Scale-Up and Site Transfer of a Semi-Solid Product for Commercial Launch

Case study
Drug product
Semi-solid dose
Tech Transfer

A company was seeking the expertise and technological capabilities of a CDMO partner to transfer and scale up the production of an existing ointment. This case presented critical challenges related to technology and site transfer that spanned development, process engineering, analytics, and quality control. Scale-up challenges included both those common to tech transfer and those unique to the production of semi-solid products.

Cambrex provided the necessary experience, skill sets, and technology to perform the in vitro release testing needed to show bioequivalence and to meet US FDA guidance for Scale-Up and Postapproval Changes (SUPAC).

Read our case study to learn how Cambrex’s advanced equipment and methods for scaling up a high-quality, high-performance semi-solid dosage form allowed the company to avoid the potential knowledge gap that can cost time and money during the transfer of a topical product to a new manufacturing site.

Be the first to receive our latest news and updates