PDA Letter

September PDA Letter

The New PDA Letter Online is Coming!

Changes are coming to the PDA Letter online experience. Are you prepared? Find out what’s coming this September.

  • Profiling Leachables in Single-Use Biocontainers

    by Jian Liu, PhD, Hans Lee, PhD, Kiyoshi Fujimori, Michael Ronk, Matthew R. Hammond, PhD, and Yasser Nashed-Samuel, PhD, Amgen | Aug 27, 2015
    In the face of unprecedented competition within the industry, biopharma companies must now undergo significant transformation in order to meet the challenge of reducing costs while also providing safe and effective therapies.
    Full story
  • Science Driving New State-of-the-Art Practices for Microbial Control

    by Rebecca Stauffer, PDA | Aug 27, 2015
    While microbial contamination control in pharmaceutical manufacturing is at a level needed to ensure safe products, most would not characterize it as "state-of-the-art." An outsider taking a stroll through most pharmaceutical operations might question why 21st century products produced primarily with 21st century technologies are monitored using 19th and 20th century microbial tests. It is fair to say that this is one area where the science and its practical applications have left the industry far behind.
    Full story
  • ICH Meeting Nails Hot Topics, Hammers Out Org Changes

    by Stephan Rönninger, PhD, Amgen | Aug 27, 2015
    Twelve ICH working groups met in Fukuoka, Japan, June 5–11, to review a number of global guidelines, including four of special interest to PDA’s membership that will significantly impact the industry.
    Full story
  • Maintain Your Client/CMO Relationship in Sickness and Health

    by Karen Ginsbury, PCI Consulting | Jul 07, 2015
    Maintaining a relationship, be it friendship, marriage or otherwise, requires hard work and open communication between two individuals to be successful. Personal relationships also face numerous challenges, and, at times, can be severed by both parties for a myriad of reasons.
    Full story
  • Patient Wants Should Drive Prefilled Syringe Design

    by Walter Morris, PDA | Jul 07, 2015
    An unused drug is an ineffective drug, no matter how much it cost to develop, manufacture and administer. The late U.S. Surgeon General C. Everett Koop offered a simpler observation: “Drugs don’t work in patients who don’t take them.”
    Full story
  • FDASIA: Three Years of Success

    by Rensi Sutaria, Banner Life Sciences | Jul 07, 2015
    It has been three years since the Food and Drug Administration Safety and Innovation Act (FDASIA) was enacted. This Act expands the U.S. FDA’s authorities and strengthens its ability to safeguard and advance public health by giving it the power to collect user fees from industry to fund reviews of innovator drugs, medical devices, generic drugs and biosimilar biological products; promote innovation to speed patient access to safe and effective products; increase stakeholder involvement in FDA processes; and more. FDA has established a three-year implementation plan to help the public track the progress of these, and other provisions, established under FDASIA. As the three-year anniversary approaches, it presents a critical milestone to evaluating the success of this multifaceted law.
    Full story

Read the Full September Issue (Members Only)

For years, microbial control methods, while sufficient, have not been pegged as state-of-the-art in the industry. But new solutions and methods have entered the market.

Science

Continuous Manufacturing Reaching its Tipping Point
Hal Baseman, ValSource

Yes, You Can Design a Successful Visual Inspection Program
John Ayres, MD, Eli Lilly

Micro’s Past and Present Drives its Future State
Renee Blosser, U.S. FDA

Features

Science Driving New State-of-the-Art Practices for Microbial Control
Rebecca Stauffer, PDA

The Story Behind the 0.45 µm Membrane Pore Size Rating
Claire Fritz Briglia, EMD Millipore

Profiling Leachables in Single-Use Biocontainers
Jian Liu, PhD, Hans Lee, PhD, Kiyoshi Fujimori, Michael Ronk, Matthew R. Hammond, PhD, and Yasser Nashed-Samuel, PhD, Amgen

InfoGraphic: The Value of Import Testing versus Surveillance Testing

Regulation

Cargo Firms Vital to Drug Supply Chain
Schiphol Airport

Quality Metrics: The Discussion Continues
Anil Sawant, PhD, Merck