DOWNSTREAM PROCESSING FEATURED ARTICLES
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Ablynx's Anti-IL-6R Nanobody, ALX-0061, Shows Excellent 24 Week Safety And Efficacy Results In A Phase II Clinical Trial In Rheumatoid Arthritis
Ablynx (EURONEXT BRUSSELS: ABLX) today announced efficacy and safety data for its anti-IL-6R Nanobody, ALX-0061, at the 24 week final analysis of the Phase II part of a combined Phase I/II study in patients with moderately to severely active rheumatoid arthritis (RA) on a stable background of methotrexate.
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CDER-ETP: A Resource For Innovative Biopharma Firms
The FDA’s Center for Drug Evaluation and Research’s Emerging Technology Program (CDER-ETP), is yet another step toward removing slow-moving bureaucracy and red tape that stands in the way of innovative new technologies that drive drug development.
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Selecta Biosciences And Sanofi Sign Global Collaboration To Develop Antigen-Specific Immunotherapies For Up To Three Allergy Indications Based On Selecta's Synthetic Vaccine Particle Technology
Selecta Biosciences, Inc., a clinical-stage biopharmaceutical company developing a new class of synthetic vaccines and immunotherapies, recently announced that it has entered into a strategic global collaboration with Sanofi to discover highly targeted, antigen-specific immunotherapies for life-threatening allergies.
DOWNSTREAM PROCESSING WHITE PAPERS & CASE STUDIES
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Monoclonal Antibody Purification Platform Using High-Capacity Protein A And Mixed-Mode Chromatography
The first step in purification of an important class of therapeutic proteins, the polyclonal or monoclonal antibodies (mAbs), is their capture from plasma or tissue culture supernatants. Protein A–based media are by far the most common class of affinity products used for this purpose.
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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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Microbial Fermentation In Single-Use Xcellerex™ XDR-50 MO Fermentor System
This application note describes the performance of a single-use Xcellerex XDR-50 bioreactor system when used in cultivations of E. coli and of modified Pseudomonas fluorecsens (P. fluorescens) producing a monoclonal antibody (MAb). Both the achieved microbe densities and product yield were shown to be consistent with the performance of conventional stainless steel systems.
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Removal Of Host Cell Proteins During Monoclonal Antibody Purification
Protein A chromatography is a widely used and highly successful method of purifying recombinant monoclonal antibodies. However, since Protein A has high affinity for antibodies, harsh conditions such as low pH are often required to elute monoclonal antibodies from Protein A affinity columns. By 3M Purification Inc
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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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Guidelines For Proper Filtration And Delivery Of Samples To On-Line Process Analyzers
Increasingly precise process control strategies, often linked to computer control, have accelerated the use of sophisticated on-line chemical composition analyzers in plant applications. Instruments such as gas and liquid chromatographs, ion chromatographs, laser optic instruments, atomic absorption instruments and specific ion analyzers, which were rarities in laboratories ten years ago, are now found routinely in plant settings. By Ken Perrotta, Division Engineering Manager