Search results for " approval"
Article
Moving PAT from Concept to Reality
…r to focus their investments on candidates that have the greatest likelihood of obtaining regulatory approval. By reducing process development timelines, PAT is making it possible for companies to ta…
Article
Science Focus Fuels Successful Process Development for Startups
…stem-cell therapy that it took from preclinical development to two Phase II trials in Europe and FDA approval for an investigational new drug (IND). “What we learned while carrying out tech transfer,…
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A Plastic Pipeline for Commercial Bioprocessing?
Adoption for commercial production has been slow; however, as more therapies developed under single-use processes move toward regulatory approval, industry experts expect the percentage of biologic-ba…
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Biopharma Says It Has an Evolution in New Technologies and Processes
Q: How are equipment and materials suppliers meeting the demand for emerging drug therapies?
A: FDA’s approval in 2017 of cell- and gene-therapies created a great deal of excitement in the industr…
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Modern Manufacturing Key to More Effective Vaccines
Modern Manufacturing Key to More Effective Vaccines
Accelerated development of new preventives raises challenges for efficient CMC evaluation and production.
By Jill Wechsler
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Article
The Tide Stays High
Acquired or in-licensed products account for a third to a half of product approvals gained by global bio/pharma companies in recent years, and their reliance on externally-sourced candidates appears t…
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Managing Biomanufacturing Capacity Expectations
The researchers found that demand for oncology drugs was most commonly underestimated, most likely because of the additional indications for which these drugs earned approval by FDA after initial laun…
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Lessons Learned Accelerate Vaccine Development
Two specific examples that benefited Janssen included the collaborative approach that was taken to gaining regulatory approvals and a new structure for the production and facility refurbishment teams.…
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A Risk-Based Genetic Characterization Strategy for Recombinant CHO Cell Lines Used for Clinical and Commercial Applications
The authors describe the ways in which manufacturers can mitigate the risks related to the integrity of recombinant transgenes expressed in CHO cells.
By Luhong He, Christopher Frye
Abstract
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GMP Challenges for Advanced Therapy Medicinal Products
Defining manufacturing quality
Senior members of the European Medicines Agency, which is responsible for the EU’s centralized approval procedure, have hinted that different concepts of manufacturin…