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Glycosylation of therapeutic proteins is important to biologic drug development and is a critical quality attribute that is monitored during manufacturing. Analysis of O-glycans is technically challenging compared to that of N-glycans. In this review, Xiaofeng Shi, Saulius Vainauskas and Christopher H Taron summarise current O-glycan analytical approaches, describe the…
Dave Elder outlines how bioequivalence data supports numerous processes at various stages of drug development as well as when establishing generic drug substitution, and reflects on its differing interpretations across the globe.
Implantable systems and microparticle depots are used in many areas of drug delivery to release medicines at a controlled rate within the body. The use of these long-acting dosage forms eliminates the need for frequent administrations via traditional routes of administration, which ensures patient compliance and results in improved outcomes.…
Extractables and Leachables Safety Information Exchange (ELSIE) has been the most influential industry group in developing guidelines for extractables and leachables. In the wake of the ICH convening a new group to develop a concept paper and business plan on their Q3E Impurity Guideline, Dave Elder discusses the strides that…
The International Council on Harmonisation (ICH) is drafting guidance for product lifecycle management (ICH Q12) – currently stage 2b, which requires application of the concepts of Quality by Design (QbD) to ongoing lifecycle management and change control. Dave Elder dissects the guidance and discusses considerations for industry professionals.
