Search results for " regulators" in Articles / App Notes
Article
A Q&A with Eric Langer: CMOs Embrace New Technology
Process Development Forum speaks with Eric Langer, President and Managing Partner at BioPlan Associates, and the author of a number of biopharma studies, about the 2016 13th Annual Report and Survey…
Article
Reporting Quality Metrics to FDA
Siegfried Schmitt, Principal Consultant, PAREXEL International, discusses how to report quality metrics to FDA.
By Siegfried Schmitt
Q: We are a contract manufacturing organization (CMO), sp…
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Vaccine Development Faces Urgency and Challenges
Global outbreaks energize vaccine R&D and drive production modernization.
By Jill Wechsler
The Ebola outbreak in 2015 and the current stampede to develop a new vaccine to combat the Zika vir…
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Innovative Therapies Require Modern Manufacturing Systems
FDA and industry see progress and challenges in bringing cutting-edge medicines to patients.
By Jill Wechsler
FDA set a 19-year record in 2015 in approving more new drugs and biologics, and …
Article
CMOs Concerned With Cost of Single-Use Equipment
Cost factors are right up there with product quality, on-schedule delivery, and the provision of L&E data that regulators will accept. However, for this industry, and most others, cost factors are a c…
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Advanced Technologies Facilitate Scale-up and Technology Transfer
Fortunately, by working closely with tools and technologies suppliers and the regulators, biopharmaceutical manufacturers are better positioned to overcome such challenges,” Galliher asserts.
Sing…
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Biomanufacturing Outsourcing Globalization Continues
May 02, 2015
By Eric S. Langer
BioPharm International
Volume 28, Issue 5
Biopharmaceutical manufacturing clusters continue to emerge outside of the traditional hubs of North America …
Article
Use of Multivariate Data Analysis in Bioprocessing
The increasing use of MVDA has also been fueled by the increasing acceptance of quality by design (QbD) and process analytical technology (PAT) among regulators and the biotech industry. Implementatio…
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Drug Discovery and Development in India
Apr 01, 2015
By Jane Wan
BioPharm International
Volume 28, Issue 4
Indian pharmaceutical companies’ entry into the drug discovery and development field dates back to the early 1990s …
Article
Tackling Analytical Method Development for ADCs
In addition, as more products make it into the clinic and then into the market, Jacobson expects that regulators will become more familiar, and more comfortable, with the ability of current analytical…