DOWNSTREAM PROCESSING FEATURED ARTICLES
The data from BioPlan Associates’ 12th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production speaks to the industry’s ongoing desires for standardization in single-use devices. As usage of these disposable devices increases, the gap between the importance of standardization and end-users’ satisfaction with their supplier’s standardization efforts has steadily been worsening.
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Rapid Single Molecule Haplotyping A technical poster from Fluidigm Europe entitled 'Rapid single-molecule haplotyping in patients with sickle cell disease' reports upon the pioneering work of Dr Stephen Menzel and his fellow researchers at Kings College (London), School of Medicine.
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Scientists Help Identify A Missing Link In Taste Perception
Working with a multidisciplinary consortium of 19 researchers from nine institutions, Monell scientists have provided critical information to identify CALHM1, a channel in the walls of taste receptor cells, as a necessary component in the process of sweet, bitter, and umami (savory) taste perception.
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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.
DOWNSTREAM PROCESSING WHITE PAPERS & CASE STUDIES
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![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.
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Continuous Harvesting Of Extra-Cellular Proteins From Mammalian Cell Cultures Utilizing Small-Scale Perfusion
The use of a small-scale cell culture system not only maximizes the production of valuable protein but also avoids the high capital cost associated with system scale-up. Continuous harvesting can provide significant improvements in protein yields when compared to those of typical batch operations.
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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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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
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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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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
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.