Product Development

Video
One Size Does Not Fit All: Strategies for Bringing Advanced Therapy Medicinal Products to Market The number of advanced therapy medicinal products (ATMP) on the global market is fewer than expected despite the large...
Features

This article is Part 1 of a two-part series exploring what we can learn from examples of pharmaceutical products being approved using accelerated programs. The series focuses on challenges that chemistry, manufacturing, and control (CMC) development teams may encounter when a project is given accelerated development status. Part 1 introduces key considerations and themes in general terms and...

Insights

Initially, the American College of Rheumatology urged caution around the use of biosimilars. Information about the manufacturing process for a branded biologic is proprietary; a biosimilar manufacturer will not have access to the details of the process, so how could they guarantee their product would be the same? It is now well accepted by the scientific community that biosimilars are safe,...

Technical

As the global population demands faster and more affordable drugs, biopharmaceutical companies are continually trying to find ways to produce their drug products more economically and efficiently. Today, the competition and need for drugs are greater than ever before. Companies have been considering operational alternatives to reduce production costs and increase manufacturing rates.

Technical

Sampling is the selection of a representative portion of the population to make inferences about the entire population. In pharmaceutical manufacturing, samples are drawn from different stages of the process for both controlling process parameters and assessing drug product quality. In the case of a traditional batch process, a fixed amount of material is processed and the batch quality is...

Technical

High-pressure liquid chromatography employing the multicolumn countercurrent solvent gradient purification (MCSGP) process principle has been developed as a novel purification technology for peptides produced by chemical synthesis. MCSGP offers a step change in efficiency compared to batch high-performance liquid chromatography (HPLC) processing. With MCSGP, two identical reverse-phase (RP)...