endocine. -
Genetic Immunity Receives GMP Certification For In-House Manufacturing Facility
Genetic Immunity (OTCBB: PWRV) is pleased to announce the GMP approval of its manufacturing facility. The development of the GMP manufacturing process and the facility was financed from a $4 million grant received from the Hungarian Office for Innovation and Technology.
DOWNSTREAM PROCESSING WHITE PAPERS & CASE STUDIES
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![450x300 drug model-inside protein molecule]( "Important Parameters For Packing Nuvia HR-S Resin At Process Scale")
Important Parameters For Packing Nuvia HR-S Resin At Process ScaleProcess-scale production typically involves more than one column. The packing quality of each column affects the efficiency of the whole workflow and is an important validation criterion.
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Quality By Design In Biomanufacturing
QbD is increasingly required in our industry, but there are still gaps in understanding how QbD applies to the biomanufacturing process.
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Managing Cell-Based Potency Assays: From Development To Lifecycle Maintenance
Characterization of a biological product — which includes the determination of physicochemical properties, biological activity, immunochemical properties, purity and impurities — is necessary to establish the safety and efficacy profile of a given product (ICH Q6B). By Dr. Weihong Wang, manager, Molecular and Cell Biology, Eurofins Lancaster Laboratories
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![Bulletin_5825Photo.jpg]( "Best Practices For Process Scale Column Packing Of CHT™ Ceramic Hydroxyapatite Media")
Best Practices For Process Scale Column Packing Of CHT™ Ceramic Hydroxyapatite MediaCHT ceramic hydroxyapatite media require specific considerations during process-scale chromatography packing due to high specific gravity, rapid settling rate, and sensitivity to mechanical shear.
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Economic Analysis Of Single-Use Tangential Flow Filtration For Biopharmaceutical Applications Prior to creating an accurate economic model for TFF, a thorough understanding of the process where the TFF is used is needed. A process model is a valuable tool when properly executed and it must accurately include all critical aspects of the purification process. By Michael LaBreck, Mark Perreault, Novasep
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Efficiency Test Of ReadyToProcess™ Columns
ReadyToProcess™ columns are prepacked, prequalified, and presanitized process chromatography columns suited for purification of biopharmaceuticals (e.g., proteins, vaccines, plasmids, and viruses) for clinical phase I and II studies. ReadyToProcess columns are available with several media at different volumes (1, 2.5, 10, and 20 L).
DOWNSTREAM PROCESSING PRODUCTS
Magnosphere™ is a superparamagnetic particle for in vitro diagnostics and bio research applications.
AseptiQuik® STC Connectors integrate the AseptiQuik® sterile connector and the Steam-Thru® II SIP connector, giving manufacturers even greater flexibility for hybrid stainless steel and single-use processing.
The DoverPac® Bag In/Bag Out (BIBO) containment system is a family of contained transfer designs for multiple processes. The primary components for this validated operation consist of multiple groove canisters, docking interface hardware, and softgoods in either continuous liner form or discreet liners.
ÄKTA avant™ is a preparative chromatography system designed for fast and secure development of scalable methods and processes.
DOWNSTREAM PROCESSING MULTIMEDIA
Bioprocess With The Bozenhardts is back, with a fresh episode packed with advice from Herman and Erich on the selection of filling systems for biopharmas. Listen in as the Bozenhardts give us an update on the process, logistics, and administration trends that are informing filling system decisions today, and offer direction on making choices that will prepare you for the fast-advancing therapies of tomorrow.
Bio-Rad now offers two very high capacity ion exchangers: Nuvia S, which can be used for capture and/or intermediate polishing; and Nuvia Q, which can be used for intermediate and/or final polishing.