DOWNSTREAM PROCESSING FEATURED ARTICLES
Repligen Corporation announced recently that it has acquired the business of Refine Technology (“Refine”), including Refine’s Alternating Tangential Flow (“ATF”) System, a market-leading device used to significantly increase product yield during the fermentation step of the biologic drug manufacturing process.
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NIH-Supported Study Shows How Immune Cells Change Wiring Of The Developing Mouse Brain
Researchers have shown in mice how immune cells in the brain target and remove unused connections between brain cells during normal development.
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Novartis To Start Construction Of New Biotechnology Facility In Singapore With An Investment Of Over USD 500 Million
Novartis announced recently the construction of a new state-of-the-art biotechnology production site in Singapore with an investment valued at over USD 500 million. The new facility will focus on drug substance manufacturing based on cell culture technology.
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First Patient Treated In Genelux Phase I Trial With GL-ONC1 At Memorial Sloan Kettering Cancer Center
Genelux Corporation, a clinical-stage biopharmaceutical company developing vaccinia virus-based cancer therapies and companion diagnostics, today announced that researchers at Memorial Sloan Kettering Cancer Center (MSKCC) in New York treated the first patient in a Phase I clinical trial of GL-ONC1 in people with malignant pleural effusion, a complication that occurs in about 30 percent of lung cancers.
DOWNSTREAM PROCESSING WHITE PAPERS & CASE STUDIES
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Single-Use Connections Advance Aseptic Processing
John Boehm discusses how single-use connections advance aseptic processing and create increased process flexibility and reliability while reducing costs.
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Comparability Of The Cell-Freeze® (Charter Medical) Freezing Bag To The Cryocyte™ (Baxter) Bag For Cryogenic Storage Of Human Hematopoietic Progenitor Cells Successful cryopreservation of hematopoietic progenitor cells (HPC) is dependent upon a number of factors, including the biopreservation media, freezing rates, and storage using sterile, cryogenically durable storage bags. The Cell-Freeze® cryogenic storage containers are 510(k) cleared for storage, preservation and transfer of hematopoietic progenitor stem cells (HPC’s). By Charter Medical, Ltd.
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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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Effect Of Sterilization On Mechanical Properties Of Silicone Rubbers
Silicone rubber is widely used in the pharmaceutical industry where sterilizability is an essential requirement for all fluid transfer equipment. Pharmaceutical products must be sterilized frequently and repeatedly by high level energy and/or chemical vapor in order to eliminate bacterial surface contamination.
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White Paper: 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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Optimized Sterile Filtration of Pharmaceutical Solutions
The cost of filtration and separation stages within the production of pharmaceuticals has been increasing along with the increased complexity of final drug products.