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.

• 2021’s Bioprocessing Year In Review & 7 Key Takeaways

  The biopharma and bioprocessing industries have responded aggressively and effectively to the COVID-19 pandemic. However, supply chain challenges, shortages, hiring problems, and regionalization have accelerated existing trends and created the need for new strategies. These are just a few of the findings presented in BioPlan Associates’ 2021 18^th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production.

• 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.

• How To Integrate CPV & APR For Biologics

  In biologics manufacturing, continued process verification (CPV) requirements are similar to those for evaluating quality standards that determine changes to manufacturing or control procedures in an annual product review (APR). Many companies have mirrored CPV and APR reporting processes. Few have realized the efficiencies of integrating them. 

• wNMR: Spectroscopy From Biomanufacturing to Point-Of-Care

  Biomolecular NMR spectroscopy work requires highly trained personnel. Sample preparation can be laborious, as biomolecules often require isotopic labeling/enrichment. High-field NMR spectroscopy isn't well suited for manufacturing plants or clinics. Enter wNMR, a noninvasive analytical technology that operates in settings where others are ill suited. 

• 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.

• 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.