Guest Columns

  1. 5 Supply Chain Questions Every Drug Company Should Know The Answers To 1/14/2020

    Part 1 of this two-part column, “They’re Not Mind Readers: Have You Told Your Suppliers What You Want?”, raised the point that if you’re not happy with one or more of your suppliers, it may be because you haven’t clearly told them what you want, what your expectations are, and what is important to you.

  2. 6 Important Elements Of The New STRONGER Patents Act 1/9/2020

    Over the past decade, patent reform has been an area of emphasis for Congress, with the passage of The America Invents Act of 2011 (AIA) and, more recently, the filing of a revised version of the STRONGER Patents Act in July 2019.

  3. 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.

  4. 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.

  5. UPDATED: New EMA Requirements On Nitrosamines — What ALL Pharma Companies Need To Know 1/7/2020

    The EMA recently issued two new publications containing information on nitrosamines for marketing authorisation holders (MAHs). Every MAH and manufacturer of chemically synthesized APIs and resulting drug products should carefully read the new EMA expectations on potential nitrosamine contamination.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. How “Two People With A Molecule” Can Build A Quality Culture 12/30/2019

    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.