Search results for "manufacturing"
Article
Preclinical Evaluation of Product Related Impurities and Variants
In addition, it has been reported that GCSF has a free cysteine residue (cys-17) that can trigger aggregate formation, and so post-manufacturing aggregation of GCSF is a possibility (13). Recombinant …
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Witnessing Major Growth in Next-Generation Antibodies
Nanobodies also have manufacturing advantages over other bispecific technologies, according to de Fougerolles. Because they involve a simple single heavy-chain immunoglobulin (Ig) domain, there are no…
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The Tide Stays High
Because contract development and manufacturing organizations (CDMOs) and contract research organizations (CROs) get so much of their business from externally-financed companies, the negative energy su…
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Antibody Production in Microbial Hosts
One of the most important challenges is predicting the manufacturing behavior of cell lines at early stages and selection of clones with appropriate growth characteristics. Process improvements have g…
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mAbs to Watch in 2016
Clinical-trial supplies of ibalizumab were manufactured at WuXi's biologics manufacturing facilities in China for its partner, developer TaiMed Biologics, according to a WuXi press release. The drug r…
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Using Single-Use Technologies in Downstream Processing
Jul 01, 2015
By Susan Haigney
BioPharm International
Volume 28, Issue 7, pg 24–26
The use of single-use systems (SUS) in biopharmaceutical manufacturing has been steadily increasing. W…
Article
Continuous Chromatography: Trends, Definitions and Approaches
The process parameter, both key and critical, will have their ranges validated so even during manufacturing of a single batch, changes in these parameters will be allowed as long as the product’s CQAs…
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USP Publishes Monoclonal Antibody Guidelines
Besides serving a much reduced patient population because of their specific applications, biologics manufacturing requires living material and a much more complicated process than small-molecule synth…
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Labeling of Biosimilars
… on the quality characteristics—pharmacochemical and biological properties—as determined by the manufacturing process. Under the EU’s step-wise approach to biosimilars, these characteristics and any …
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Quality by Design and Extractable and Leachable Testing
The relationship between the materials selected, the manufacturing process, and critical quality attributes are described in the design space. This defined relationship will provide assurance of quali…