Vaccine clinical trials with RNA-Seq endpoints to measure gene expression

Pharmaceutical companies and their drugs face numerous challenges in the brief window between launch and patent expiration. This makes it extremely important to plan lifecycle management (LCM) strategies well in advance of patent expiry. One way to address this is with advanced manufacturing techniques that make it much more difficult for competitors to genericize. For pharmaceutical companies that seek market enhancement strategies beyond the capabilities of existing fast melt technologies, join Contract Pharma for this webinar as we hear from Don Wetherhold, the senior executive advisor and senior vice president of Aprecia Pharmaceuticals. He will talk about the company’s innovative ZipDose technology and why it offers an exclusive opportunity to address patient demand and create products not easily genericized.

In this exclusive Drug Digest video interview, Meg Rivers and Felicity Thomas, Pharmaceutical Technology editors, interview experts in sterilization and aseptic processing.

The analysis of Host Cell Proteins (HCPs) has historically been performed using ELISA-based tests. A number of off-the-shelf products (e.g. Cygnus kits) are available and the testing is relatively straightforward. However, it been recognized for some time that these kits generally allow detection of a maximum of ~70% of the HCPs present in biopharmaceutical products. This is due to the fact that in any anti-HCP antibody pool, there won’t be antibodies available to cover the entire spectrum of HCP species present.

Cannabadiol (CBD) products have been in news a lot recently, but what does it take to bring a CBD product to market for an unmet medical need? This webinar will discuss development considerations for CBD and other cannabis-derived products from a clinical, preclinical (pharmacology/toxicology), CMC, and regulatory perspective.