Contributing Editors

11. Choosing A CDMO: If You Can’t Answer 'Yes' To These 3 Questions, Walk Away 1/30/2020

    Choosing the right CDMO is the most important factor in the success of drug product and process development, particularly for small and virtual companies. To choose the right CDMO, you must look past the opening presentation, the facility walk-throughs, and even the compliance audit.

12. An Analysis Of MHRA’s Annual GMP Inspection Deficiencies Report 1/27/2020

    To publish the GMP deficiencies for drug product issued during its 2018 inspections, MHRA released a 6,200+ line Excel spreadsheet in October 2019. Here, Barb Unger distilled that data into easily-digestible prose, to save you the spreadsheet struggle. 

13. Navigating The Regulatory Landscape For Therapeutic Radiopharmaceuticals 1/27/2020

    There have long been numerous global and local regulations for how nuclear materials are transported, compounded, monitored, and dosed for the purpose of diagnostic evaluation. These continue to be applicable for both diagnostic and therapeutic nuclear medicines. However, establishing therapeutic medical claims for nuclear medicines increases the list of regulations that must be followed.

14. Recommendations For Managing Complexity In Biopharma Operations 1/21/2020

    There's a tendency in biopharma operations to make things more complex than they need to be. More content in an SOP, additional signatures, new forms, and control loops don't necessarily equate to better.

15. 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.

16. 5 Supply Chain Questions Every Drug Company Should Know The Answers To 1/14/2020

    Part 1 of this two-part column 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. Here in Part 2, we explore five important questions that can serve as a brief checklist to help drug companies both figure out and communicate their expectations to suppliers and understand their suppliers’ expectations.

17. 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. This article discusses several ideas for implementing a quality culture that is based on innovation while ensuring compliance with regulations.

18. 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.

19. 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.

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

    Has your primary packaging materials supplier established, implemented, and maintained an adequate quality management system? The requirements of ISO 9001 may not provide the necessary levels of GMPs and rigor to ensure the packaging materials are adequate for their intended use.