PDA Letter

January PDA Letter

Podcast

Our October podcast is now available! Listen to Amgen's Madhu Balachandran discuss the future of manufacturing.

Listen to our previous podcast archive

  • Strategies for Controlling Raw Materials in Biologics Manufacturing

    by Annemarie Möritz, PhD, Novartis Pharma AG | Jan 05, 2015
    Controlling the quality of raw materials used in cell culture-based biotech manufacturing processes is a particularly challenging and critical task, because unlike traditional, small molecule manufacturing, an adventitious agent contamination event or other serious quality deviation has the potential to cause significant disruption to the manufacturing process and availability of the product.
    Full story
  • Raw Material Control Strategy Key to Overall Control

    by Parag Kolhe, Pfizer | Jan 05, 2015
    From quality risk management principles to the U.S. FDA’s recent proposals for quality metrics, industry faces pressure—both internally and externally from regulators—to ensure the quality of drug products. But quality is not just an endgame approach; it also begins at the bottom with the selection of raw materials.
    Full story
  • Task Force Corner: Task Force Hopes Revision of Aseptic Processing Points to Consider Paper is of Interest to Regulators

    by Rebecca Stauffer, PDA | Jan 05, 2015
    In 2003, PDA published the paper, “Points to Consider for Aseptic Processing” as a commentary on the then draft U.S. FDA guidance on GMPs for aseptic processing. Since then, there have been considerable changes within the industry resulting in additional knowledge, including new regulatory guidance in this area. Due to this increase in expertise, PDA has set up a task force comprised of experts in several areas to revise this document.
    Full story

Read the Full January Issue (Members Only)

The PDA Letter wishes a Happy New Year to our readers in this January issue. Learn about the control strategies for raw materials used for biologics from Annemarie Moeritz and recent pharmacopoeial updates from Europe on raw materials used for ATMP development from Rebecca Stauffer. Plus, if you missed PDA’s microbiology and prefilled syringe conferences, check out the PDA Photostream.