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 likelihood rating approa
05.04.21 How To Ensure Your Quality Culture Assures Data Integrity
Several biopharma startup veterans share their insight and inspiration on navigating clinical-stage regulatory considerations in this ebook.
Find advice and wisdom from biopharma leaders on:
Chemistry, manufacturing, and controls (CMC) considerations for first-in-human studies,
Gap analysis fundamentals,
And the relationship between GMP and CMC.
Join Biotech Makers to network, share expertise, and get perspectives on common challenges. Collaborate and connect with your peers. Join Now.
Featured Editorial
By Chris Smalley, ValSource
One solution to ensuring data integrity is to automateBr processes, essentially removing the human element. But not all instances of data generation and capture can or should be automated. With humans our team members engaged in data generation and capture, the quality culture is a major pathway