DOWNSTREAM PROCESSING FEATURED ARTICLES
The U.S. Food and Drug Administration recently approved Menhibrix, a combination vaccine for infants and children ages 6 weeks through 18 months, for prevention of invasive disease caused by Neisseria meningitidis serogroups C and Yand Haemophilus influenzae type b.
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Sanofi And PATH Announce The Launch Of Large-Scale Production Of Semisynthetic Artemisinin Against Malaria
Sanofi (Euronext: SAN and NYSE: SNY) and PATH’s Drug Development program, established through an affiliation with OneWorld Health, today announced the launch of the large-scale production line of semisynthetic artemisinin at Sanofi’s Garessio site in Italy.
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New Laboratory Technique Captures microRNA Targets
Human cells are thought to produce thousands of different microRNAs (miRNAs)—small pieces of genetic material that help determine which genes are turned on or off at a given time.
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Theratechnologies Secures US Patent For Its Novel Peptide TH1173
Theratechnologies Inc. (TSX:TH)(NASDAQ:THER) today reported that the US Patent and Trademark Office (USPTO) has granted a patent (US Patent No. 8,361,964) for its second generation growth-hormone releasing factor (GRF) peptide, TH1173, providing for patent protection beyond 2030.
DOWNSTREAM PROCESSING WHITE PAPERS & CASE STUDIES
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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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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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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.
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Important Parameters For Packing Nuvia HR-S Resin At Process Scale
Process-scale production typically involves more than one column. The packing quality of each column affects the efficiency of the whole workflow and is an important validation criterion.
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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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A Purification Strategy For Clinical-Grade Monoclonal Antibody
mAbs are currently the most important class of therapeutic proteins. Advances in upstream process technologies have led to tremendous improvement of mAb titers in mammalian cell culture.