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Previously Featured Articles

Sponsored by Veolia
Validating Recombinant Endotoxin Reagents

Meg Provenzano, Veolia

Three Technologies Boosting Sterility Assurance in Life-Science Aseptic Processes

PDA Staff Author: David Jaworski, MBA

Setting the Standard

Katharina Schlereth, Labor LS

Understanding FDA Complete Response Letters

Justin Johnson, PDA

PDA Capital Area Chapter Roundtable on Complete Response Letters Draws a Large Sunday PM Audience

Walter Morris, PDA

HEPA Filter Management—Industry Survey Results

Brandon L. Stiff, CSSBB, Merck & Co.

Managing Ready-to-Use (RTU) Containers in Aseptic Production Facilities

Alliance for RTU and IMA Life

Three Sterility-Enhancing Technologies for Aseptic Life-Science Processes

PDA Staff Author: David Jaworski, MBA

Who Picked That Supplier?

Dr. Jane Zhang, ETCH Sourcing , Nazifa Rahman, ETCH Sourcing , and Anna Schniepp, ETCH Sourcing

Supply Challenges and Future Technologies in 2025

Deirdre Tobin, Compass Pharma Consulting Ltd and Connie Leech, CAI

Equivalence Testing of BFPCs in Grade A Environments

Mads Lichtenberg, PhD, Fujifilm Biotechnologies, et. al.

Harnessing HACCP for Aseptic Filling

Abu Sadat Muhammod Saiyem, Square Pharmacuetical Limited

Disruptive Innovations Shaping the GLP-1 Landscape

Anya Hillery, PhD, Freelance Medical Writer

Effective AI Deployment in Drug Manufacturing

Peter Makowenskyj, MEng, G-CON Manufacturing and Toni Manzano, PhD, Aizon

Engineering Excellence in Container Closure Integrity Testing

Oliver Stauffer, PTI

The mRNA Revolution

Amisha Patel, Sanofi

The Need for Manufacturing Speed

Michael Anyadiegwu, PhD , Renske Hesselink, PhD , and Ingrid Kromann, CEPI

Expert Perspectives in KM Between Sponsors and Third Parties

Dr. Bettine Boltres , Danica Brown , Beth Haas, Haas Pharma Consulting LLC , Marty Lipa , Rhonda Sundberg , and Joseph Thomas, PDA Knowledge Management Roadmap Team

Ethical Dilemmas in Pharma: Pharma's Toughest Decisions

Martin VanTrieste, Civica Rx

Challenges in Sterilizing Indirect Product-Contact Surfaces

Cecilia Pierobon, STERIS

From Lab to Market

Tejesh Marsale, PCI Pharma Services

Uncovering the Symbiotic Link Between KM and AI

Marty Lipa , Anne Greene , Paige Kane , Michele Simone, PhD, Bracco , and Toni Manzano, PhD, Aizon

Five Important Insights from the PDA Europe Annex 1 Event

Patrick Nieuwenhuizen, PharmaLex

GMP Annex 1 Implementation

Andrea Salmaso, Stevanato Group

Modern Microbial Methods Supporting a Contamination Control Strategy

Allison Scott, Particle Measuring Systems, et al.

Points to Consider When Applying QRM

Douglas Campbell, InterPro QRA

Knowledge-Driven Impurity Control for NMF Protein Products

Qifeng Zhang, PhD, Lonza, Lonza Biologics

Breaking point: Assessing and Addressing the Risk of Auto-Injector Failure

Enrico Barichello, Stevanato Group

Q&A on the Revised PDA Technical Report No. 22

Subrata Chakraborty, PhD, INOVR , Vanessa Figueroa, VVF Science , and Marcia C. Baroni, MBA, Emergent BioSolutions Inc

Microbial Ingress No Longer an Effective CCI Test Method

Oliver Stauffer, PTI and Tyler Harris, PTI