Guest Columns

1. Recommendations For Managing Complexity In Pharmaceutical Operations 1/21/2020

   There is an inherent tendency in pharmaceutical operations to make things much more complex than they need to be. “More” is considered to be better, what regulators want to see. However, more content in an SOP, additional signatures, and new forms and control loops do not necessarily equate with “better.”

2. CAR T-Cell Therapy In Non-Hodgkin’s Lymphoma: Where Do We Go From Here? 1/16/2020

   Following the success of Kite/Gilead’s Yescarta and Novartis’ Kymriah in treating relapsed or refractory diffuse large B-cell lymphoma, many key players are now pursuing development of therapies in earlier treatment settings and in other non-Hodgkin’s lymphoma subtypes, such as mantle cell lymphoma, chronic lymphocytic leukemia, and follicular lymphoma.

3. Are You Prepared For Impending Changes To U.S. Biologics & Biosimilars Law? 1/16/2020

   Sponsors for insulins and other protein products originally submitted for premarket review under an NDA may be anticipating the arrival of March 23, 2020 with trepidation. On that date, the BPCIA requires that those NDA-approved products will be deemed to have a BLA approval instead of an NDA approval.

4. Why You Need A World-Class Quality Culture — And How To Build One 1/13/2020

   The quality culture of the organization has a clear and direct impact on the ultimate quality of the product, where either the quality is built into the product or is tested against the product for acceptance. This article discusses several ideas for implementing a quality culture that is based on innovation while ensuring compliance with regulations.

5. An Introduction To Forced Degradation Studies For Drug Substance & Drug Product 1/9/2020

   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.

6. FDA FY2019 Human Tissue And Cell Therapy Observations And Trends 1/9/2020

   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.

7. Packaging Good Manufacturing Practices (GMPs) For Medicinal Products 1/6/2020

   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.

8. Pulling Double Duty: Packaging Considerations For Combination Products 1/2/2020

   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.

9. They’re Not Mind Readers: Have You Told Your Suppliers What You Want? 12/30/2019

   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.

10. The Need For Digital Networks To Support Cell And Gene Therapies 12/30/2019

    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.