
Key E&L Issues to Consider During Formulation (AAPS PharmSci 360)
Dujuan Lu, PhD, global leader—E&L, SGS Health Sciences, recommends some key issues that pharma manufacturers should consider when formulating products that require a medical device.
Speaking with BioPharm International® at AAPS PharmSci 360, Dujuan Lu, PhD, global leader—E&L, SGS Health Sciences, gave her views on what key extractables and leachables (E&L) issues pharma manufacturers should keep in mind, from a regulatory standpoint, when formulating a pharmaceutical that requires a medical device for drug delivery.
She points out that, for any drug product that uses a device as a drug delivery system, a pharma manufacturer will need to consider extractable/leachable testing for both aspects. “You need to conduct your extractables and leachables study for your container closure system for the drug product, but, on the other hand, you need to work out your extractables and leachables for your drug delivery device,” she says.
That that end, a pharma manufacturer may need to consider the regulations in place for that device and then design its E&L study that is applicable to that portion. “You need to consider both aspects in that case,” Lu recommends.
Lu was featured as a speaker at AAPS PharmSci 360, where she gave a talk, “
AAPS PharmSci 360 ran Oct. 22–25 in Orlando, Fl.
View Lu’s video interviews on
Newsletter
Stay at the forefront of biopharmaceutical innovation—subscribe to BioPharm International for expert insights on drug development, manufacturing, compliance, and more.