GUEST COLUMNISTS

• Merck’s 2 Lessons Learned In Overcoming Single-Use Materials Supply Challenges

  The COVID-19 pandemic has caused severe disruption to supply chains, making it difficult to get material. At Merck, a situation occurred recently wherein they were unable to get the filter assembly they needed, and their supplier was struggling to meet demand. This article shares Merck's two lessons learned from the experience.

• Calculating Cleaning Process Capability: Analysis Of Total Organic Carbon

  This article will examine a data set of actual total organic carbon (TOC) swab data collected during cleaning validation for a pharmaceutical manufacturing facility and will show how much cleaning process knowledge and cleaning process understanding can be easily obtained through some simple statistical evaluations of such data.

• Congressional Bill Supports Biopharma Advanced & Continuous Manufacturing

  The House recently passed H.R. 4369, which authorizes $100 million over four years to establish National Centers of Excellence in Advanced and Continuous Manufacturing at U.S. academic institutions. This article delves into the news and how it fits into other U.S. initiatives supporting the field.

• EPCIS Implementation: 4 Takeaways, Next Steps For DSCSA Compliance

  With the Nov. 27, 2023, DSCSA deadline quickly approaching, the HDA Research Foundation recently released a survey to assess how the industry is preparing. This article summarizes the 4 key takeaways as well as your next steps for DSCSA compliance.

• Method-of-Treatment Patents: Increasing Value & Risk

  Patents on methods-of-treatment using pharmaceuticals are being asserted in broad ways against a variety of parties, with potential liabilities of hundreds of millions of dollars. Method patents can be obtained not only for new indications but also for other discoveries made after the initial approval, like dosing regimens. 

• How AstraZeneca Optimized Vapor Phase Hydrogen Peroxide Gassing Cycle Development

  Demonstration of efficacious decontamination is a critical aspect of aseptic processing and sterility testing. By adopting enzyme indicators in the cycle development phases, greater understanding of efficacy of the gassing process can be achieved by providing quantitative results in a faster time frame. Here's how AstraZeneca did it.

• The Data Integrity Body of Knowledge Expands with New & Pending Guidances

  Some of the contemporary guidance documents for data integrity in biopharmaceuticals and medical devices, both released and in draft, are explained here to better understand their scope and relationship to one another and to provide an example of the ever-changing landscape of data integrity challenges and potential solutions.

• The EU’s Biopharma Industry Can Deliver More With IDMP Data Standards

  Promises abound in the IDMP software industry about the vast transformation potential of data-driven processes beyond pharma regulatory exchange. Biotechs, unencumbered by legacy systems and processes, could blaze a trail. This article provides the steps to take now.