Pharmacologist US Food and Drug Administration Silver Spring, Maryland
The Bupivacaine HCl collagen implant (XARACOLL) is a matrix-type drug delivery system designed to manage post-surgical pain. The matrix of the implant consists of purified Type I collagen. The physical and chemical properties of Type I collagen may vary depending on the source, method of extraction, and processing conditions, which may impact the critical quality attributes (CQAs) of the collagen implant such as the morphology, porosity, drug localization, and performance characteristics including in vitro drug release.
This presentation will highlight a case study focusing on the evaluation of Qualitative (Q1) sameness across commercially available collagen from various sources and its impact on the CQAs of the Bupivacaine collagen implant. Advanced AI image processing and segmentation techniques will be discussed, demonstrating their effectiveness in measuring the porosity, drug localization, and drug release from the collagen implants.
Learning Objectives:
Attendees will gain practical insight into different characterization approaches for evaluating Q1 sameness of collagens.
The presentation will also provide an in-depth understanding of the manufacturing complexities associated with collagen implants and strategies to address these challenges.
How AI image analysis and segmentation can be used to emeasure porosity, pore size distribution and drug localization in the collagen implant.
