01.16.23 -- Unpacking ICH's Final Q13 Guideline For Continuous Manufacturing

The $118 billion combination product market is projected to increase at a compound annual growth rate (CAGR) of 8.8%. This article answers the questions: “Is this actually a combination product? What do we need to do if it is?”

By transitioning to alternative solvents or leveraging process aids, the challenges associated with the use of these chemicals can be addressed, helping create a sustainable, greener footprint.

Successful tech transfer is how long-term strategic CDMO relationships begin. A product’s continued success may hinge on this critical exchange of product data and required regulatory filings.

In this article, Dr. Kashif Ghaffar, process validation pharmacist at Pfizer’s Freiburg facility, discusses what needs to be considered during product development in preparation for commercial manufacture.

From sensors and software to data-based services throughout production, Industry 4.0 solutions are opening new potential in terms of transparency, quality, safety, and efficiency.

It is critically important to understand the significant competitive advantages of FDC products and the difficulties and potential pitfalls associated with their development and manufacturing in oral solid dosage forms.

A QbD approach was used to solve a high-performance liquid chromatography analytical method problem where impurity peaks had shifting retention times, making identification and quantitation problematic.