Guest Columns

  1. How To Optimize Your Stability Program At Each Phase Of Drug Development [Checklists Included]

    A drug stability program that is above reproach is critical to successfully navigating the complexities of drug development. A well-managed stability program with thoughtfully constructed protocols demonstrates your lab and quality systems are in control.

  2. FDA’s Quality Metrics Guidance: Reading Between The Lines

    One week before we published the article 5 Important Takeaways From The FDA's Revised Quality Metrics Guidance, Life Science Connect attended a thought-provoking presentation about said guidance at a local ISPE event in Philadelphia. While the article covered several key things the guidance document did communicate to industry, the ISPE presentation focused more on what the guidance document failed to say and do … and the implications of those omissions.

  3. 4 Key Considerations When Engaging A New GMP Contract Service Provider

    This article explores what is important when establishing an effective relationship with a CSP as the program moves from product and process design to commercial manufacturing. 

  4. Are You (Inadvertently) Teaching Your Personnel To NOT Think?

    At a GxP Training and Networking Symposium, I had the opportunity to talk to a variety of people I hadn’t interacted with before. A common theme in many of my conversations was a little disturbing.

  5. Do You Make These 3 Mistakes In Your CDMO Contract Negotiations?

    Developing and launching a pharmaceutical product is a highly risky venture. Recent studies show that the overall success rate from Phase 1 to FDA approval is now less than 10 percent (Seaton, 2014), and many of those do not achieve commercial success. At the same time, the pharmaceutical industry is moving toward an outsourced manufacturing model using CDMOs (contract development and manufacturing organizations), which further compounds the risks by adding knowledge transfers, competing priorities, and lack of control. Building strong and mutually beneficial outsourcing partnerships is crucial to achieving success for small, midsize, and even Big Pharma companies.

  6. Integrating Risk Management In The Quality Management System — A Primer

    This article will first present the definitions and requirements regarding risk and then introduce some tools that can be utilized to incorporate and integrate risk management techniques in and throughout the QMS.

  7. Interacting With The FDA — Best Practices For Drug Development Success

    When it comes to dealing with and interacting with the FDA, attitude plays an important part in ensuring the agency is on your side. How do you do this?

  8. Measuring The Impact Of Recent Regulatory Guidances On Quality Systems

    This article summarizes opinions on how well specific regulations have impacted operations and looks at the general health of some key quality management system (QMS) elements that are described and proposed in these regulations. 

  9. Outsource Or Insource? Finding The Sweet Spot

    Pharma companies are constantly evaluating manufacturing strategies for more cost-effective drug development and manufacturing operations. They recognize the need for flexibility and value the opportunity to base outsourcing or insourcing decisions on the ability to deliver the highest quality service rapidly and at the lowest price.

  10. Cell Therapy: Process Design Considerations To Support Commercialization

    Cell therapies have the potential to revolutionize the biopharmaceutical world, but today’s processes, logistics, and delivery make for a challenging entry into the sector’s growth curve. As the industry evolves, we have to answer (at least) three important questions when bringing these exciting new therapies to market.