NEWS & INFORMATION
November 28, 2017
Drug Delivery Systems for Peptides and Proteins
A summary presentation of drug delivery systems with a view to understanding the specific challenges posed by administration of peptides and proteins. All routes of administration are considered
November 28, 2017
Lyophilization: Development through Technology Transfer - a QBD Perspective
A presentation examining Quality by Design challenges for the development of lyophilized products. The complexity of the process plus recent advances in technology make lyophilization quality by design a still much discussed topic.
November 28, 2017
Sterile Drug Production Practices: USP <797> vs. CGMPs
An informative presentation by Ian Devau, (FDA Bureau Chief ) regarding the differences between the cGMPs and USP<797> with respect to the manufacture of sterile drug products in compounding pharmacies and drug product manufacturing sites. The presentation raises some interesting issues for this complicated topic.