Very few businesses have as specialized a set of needs as those in the pharmaceutical sector. The combination of huge product development costs, large amounts of data and intense regulatory control makes it critical for companies to have needed information as soon as possible in order to meet a varied and closely monitored set of business processes. By Todd Daviau, Ph.D
For pharmaceutical companies without their own facilities, choosing the right partner for late-phase clinical trials and commercial production is a critical consideration in developing parenteral products. This article examines some of the key criteria for selecting the right CDMO partner and includes a case study that shares some challenges involved in a late-phase technology transfer for a parenteral product.
As pharmaceutical industry faces pressure to bring new drugs to market more quickly and at minimal cost, pharmaceutical and biotechnology companies are increasingly outsourcing various parts of the drug development and manufacturing process. This white paper highlights six key points that pharmaceutical and biotechnology companies should keep in mind when looking to select the ideal partner to synthesize an API for them—and ensure their drug development process stays on the path to success.
To minimize risk and to get “true” affinity in binding analysis, we've adopted the latest innovation in surface plasmon resonance technology to develop and qualify assays for mAbs and other therapeutic proteins.
This presentation highlights how innovative protein analysis technologies have been adopted for better comparability, release testing, and impurity monitoring, to improve characterization and productivity.