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05.06.21 -- Why Adjusted Risk Likelihood Should Displace The Risk Priority Number


05.06.21 Why Adjusted Risk Likelihood Should Displace The Risk Priority Number
 
 
Catching up to the paradigm shift in optimizing, scaling up, and manufacturing plasmids is crucial for clinical to commercial program success for gene therapies and vaccines. With an increased demand for plasmids for targeted gene therapeutic delivery, partnering with a CDMO equipped with the capacity, expertise, and equipment for plasmid DNA production is critical to ensuring a stable therapeutic supply. Join Aji Bio-Pharma to learn about methodologies to ensure effective production and increase the likelihood of market success.
Featured Editorial
By Mark F. Witcher, Ph.D., Exyte US
While the risk priority number (RPN) primarily represents a risk event’s severity, perhaps a more important attribute to focus on is the risk event’s likelihood of occurrence. In this provocative article, Mark Witcher, Ph.D., proposes an adjusted risk lik ....

Niklas Sandler , Karima Yadi , Satu Lakio , Isidro Sanchez , Aaron Stewart , Deanna Mudie , Webinar Samsung Biologics , Hemi Sagi , Matt Hicks , Webinar Cytiva , Katie Noah , Alok Tayi , Dalton Johnson , Gibco Efficientfeed , Don Davis , Poster Ajinomoto Bio Pharma Services , Webinar Seeq Corporation , Pfeiffer Vacuum Inc , Pharma Tech Industries , Ajinomoto Co , Podcast Federal Equipment Company , Application Note Silverson Machines Inc , Pfeiffer Vacuum , Professor Niklas Sandler , Lionel Maritan , Particle Measuring ,

01.26.21 -- Top 10 Most-Cited MHRA GMP Inspection Deficiencies


01.26.21 Top 10 Most-Cited MHRA GMP Inspection Deficiencies
 
Continuing our Cell & Gene series,
Business of Biotech features Dr. Bobby Gaspar, Orchard Therapeutics CEO, speaking on the challenges his company faces in the production of hematopoietic stem cells to treat neurometabolic disorders, primary immune deficiencies, and blood disorders. Listen now and subscribe so you never miss an episode.
Featured Editorial
By Barbara Unger, Unger Consulting Inc.
In Part 1 of this two-part article, we evaluated the U.K. Medicines and Healthcare products Regulatory Agency’s GMP inspection data for 2019 and addressed the critical and major deficiencies and the annexes and chapters with which they are associated. In this part, we take the 10 chapters and annexes with the highest numbers of deficiencies and do a deeper dive into the specifics of each. ....

Russian Federation , Colins Sinclair , Webinar Coperion Coperionk Tron , Ken Langhorn , John Ward , Vladimir Putin , Don Davis , Cameron Faulconer , Ronaldj Pettis , Christianm Kelly , Aishwarya Vaidyanathan , Matt Hicks , Webinar Cytiva , Andrea Engel , Bruce Roberts , Sridhar Krishnan , Alan Tallentire , Charles Ross , Ania Vandyke , Christopherj Rini , Rick Klug , Frank Leo , Patrick Poisson , Study Of Drug Development , B Braun Medical Inc , Tufts Center ,