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2018 Archive

  • January 2018
    Globalization has added layers of complexity to the pharmaceutical supply chain. The U.S. FDA and EMA are working together to ensure both regions can allocate inspectional resources accordingly through mutual reliance. The FDA’s Susan Laska spoke about this effort at the 2017 PDA microbiology conference, summarized in this issue’s cover story.
  • February 2018
    Adoption of single-use systems has grown across the industry. But the regulations still need to catch up. When it comes to sterilization validation, teamwork among all relevant parts—the pharma manufacturer, supplier, contract sterilization vendor and contract lab is essential, according to Saint-Gobain’s Polly Hanff. Plus, read content promoting the 2018 PDA Annual Meeting.
  • March 2018
    Freeze-drying is critical for the storage and distribution of biologic products. Yet the batchwise process currently dominates this area. Prototypes are available, however, that suggest continuous freeze-drying is possible.
  • April 2018
    Cell and gene therapies (also known as advanced therapy medicinal products, or ATMPs) continue to draw interest from industry, regulators and patients. In this issue, Lutz Uharek, chair of the PDA Europe Advanced Therapy Medicinal Products conference in June discusses his experience moving cell therapy production from a hospital clinic to a GMP environment. Plus, read a summary of last year’s PDA Cell and Gene Therapy Conference.
  • May 2018
    What does 3-D printing mean for biopharmaceutical manufacturing? Find out how some biopharma firms are exploring this new technology and what the regulators think in the cover story from Lina Genovesi. Also, check out articles promoting the 3rd PDA Europe Annual Meeting in June!
  • June 2018
    Ursula Busse and Melissa Seymour show how ICH Q12 might open the door to greater innovation in pharmaceutical manufacturing in this issue’s cover story. Naheed Sayeed-Desta, Ajay Babu Pazhayattil and Ivy Louis look at the benefits of a post-approval change management protocol (PACMP). Plus, check out photos from the 2018 PDA Annual Meeting.
  • July August 2018
    This issue looks at how pharma is responding to increasing supply chain complexity. Features look at the potential of blockchain to alleviate security concerns, growing global serialization requirements and a risk-based approach to managing suppliers. In addition, other content throughout the issue supports the 2018 PDA/FDA Joint Regulatory Conference.
  • September 2018
    Find out what changes USP’s Microbiology Expert Committee has planned for the USP microbiology chapters. Plus, two perspectives on the EU Annex 1 revision. And see what you missed from the 3rd PDA Europe Annual Meeting in the Photostream!
  • October 2018
    The industry has entered the age of Pharma 4.0. What does that mean for the future? This issue’s cover story addresses the implications of big data on legacy products. Also, is big data a cure for pharma’s ills? Plus, tips on how to implement Industry 4.0 solution.
  • November December 2018
    Miss the 2018 PDA/FDA Joint Regulatory Conference? Managing Editor Rebecca Stauffer summarizes a plenary talk outlining changes to the U.S. FDA’s Office of Regulatory Affairs and what these changes mean for industry.