Search results for " drug pipeline"
Article
Innovation vs. Capacity: How CMOs Compete
The strategies of an innovation-driven CMO may be different than a capacity-driven CMO.
By Jim Miller
While industry participants and observers talk about the “CMO industry,” they know that …
Article
The Evolving Role of Starting Materials in Cell and Gene Therapy
The Evolving Role of Starting Materials in Cell and Gene Therapy
Accelerated approval pathways and growing demand for cell and gene therapies are putting pressure on providers of cellular starting m…
Article
Techniques for Improving Process Development for Exosome-Derived Therapeutics
An interview with Aaron Noyes, Head of Downstream Processing at Codiak BioSciences
Some therapeutic targets have long frustrated drug developers hoping to crack the code of mitigating un…
Article
Application of Quality by Design to Viral Safety
A quality-by-design approach defines a range of potential viral contaminants of source materials and can be used to effectively achieve viral clearance.
Oct 1, 2014
BioPharm International
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Article
Report: Branded Biopharms Most Exposed to Biosimilar Competition
In a new report on the global biosimilar drugs market, Biosimilars: Parsing the Industry's Pipelines, Moody's Investors Service reports that while biosimilar products have been launched in Asia and …
Article
Moving PAT from Concept to Reality
The learning curve for process analytical technology has slowed widespread adoption.
By Cynthia A. Challener
alexlmx a- Stock.Adobe.com
Process analytical technology (P…
Article
Cost Considerations Drive Lean Technology in Biopharmaceutical Manufacturing
By Catherine Shaffer
Four biosimilars have been approved for the market by FDA as of February 2017, and more are in the pipeline. Now that biosimilars are here to stay, manufacturers are devel…
Article
Biopharma in 2015: A Year for Approvals and Innovations
Insiders agree that 2015 was a banner year for biopharma. Last year’s new drug approvals reached 51, besting every year since 1950. Twenty approvals (39%) went to biological drugs—up from 35% in 201…
Article
Scaling Up Novel Therapies
Scaling Up Novel Therapies
Platform processes have improved monoclonal antibody scale-up. Can they do the same for personalized therapies?
By Agnes S…
Article
Preclinical Evaluation of Product Related Impurities and Variants
Preclinical Evaluation of Product Related Impurities and Variants
The approaches for sample preparation of preclinical evaluation of safety and efficacy are addressed taking into consideration the s…