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Previously Featured Articles

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

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

Industry Expert Discusses the Value of the PDA/FDA Joint Regulatory Conference 2024

PDA

A Holistic Approach to CCI is a Deterministic Approach

Oliver Stauffer, PTI

FDA/CDER Readying Draft Guidance on AI to Support Regulatory Decision-Making

Justin Johnson and Walter Morris, PDA

Unleashing the Power of AI

Tejesh Marsale, PCI Pharma Services

Meeting the ATMP Moment with Robotics and Automation

Josh Russell, AST

Manufacturing Capacity Expansion and Validation for Autologous Cell Therapies

Stephan Krause, PhD, Bristol Myers Squibb and Adam Boyer, Bristol Myers Squibb, Bristol Myers Squibb