PDA Letter

Features | Regulatory Challenges

Addressing Challenges in Technology Transfer for Early-Phase Cell and Gene Therapy Products

Gurinderpal Singh, GSK

Sterile Manufacturing Under Stress

Anya Hillery, PhD, Freelance Medical Writer

Three Technologies Boosting Sterility Assurance in Life-Science Aseptic Processes

David Jaworski, MBA

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Aseptic Processing & Sterilization

Sterile Manufacturing Under Stress

Anya Hillery, PhD, Freelance Medical Writer

Three Technologies Boosting Sterility Assurance in Life-Science Aseptic Processes

PDA Staff Author: David Jaworski, MBA

Optimizing Cleanroom Disinfection

Karan Khairnar, MS

Preventing Condensation in Cleanrooms

Tony Cundell, PhD, Microbiological Consulting, LLC

Setting the Standard

Katharina Schlereth

HEPA Filter Management—Industry Survey Results

Brandon L. Stiff, CSSBB

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Biopharmaceuticals & Biotechnology

News Brief: FDA Expands AI with Agentic Deployment

Justin Johnson, PDA

Navigating the AI Landscape

Peter Makowenskyj, MEng Toni Manzano

Driving Innovation in Pharma

Antonella Maggio Beth Haas Vinny Browning III

Accelerating Progress: How PDA Drives AI Innovation in Healthcare

Andrew Chang, Novo Nordisk, et al.

From Warp Speed to Uncertainty: U.S. Vaccine Policy in Crisis

Anya Hillery, PhD, Freelance Medical Writer

Disruption Potential of Injectable Anti-Obesity Therapies and Beyond

Mathias Romacker

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Manufacturing Science

Addressing Challenges in Technology Transfer for Early-Phase Cell and Gene Therapy Products

Gurinderpal Singh

Building a Business Case for a New LIMS

Justin Lavimodiere

Sponsored by Veolia

Validating Recombinant Endotoxin Reagents

Meg Provenzano

MHRA’s Decentralized Manufacturing Regulation Set to Take Effect

Munyaradzi Japondo

Teaching the Plant

Abhinav Arora

Beyond the Limits

Yanet Flor

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People

News Brief: FDA Seeks Removal of Suicidal Behavior Warning for GLP-1 RA Medications

Justin Johnson, PDA

On The Issue: Cristiana Campa Discusses Second Edition of Bestselling QbD Book

PDA

Students Step Beyond the Classroom

Tita Tavares, PDA

On The Issue: Marcia Baroni Discusses Newly Released TR-22

PDA

Reigniting PDA Puerto Rico

Justin Johnson, PDA

On The Issue: IPM Microbiology, A Talk with the Editors

PDA

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Quality and Regulatory

News Brief: EMA and FDA Unite on AI Principles to Revolutionize Medicine Development

Justin Johnson, PDA

News Brief: FDA Seeks Removal of Suicidal Behavior Warning for GLP-1 RA Medications

Justin Johnson, PDA

Ensuring Data Integrity in Pharmaceutical Microbiology Laboratories

Miriam Guest

News Brief: FDA Explores New Contracting Model to Boost Public Health Innovation

Justin Johnson, PDA

Understanding FDA Complete Response Letters

Justin Johnson, PDA

Building Maturity and Resilience Through Quality Culture

Annette Boland

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Supply Chain and Outsourcing

News Brief: FDA Launches Pilot Program to Boost U.S. Generic Drug Production

Justin Johnson, PDA

Who Picked That Supplier?

Dr. Jane Zhang Nazifa Rahman Anna Schniepp

Supply Challenges and Future Technologies in 2025

Deirdre Tobin Connie Leech

PDA Manufacturing Meets Legislation

Dr. Bettine Boltres Ana Marques Kuschel, PhD

The High Cost of Cheap Drugs

Martin VanTrieste

A Comprehensive Review of Regulatory Intelligence: Exploring Tools and Program Maturities

Jason Kerr Katie Bevard Maria Jacobs, PhD, Pfizer, Inc.

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PDA Letter's Top Articles

Three Technologies Boosting Sterility Assurance in Life-Science Aseptic Processes

PDA Staff Author: David Jaworski, MBA

Preventing Condensation in Cleanrooms

Tony Cundell, PhD, Microbiological Consulting, LLC

Setting the Standard

Katharina Schlereth, Labor LS

News Brief: FDA Unveils New Tools to Evaluate Drug Manufacturing Sites

Justin Johnson, PDA
EU GMP Annex 1. Implementation of Contamination Control Strategy

Anne Moreau, GSK Vacccines

Recent Articles (Past 60 Days)

Addressing Challenges in Technology Transfer for Early-Phase Cell and Gene Therapy Products

Gurinderpal Singh, GSK

News Brief: EMA and FDA Unite on AI Principles to Revolutionize Medicine Development

Justin Johnson, PDA

Quality & Regulatory
News Brief: FDA Seeks Removal of Suicidal Behavior Warning for GLP-1 RA Medications

Justin Johnson, PDA
Ensuring Data Integrity in Pharmaceutical Microbiology Laboratories

Miriam Guest, Charles River Laboratories

Building a Business Case for a New LIMS

Justin Lavimodiere, Veeva LIMS

Sterile Manufacturing Under Stress

Anya Hillery, PhD, Freelance Medical Writer

News Brief: FDA Explores New Contracting Model to Boost Public Health Innovation

Justin Johnson, PDA
On The Issue: Cristiana Campa Discusses Second Edition of Bestselling QbD Book

PDA
Three Technologies Boosting Sterility Assurance in Life-Science Aseptic Processes

PDA Staff Author: David Jaworski, MBA

Students Step Beyond the Classroom

Tita Tavares, PDA
Optimizing Cleanroom Disinfection

Karan Khairnar, MS, Ecolab Life Sciences

Preventing Condensation in Cleanrooms

Tony Cundell, PhD, Microbiological Consulting, LLC

On The Issue: Marcia Baroni Discusses Newly Released TR-22

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News Brief: FDA Expands AI with Agentic Deployment

Justin Johnson, PDA
Setting the Standard

Katharina Schlereth, Labor LS

Reigniting PDA Puerto Rico

Justin Johnson, PDA