PDA Letter

May PDA Letter

Podcast

The April PDA Letter podcast is now available! Hear Pfizer’s Michael O’Brien discuss the company’s use of portable pods for manufacturing.

Listen to our previous podcast archive

  • Quality’s Role as Financial Officer – Can you speak $, €, £, ¥, CHF?

    by Jennifer Magnani, Sanofi Pasteur, and Anders Vinther, PhD, Sanofi Pasteur | Apr 23, 2015
    Why is it that Finance and Quality are seen as immiscible as oil and water? Rarely do you experience a financial discussion in a Quality meeting setting. Likewise, rarely do you see a cGMP compliance or quality discussion when the organization gets together to discuss budget. Having financial discussions with Quality professionals is generally linked to production volumes and the cost of the Quality organization as overhead.
    Full story
  • Key Considerations for Successful Technology Transfers

    by Jose Caraballo, Bayer HealthCare | Apr 23, 2015
    The pharmaceutical industry is constantly engaged in transferring processes between organizations or locations; these transfers are critical to get product to market. The number of transfers is expected to increase as countries act on the need to manufacture drug products locally. This activity is part of the normal lifecycle of a drug product, and it can range from very successful transfers to problematic ones, based on a myriad of factors. Among them are process and product robustness, the readiness of organizations to engage in transfer activities, availability of experts, and the timely execution of all the work needed to complete a transfer.
    Full story
  • Technology Innovation: Automated Isolator with Robotic Arm Offers New Options

    by Rebecca Stauffer, PDA | Apr 23, 2015
    It is no revelation to say that the age of robotics and automation is underway, as many assembly line industries have utilized production robots in one form or another for several decades. Yet pharma manufacturing remains heavily human. Robotic systems, however, can offer solutions to problems caused by the human element, such as the problem of microbial contamination in aseptic processes.
    Full story

Read the Full May Issue (Members Only)

As the industry moves away from traditional models of manufacturing, having an effective technology transfer plan will be essential.

Science

Automated Isolator with Robotic Arm Offers New Options
Rebecca Stauffer, PDA

Regulators, USP Looking Increasingly at Visual Inspection
John Shabushnig, PhD, Insight Pharma Consulting, and Markus Lankers, PhD, rap.ID GmbH

Examining the Current State of Monoclonals
Martijn van der Plas, Dutch Medicines Evaluation Board, and Michael DeFelippis, Eli Lilly

Ebola Crisis Offers Lessons Learned for Industry, Regulators
Edward Balkovic, PhD, Genzyme

Tackling Sterility Concerns of Compounding 
Austin Caudle, NSF Health Sciences

Features

Key Considerations for Successful Technology Transfers 
Jose Caraballo, Bayer HealthCare

Portable Pods Part of New Strategy for Pfizer 
Rebecca Stauffer, PDA

Quality’s Role as Financial Officer – Can you speak $, €, £, ¥, CHF? 
Jennifer Magnani, Sanofi Pasteur, and Anders Vinther, PhD, Sanofi Pasteur

Infographic: 6 Obstacles to Avoid for Successful Tech Transfer

Regulation

FDA, Industry Entering Changing Times: Are You Prepared? 
Steven Mendivil, Amgen, and Alicia Mozzachio, U.S. FDA