CPA-wielding business and finance executive Dave Peralta is leading a pioneering intranasal nano vaccine developer through the advent of next-generation immunotherapies.

The forced degradation study is a vital analytical aspect of the drug development program for small molecules. Commonly known as stress testing, it is carried out to demonstrate as specificity to developed a stability-indicating analytical method, using high-performance liquid chromatography (HPLC). As per ICH Q1A, stability studies must be performed to propose the shelf life of new drug substances and/or drug products.

Very soon after publication of the FY2018 data on human tissue and cell therapy products, the FDA released the data from FY2019, which we address here. We examine data from FY2019 and a total of five years’ worth of trends in GMP inspection enforcement in this area. The regulations that govern this area, 21 CFR 1271, are the same regulations that govern segments of human cell therapy and gene therapy products. Human cell and gene therapy products are part of FDA’s Regenerative Medicine framework.

Has your supplier of primary packaging materials for medicinal products established and implemented — and continued to maintain — an adequate quality management system (QMS)? Generally, most suppliers of packaging materials maintain an ISO 9001 QMS. However, the requirements of ISO 9001 may not provide the necessary levels of good manufacturing practices (GMPs) and rigor to ensure the packaging materials are adequate for their intended use.

Blending formula and function into one neatly packaged item may seem to simplify the drug delivery process for end users, be they healthcare professionals or patients, but a product that pulls double duty comes with its own set of challenges. Combination products require their own precautions and packaging measures that help to ensure quality, safety, and reliability.

There are many reasons for issues to crop up in a supply chain. For some, there aren’t realistic, economical work-arounds available to every company to mitigate all consequences.

Cell and gene therapies have a level of complexity from a supply chain perspective that needs new approaches, including a high level of information sharing and integration. This topic was covered from different perspectives at two recent conferences.

Robert Lutz, Ph.D., is chief science officer of Iksuda Therapeutics, a 20-person start-up developing new antibody drug conjugates (ADCs) to target difficult-to-treat cancers. With an extensive background in ADC development, he believes that building mature quality capabilities is what your company must do every day from day one.

In Oct. 2019, the FDA's Drug Shortage Task Force published a report that identified root causes of drug shortages across the U.S. healthcare system and made recommendations for effectively resolving those underlying issues. This article summarizes the report's findings and discusses potential next steps the FDA may take.