DOWNSTREAM PROCESSING FEATURED ARTICLES
Morphotek®, Inc., a subsidiary of Eisai Inc., announced today that The American Association of Pharmaceutical Scientists (AAPS) has awarded its 2012 Excellence in Ligand Binding Assays Award to the Bioanalytical Development group from Morphotek for their abstract, “Development and Validation of a Pharmacokinetic Assay on the Gyrolab Platform for Use in Phase II/III Clinical Studies.” The award was presented at the AAPS 2012 National Biotechnology Conference held May 21-23 in San Diego.
-
Repligen Acquires Bioprocessing Business Of Refine Technology
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.
-
New Look At Multitalented Protein Sheds Light On Mysteries Of HIV
New insights into the human immunodeficiency virus (HIV) infection process, which leads to acquired immunodeficiency syndrome (AIDS), may now be possible through a research method recently developed in part at the National Institute of Standards and Technology (NIST), where scientists have glimpsed an important protein molecule's behavior with unprecedented clarity.
-
Evotec Acquires Cell Culture Service GmbH
Evotec AG recently announced the acquisition of all shares in Cell Culture Service GmbH (CCS), a Hamburg-based company which supports the cell culture needs of a world-wide customer base of biotech and Pharmaceutical companies.
DOWNSTREAM PROCESSING WHITE PAPERS & CASE STUDIES
-
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.
-
![BIOBlu.jpg]( "Cultivation Of Human CAP Cells: Evaluation Of Scale-Down Capabilities")
Cultivation Of Human CAP Cells: Evaluation Of Scale-Down CapabilitiesThe following application note illustrates how the DASbox Mini Bioreactor System combined with the BioBLU 0.3c single-use vessels supports bioprocess development in human cell culture.
-
![Bacteria 450x300]( "Selecting The Optimal Resins For Endotoxin Depletion In Process Purification")
Selecting The Optimal Resins For Endotoxin Depletion In Process PurificationA guide to effectively remove endotoxins with versatile process resins.
-
Compound Profiling And Toxicity
Utilizing a systems approach to drug discovery has generated a multitude of high affinity compounds for various classes of molecular targets with different degrees of disease state validation.
-
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.
-
Automation Of A Homogeneous Proximity Assay For Detection Of Residual Protein A In Biological Therapeutics
Protein A is used in affinity chromatography for therapeutic antibody purification and has been shown to leach from columns during purification of antibodies resulting in contamination. Residual Protein A in therapeutic drugs could elicit mitogenic or immunological reactions in patients.
DOWNSTREAM PROCESSING PRODUCTS
Time-to-clinic and time-to-market are two key factors in successful biopharmaceutical development.
Storage of pharmaceutical compounds is a function of the storage process and not a specific containment driven requirement per se. This is the case whether you are processing in a contained fashion or performing non-contained processing into open kegs with simple drum liners.
Capto L is an affinity chromatography medium for the process-scale capture of a broad range of antibodies and antibody fragments.
Nuvia HR-S media is a new strong cation exchanger that has been optimized for particle size and chemistry that provides exceptional resolution and high recovery.
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.