One area where we see continued change in the industry is in the use of single-use (disposable) materials for processing. These materials include bioreactors, solution storage containers, filters and other items that are used for one or a few batches of production and then are replaced with new ...
Oral solid dose (OSD) form medications remain the
industry juggernaut. Though biopharmaceuticals
continue to grow and evolve, offering new and unique
treatment options, small-molecule drugs maintain their
dominance with OSD medications leading the charge.
Considering OSD drugs date back to 1,...
Toxicology studies that are carried out in compliance with the principles
of Good Laboratory Practice (GLP) are somewhat unique when compared
with most other preclinical in vivo studies. The need to achieve high
exposures, either by administering large doses of the drug molecule
or by using ...
Stability is a critical quality attribute of pharmaceutical products and is a function of many factors, including the active drug substance itself, the excipients used within the formulation, the manufacturing process employed and the drug product’s container closure system.
Many issues that the pharmaceutical drug development industry face not only affect oral solid dose manufacturing and one of the constant challenges is the scalability of new molecules emerging from the drug development pipeline.
Improvements in standards of living mean we are living longer, but as our bodies age it is most likely that we need to take medications for our ailments.