DOWNSTREAM PROCESSING FEATURED ARTICLES
Combination Sterile Connections For Single-Use Applications
Gain insight into why combination connections are used in single-use bioprocessing and guidance on how single-use systems can be designed to integrate the combination connectors.
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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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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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Investigational Brain Cancer Vaccine To Be Tested In Phase I Roswell Park Study
A new clinical research study at Roswell Park Cancer Institute(RPCI) will test a first-of-its-kind cancer “vaccine” that may prove effective against many forms of solid-tumor cancers.
DOWNSTREAM PROCESSING WHITE PAPERS & CASE STUDIES
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Mammalian Virus Purification Using Ceramic Hydroxyapatite
Conventional techniques for mammalian virus purification produce variable quality, quantity, and significant loss of particle infectivity. We propose the chromatographic separation of viral particles of diverse sizes and from different families such as dengue, influenza, mouse hepatitis, adenovirus, poliovirus using CHT Ceramic Hydroxyapatite resin.
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Connection Technology Advances Closed System Processing
The global demand for new biologics and vaccines, combined with the growing emergence of biosimiliars, is challenging drugmakers to re-evaluate their processes and seek ways to make them more flexible, reliable, and cost-effective. By John Boehm, Colder Products Company
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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).
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The Challenge of Measuring Total Organic Carbon In Modern Pharmaceutical Water Systems
Total Organic Carbon (TOC) is one of the quality attributes defined in the European and USA pharmacopoeias for pharmaceutical waters. Modern water treatment systems can deliver such high purity water that TOC levels can be consistently close to zero and very difficult to measure with any accuracy. This paper discusses some of the challenges when using TOC analysers to demonstrate pharmacopoeial TOC level compliance for modern water systems in the light of the ICH Q2 document from the International Conference on Harmonisation.
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Chromatography Column Protection With 3M Purification LifeASSURE™ PLA Series Membrane Filters Protective, or guard, filters are often used in chromatography column purification steps to protect the column media from contaminants in the various fluids that come in contact with the column.
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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.