QbDVision Blog

Our industry faces numerous challenges related to scaling manufacturing processes for cell and gene therapies. Explore some key recommendations and potential solutions.

Yes indeed, CherryCircle just knocked out an additional round of seed financing. Combined with our last raise, brings our total fundraising to around $4.6M.

Today, the FDA issued temporary guidance on the resumption of normal manufacturing operations during the COVID-19 health emergency.

There is a consistent theme that comes up in the world of pharmaceutical process development and validation: a pervasive confusion around how ICH guidelines match up with quality-by-design principles.

We’re excited to announce the next major iteration to QbDVision. Designed and validated top to bottom to bring you the latest tools to advance your pharmaceutical manufacturing activities.

See how our platform builds risk in discrete layers that are designed to be updated and managed throughout the development lifecycle thus capturing the evolution of risk.

Explore how the structure of risk configuration in QbDVision produces easily understandable assessments to guide future work.

Last week, we saw how capturing uncertainty and detectability risk brings clarity and dimension while assessing risk when used appropriately. This week, we will look at the practical aspects of process risk assessments from a different lens: that of the people executing or using these tools.

Last week we explored how the concepts we’ve been discussing in our series line up with FMEA/FMECA methodologies. This week, we’ll explore the two impostors, uncertainty and detectability risk, a little bit further.