Distinguishing E&L Testing for Combination Products (AAPS PharmSci 360)

Speaking with Pharmaceutical Technology® at AAPS PharmSci 360, Dujuan Lu, PhD, global leader—E&L, SGS Health Sciences, reviewed the difference between establishing extractables and leachables (E&L) testing for combination products and conventional single/simplified drug products.

“If you only have just a drug product,” she explains, “you only need to consider the extractables and leachables portions for a drug product or regulation. You know the pharmaceutical packaging perspective or maybe the manufacturing process material as well.”

“However,” she continues, “if you are dealing with drug­device combination products, you need to consider both aspects, you need to work on the drug perspective and also the device perspective. And this [will] really depend on the primary mode of action, [such as] whether you need to put more focus on the drug side or more focus on device side.”

A combination drug product is more complicated and definitely requires consideration for both aspects, she states. “In my talk, we're talking about different regulations for different types of study design in terms of the drug versus device. So, all aspects need to be consideredduring the study design for combination products.”

Lu was featured as a speaker at AAPS PharmSci 360, where she gave a talk, “Regulatory Expectations in Extractables and Leachables Testing of Combination Products.” In her talk, she discussed chemical characterization, per ISO 10993-18, which has become important in biocompatibility testing for medical devices. One of the key points in her talk was on the differences and similarities of E&L study designs between medical devices (based on ISO standards) and drug product ( based on USP standards). She also discussed the need for understanding the recent regulatory expectations on E&L testing of medical devices and combination products.

AAPS PharmSci 360 ran Oct. 22–25 in Orlando, Fl.

View Lu’s video interviews on E&L considerations during formulation and E&L study design between ISO and USP.