DOWNSTREAM PROCESSING FEATURED ARTICLES
GeoVax Labs, Inc. (OTCQB: GOVX), an Atlanta-based biopharmaceutical firm developing vaccines to prevent and treat HIV/AIDS, announced it has completed enrollment in a nine-patient Phase 1/2 clinical trial testing the safety, immunogenicity and ability of its DNA/MVA vaccine to elicit protective immune responses in HIV-infected individuals.
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Biotest Pharmaceuticals Announces Strategic Long-Term Manufacturing, Supply And License Agreement
Biotest Pharmaceuticals Corp. (BPC), a wholly owned U.S. subsidiary of Biotest AG (Dreieich, Germany), recently announced it has entered into a strategic long-term manufacturing, supply, and license agreement with ADMA Biologics,Inc.(ADMA).
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Novasep Launches The Sius Single-Use TFF Skid, Completing The First 100 Per Cent Single-Use TFF Solution For Pre-Clinical To Clinical cGMP Biomanufacturing
Novasep, a leading supplier of purification solutions to the life sciences industries, recently announces the launch of its Sius single-use tangential flow filtration (TFF) skid.
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Roche Medicine Avastin Receives EU Approval For The Treatment Of Women With Recurrent, Platinum-Sensitive Ovarian Cancer
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.
DOWNSTREAM PROCESSING WHITE PAPERS & CASE STUDIES
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![ANAKTAstart]( "Automating Protein Purification Processes Achieves Reliable Results And Reproducibility")
Automating Protein Purification Processes Achieves Reliable Results And ReproducibilityÄKTA start is an easy-to-use, reliable protein purification system. In this application note it is described how Erica, a post-doctoral researcher, used ÄKTA start to purify GST-tagged protein using a predefined method template, a GSTrap FF column, and a Frac30 fraction collector.
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![Optimized Purity And Recovery Of A Monoclonal Antibody Using Mixed-Mode Chromatography Media]( "Optimized Purity And Recovery Of A Monoclonal Antibody Using Mixed-Mode Chromatography Media")
Optimized Purity And Recovery Of A Monoclonal Antibody Using Mixed-Mode Chromatography MediaMonoclonal antibodies (mAbs) remain a predominant class of therapeutic protein products on the market because of their wide range of applications in disease treatment and diagnosis. Over the years, upstream technology advancements have helped improve the titer of target antibodies, from merely 1 g/L two decades ago to 10–13 g/L in fed-batch processes and up to 25 g/L in perfusion cultures today (Gronemeyer et al. 2014).
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Economic Analysis Of Single-Use Tangential Flow Filtration For Biopharmaceutical Applications Prior to creating an accurate economic model for TFF, a thorough understanding of the process where the TFF is used is needed. A process model is a valuable tool when properly executed and it must accurately include all critical aspects of the purification process. By Michael LaBreck, Mark Perreault, Novasep
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Efficiencies Of Natural Convection In Passive Pallet Shippers
Bulk transportation of temperature sensitive pharmaceuticals and biologics has become a common practice due to complex global supply chains. By Iftekhar Ahmed, Ben VanderPlas, and Stu Krupnick
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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.
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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.
DOWNSTREAM PROCESSING PRODUCTS
The ReadyToProcess WAVE 25 rocker features integrated temperature sensors and load cells, designed for convenient handling and control of cell cultures up to 25 L. A filter heater is delivered with the system.
A proven method for confirming protein purity and yield without the need for gel staining steps. Stain-free gels provide visual confirmation of protein purity and yield by gel electrophoresis in less than 30 minutes. Stain-free technology is perfect for drug discovery, drug development, and method development for preclinical research.
CHT is a leading purification medium of biomolecules in today’s demanding downstream process industry. Its mixed-mode support offers unique selectivities and often separates biomolecules that appear homogeneous with other chromatographic methods. The diverse binding capabilities of CHT for host cell proteins, leached protein A, antibody dimers and aggregates, nucleic acids, and viruses allow its use at any stage from initial capture to final polishing.
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.