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
04.27.21 Life Sciences Investment Outlook: Deal-Making Gets Creative
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 Jeff Stoll and Kristin Pothier, KPMG
Life sciences companies remain unabated when it comes to creatively making deals during the COVID-19 pandemic, particularly among those targeting biopharma companies with early-stage assets. Check out this article highlighting takeaways from the KPMG 2021
04.22.21 Tools And Best Practices For Trending Environmental Monitoring Data
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 Crystal M. Booth, PSC Biotech
Environmental monitoring (EM) trending is an essential component of the EM program and can be used to evaluate the overall health of the facility in terms of microbial control. Part 1 of this series looked at the regulations and guidelines around EM. This article discusses tools and b
04.20.21 FDA Inspections: Are Changes On The Horizon?
To get the most out of data, you must ensure they are findable, accessible, interoperable, and reusable F.A.I.R. for short. Organizations simply don’t have the infrastructure in place to be able to capture data with context and then store them so that they can be searched and accessed with ease. We’ll explore how you can change that using the F.A.I.R. principles, which have been recognized as standards to enable for that potential to be realized.
Featured Editorial
By Kalah Auchincloss, Greenleaf Health, Inc.
A year into the pandemic, the FDA is still conducting only limited inspections in the U.S. and evidence has emerged of a significant inspection backlog that could compromise the safety and quality of the U.S. drug supply. Kalah Auchincloss of Greenleaf Health provides a brief timeline of inspection-related events over the last year, discusses the impact, and examines the c