DOWNSTREAM PROCESSING FEATURED ARTICLES
Sanofi Pasteur, the vaccines division of Sanofi, announced recently the online publication in The Lancet of clinical study results showing the ability of its vaccine candidate to protect against dengue fever caused by three dengue virus types. The results of the world’s first efficacy study confirm the excellent safety profile of Sanofi Pasteur’s dengue vaccine candidate.
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Novavax Initiates Phase 2 Clinical Trial Of RSV Vaccine Candidate
Novavax, Inc. today announced that enrollment has begun in a Phase 2 dose-ranging clinical trial of its respiratory syncytial virus (RSV) vaccine candidate in women of childbearing age.
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Galapagos And Roche Conclude Strategic Alliance
Galapagos NV (EURONEXT BRUSSELS: GLPG) announced today that it agreed with Roche to end their alliance in fibrosis.
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FDA Approves First Seasonal Influenza Vaccine Manufactured Using Cell Culture Technology
The U.S. Food and Drug Administration announced recently the approval of Flucelvax, the first seasonal influenza vaccine licensed in the United States produced using cultured animal cells, instead of fertilized chicken eggs. Flucelvax is approved to prevent seasonal influenza in people ages 18 years and older.
DOWNSTREAM PROCESSING WHITE PAPERS & CASE STUDIES
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Important Considerations For Implementing A Single-Use Biomanufacturing Strategy
Recent trends in biomanufacturing technology and the biopharmaceutical market are supporting the increased adoption of single-use (SU) manufacturing systems. On the demand-side, the biopharma industry is focusing on niche and rare diseases with smaller patient populations, resulting in the need for smaller, more agile biomanufacturing capacity. By Jodi M. Zobrist and Nicole W. O'Brien, Ph. D., Gallus Biopharmaceuticals, LLC
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SciLog - Creating Advanced Biotech Equipment With Mettler Toledo For nearly two decades, SciLog, Inc. has been dedicated to creating revolutionary single-use purification systems and disposable sensor technologies.
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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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Avoiding Drug Shortages With Microbial Detection
Over the past year, critical drug shortages used to treat a host of life-threatening illnesses have been making headlines. Microbial contamination has been cited as a major contributor to the shortage, yet the prevailing practices to ensure the safety of drugs have been slow to change. In most cases, quality assurance practices safeguarding the drug making environment continue to rely on periodic air and a culturing method from a prior century. By Aric Meares, President and CEO, BioVigilant
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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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Sani-Tech® Ultra White Paper
For several years, pharmaceutical manufacturing professionals have increasingly stated concerns about material leachables and extractables and their impact on the products they produce. Fluid transfer systems that include flexible tubing have been at the forefront of this discussion.