Planning Successful Launches of Complex Drug Products

Using directed integration of antibody genes by CRISPR/Cas9 and TALENs, the construction of large libraries in mammalian cells containing a single antibody gene/cell has been achieved. This accomplishment has enabled the construction of libraries containing millions of monoclonal, stable, cell lines displaying IgG-formatted antibodies on their surface, and from which novel, high-affinity binders can be isolated. This technology also allows for the selection of antibodies with improved biophysical properties from libraries of variants.

On Tuesday, June 18, 2019, our team of legal professionals and industry experts hosted a Compliance Considerations for Pharmacy Sale or Acquisition Webinar that took a look at the regulatory pitfalls and problems that can arise in a pharmacy transaction.

Cryo-electron microscopy (cryoEM) is a Nobel Prize-winning technique for solving high-resolution three-dimensional structures of biological molecules such as proteins, that is used for structure-based drug design. Key to the success of cryoEM are significant advances in high performance computer vision and machine learning algorithms, used to extract information from large numbers of noisy 2D microscope images and compute and refine 3D structures of target proteins in near-native states.

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.