Industry Insights

1. Yugos & Dueseys: What “Classic” Cars Can Teach Us About Aging Facility Risks 12/14/2016

   With an increasing number of pharmaceutical plants having been in service for decades, the topic of aging facilities has become a major concern for regulatory agencies. And rightfully so — aging facilities can contribute to quality issues and drug shortages, among other problems. But what exactly is an aging facility?

2. Learn Pfizer’s Guiding Principles For Externalization At Outsourced Pharma West 8/4/2014

   Firelli Alonso-Caplen has been managing outsourcing for 10 years, first at Wyeth and then Pfizer. “The key really is the initial selection process for the CDMO,” she said in a recent conversation regarding our panel at Outsourced Pharma West, in San Francisco, November 10-11. 

3. How To Prevent (Or Resolve) Communication Issues With Your CMO’s Project Manager 9/18/2017

   You are on your weekly project conference call with your CMO, discussing a product-filling project which is on track. The CMO’s project manager says, “Oh, I am going to go off agenda and ask for your signature by today to go forward with a machine-testing plan. If we don’t do it tomorrow, we might need to push your production run by a couple of weeks.” This is the first you have heard of it.

4. Four Ways MedTech Can Thrive In Emerging Markets 11/26/2018

   Just two percent of the revenues generated by the top 200 medical device companies arise from emerging markets. To achieve greater success, medtech must look beyond the legacy approaches that led to success serving the billion richest patients in the world.

5. Pharmacy Compounding Vs. Manufacturing For Clinical Studies: The Regulatory Perspective 12/18/2019

   FDA requirements and compendial standards for pharmacy compounding and outsourcing continue to evolve, and the FDA has different requirements for products prepared through pharmacy compounding practices as compared to those manufactured for use in clinical studies.

6. An Analysis Of Regulatory Reforms In China’s Pharmaceutical Market 2/21/2018

   Over the past year, sweeping regulatory reforms have been introduced in China with the aim of encouraging innovation and reducing regulatory burden on the life sciences industry. The breadth of these reforms spreads across multiple stages of the drug development life cycle.

7. The Nesting Instinct 1/27/2014

   When it comes to nesting, lab mice are really not all that different than people. They crave the comforts of home, and construct nests that are sophisticated and surprisingly multifunctional. By Brianna Gaskill, Charles River Laboratories

8. Scale Matters: A Flexible Approach To Demand Uncertainty 6/5/2019

   Mid-volume capacity bioreactors offer agility in an unpredictable industry and balance the cost of goods as a program prepares to launch.

9. How Amgen Uses AI Tools To Improve Manufacturing Deviation Investigations 10/26/2018

   Amgen is piloting a process using artificial intelligence (AI) that has the potential to greatly enhance its ability to trend and find patterns in manufacturing deviations and to prevent their recurrence. The AI tool will look across large data sets and find correlations between obscure signals and events which the previous system could have missed.

10. Analyzing The Changes To Risk Management Standard ISO 14971:2019 12/11/2019

    The third edition of ISO 14971 and its updated companion report are set for release this month. ISO 14971:2019 will provide clearer guidance and greater detail in the application of risk management concepts while aligning with essential safety and performance principles.