DOWNSTREAM PROCESSING FEATURED ARTICLES
Roche announced recently that the European Commission (EC) has approved Avastin (bevacizumab) in combination with standard chemotherapy (carboplatin and gemcitabine) as a treatment for women with first recurrence of platinum-sensitive ovarian cancer.
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Skystar's New Vaccine Facility In Huxian Passes Initial GMP Certification
Skystar Bio-Pharmaceutical Company (NASDAQ: SKBI) ("Skystar" or the "Company"), a China-based manufacturer and distributor of veterinary medicines, vaccines, micro-organisms and feed additives, today announced that China's Ministry of Agriculture (MOA) Good Manufacturing Process "GMP" experts have certified that Skystar's new vaccine facility in Huxian, China is 'Stage 1' GMP compliant.
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Lonza And OncoMed Pharmaceuticals Sign A Process Development And Manufacturing Collaboration And Multi-Product GS License Agreement For Anti-Cancer Therapeutics
Lonza, a global leader in biological manufacturing and OncoMed Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company dedicated to improving cancer treatment, announced recently an agreement for the development and manufacture of OncoMed’s pipeline of anti-cancer stem cell therapeutics.
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Standardized Extractables Testing Advances Single Use Adoption
The Standardized Extractables Testing Protocol For Single-Use Systems In Biomanufacturing written by BPOG members last year establishes a foundation from which to create a standardized approach to extractables testing. However, since its release, there have been some questions and discussions about how to effectively implement the protocol.
DOWNSTREAM PROCESSING WHITE PAPERS & CASE STUDIES
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Turning Data Into Information
As biopharmaceutical manufacturing has evolved from small-scale lab production in small flasks to massive commercial production in deep-tank bioreactors, an avalanche of production data has evolved to support it. From individual unit operation skids to distributed control systems and enterprise resource planning tools, biomanufacturing today is buried by the sheer quantity of data coming in from the manufacturing floor.
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Rapid Screening Of A Cell-Based Assay For GLP-1 Receptor Using A Natural Product Library
Here we demonstrate the detection of GLP-1R binding through the incorporation of a homogeneous cell-based binding assay using HTRF Tag-lite® technology. By Brad Larson and Peter Banks, BioTek Instruments, Inc. and Nicolas Pierre, Suzanne Graham, Jean-Luc Tardieu, and François Degorce, Cisbio US, Inc.
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Selecting The Optimal Resins For The Process Purification Of Native And Recombinant Proteins
Native and recombinant proteins are used in a variety of applications ranging from drug discovery to target validation to high-throughput screening. Due to this, large-scale protein production and purification have become major necessities in industrial settings.
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White Paper: 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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Rapid Chemically-Defined Feed Media Development to Improve Simulated Cell Culture Processes
Implementing an optimized feed medium may be the most effective alternative for modifications to the growth medium in an existing process.
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Biological Contamination Events In Isolators: What Lessons Can Be Learned?
Microbiological deviation and biological contamination events have been observed in pharmaceutical isolators including those used in production, sterility test and pharmacy aseptic services. By James Drinkwater, Bioquell UK Process & Compliance Director