The new Fourier-Transform Infrared (FT-IR) spectrometer from Protagen Protein Services is used for advanced structural characterization of protein-based biologics and monitoring of vibrational modes of the amide bonds within a protein while in its native state and formulation matrix.
The new Nexera Prep Series Preparative Purification Liquid Chromatograph by Shimadzu improves prep processes for extraction of functional and impurity components, purification of target compounds in the pharmaceutical, chemical, and food industries, and productivity via flexible scalability and preparative workflow.
In this article, experts discuss the fundamentals of dissolution testing and highlight the challenges that are surfacing as a result of the increasing numbers of poorly soluble molecules entering the development pipeline.
As the development pipeline becomes more saturated with complex molecules and patient experience becomes more important, developers are looking to outsourcing partners to provide more specialized expertise and solutions.
Data supporting the quality and safety of product must meet the ALCOA+ elements in order to avoid regulatory citations for data integrity issues, says Susan J. Schniepp, executive vice-president of post-approval pharma and distinguished fellow, Regulatory Compliance Associates.