Search results for " biologic" in Articles / App Notes
Article
Manufacturers Struggle with Breakthrough Drug Development
31, 2014, manufacturers submitted 140 requests for breakthrough status for drugs and biologics; the agency has approved 39 of these, approximately 30%, and denied 76. New approvals in 2013 included th…
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Predicting Progress in Protein Aggregation
As the development of biologic drugs based on antibodies and other protein/peptide molecules continues apace, the control and prevention of aggregation during manufacturing, downstream processing, for…
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Biotechnology Innovation and Growth in Israel
Key regulatory considerations
New drugs registered in Israel, including biologics, must meet European Union (EU) standard GMPs in terms of quality and efficacy to ensure public safety. In ad…
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Comparing Protein A Resins for Monoclonal Antibody Purification
Today, mAbs constitute the single largest class of biological drugs and accounts for about 36% of the total biologics market with an annual sales growth rate of approximately 10% (4).
Com…
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Quality by Design: A CMO's Perspective on Gaining Knowledge Faster and Better
…s Schmid, and Michael Larson are development associates, all in the Process Development Group at CMC Biologics, http://www.cmcbio.com/.
REFERENCES
1. FDA, Draft Guidance for Industry: Targe…
Article
Milestones and Moderate Progress in 2012 Drug Approvals
However, it was assessed and approved in the US as an original biologics license application (BLA), because a biosimilar pathway was not available to the sponsor at the time of submission to the regul…
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Evaluating the Use of Continuous Chromatography
had earlier noted that “Rapid advances in intensifying upstream processes for biologics production have left downstream processing as a bottleneck in the manufacturing scheme” (2). But to increase eff…
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Impurity ELISA automation for faster process development
Host cell proteins (HCPs) produced by cells during biologic manufacturing must be removed from the final product to protect patients. However, it’s challenging to detect HCP, and this step can…
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Pulling Out All the Stops in mAb Manufacturing
While the biopharma industry is pushing the barriers with antibody development, it must also contend with contemporary challenges in bulk monoclonal antibody (mAb) manufacturing. The need for…
Article
Host cell protein quantitation using ELISA
Host cell proteins (HCPs) produced by cells during biologic manufacturing must be removed from the final product to protect patients. However, it’s challenging to detect HCP, and this step c…