Automating Biopharma Quality Control to Reduce Costs and Improve Compliance

Paperless manufacturing is a big step for pharma companies. Manufacturers are continuously looking for innovative ways to accelerate new and existing plants and processes.

Drug formulators should consider the physical properties of their products during pharmaceutical drug development. The physical properties of a solid drug substance are highly dependent on the solid form. It is critical to understand the solid form landscape and select the optimum solid form for drug performance, stability and manufacturability as early in the development process as possible. Join this free webinar to learn about different solid forms (polymorph and salt) and different technologies to achieve these forms

After a small molecule has been identified as a viable drug candidate, substantial testing is required to assure that chemical and structural integrity are preserved throughout the drug development process to maintain its functionality. To keep a balance between quality and manufacturability, time-consuming and labor-intensive testing and analysis are required to demonstrate that chemical integrity is intact. Among the techniques used to study changes in chemical integrity are infrared and Raman spectroscopy. This webcast will discuss where efficiencies can be made in data collection, regulatory compliance, instrument qualification, method validation, and data integrity all along the development pipeline up to final quality control (QC) testing. Learn how to quickly identify changes in polymorphic structure, monitor API to excipient distribution, and troubleshoot out-of-specification (OOS) product lots, while preserving data integrity needed for audits.

Serialization is a great achievement for our industry. However, most executives now realize that it is only part of the solution, and serialization alone cannot solve the escalating problems of counterfeiting and diversion within the pharmaceutical industry. The global value of pharmaceutical counterfeiting is $200B annually. More staggering is that the gray market is forecasted to reach almost $3 trillion by 2022.