Previously Featured Articles

Sponsored by Particle Measuring Systems
Normalized Data in Microbial Continuous Monitoring

Rosa Laronga, Particle Measuring Systems , Giulia Paternò, Particle Measuring Systems , and Serena Steidl, Particle Measuring Systems

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

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

Understanding Japan Quality

Antonio Burazer, Takeda

The High Cost of Cheap Drugs

Martin VanTrieste, Civica Rx

Validating NGS-Based Assays In-House for Virus Safety Assessment

Christoph Bredack, PhD, Genedata

Keep Aseptic Conditions Continuity within Transfer Procedures

Lucia Ceresa, Consultant

An Alternative and Sustainable BET Designed for Patient Safety

Parampal Deol, PhD, Charles River Laboratories

A Holistic Approach to CCI is a Deterministic Approach

Oliver Stauffer, PTI