Biopharmaceuticals & Biotechnology

News Brief: FDA Expands AI with Agentic Deployment

Justin Johnson, PDA

Navigating the AI Landscape

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

Driving Innovation in Pharma

Antonella Maggio, Lesirg Consultants Inc. , Beth Haas, Haas Pharma Consulting LLC , and Vinny Browning III, Amgen, Inc.

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, Kymanox Corporation

Disruptive Innovations Shaping the GLP-1 Landscape

Anya Hillery, PhD, Freelance Medical Writer

The Need for Manufacturing Speed

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

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

Enrico Barichello, Stevanato Group

Microbial Ingress No Longer an Effective CCI Test Method

Oliver Stauffer, PTI and Tyler Harris, PTI

PDA Manufacturing Meets Legislation

Dr. Bettine Boltres and Ana Marques Kuschel, PhD, WEST Pharmaceutical Services

Anticipating the 19th PDA Pharmaceutical Microbiology Conference 2024

Kurt Jaecques, MS, GSK and Erika Pfeiler, PhD, U.S. FDA

Innovation in Injectables

Laurent Jeanmart, PhD, GSK and Brigitte Reutter-Haerle, Vetter Pharma

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

Christoph Bredack, PhD, Genedata

PDA BioManufacturing Conference 2024 Lands in Gothenburg, Sweden

Sabine Hauck, Consultant and Elisabeth Vachette, Sartorius Stedim Biotech

An Alternative and Sustainable BET Designed for Patient Safety

Parampal Deol, PhD, Charles River Laboratories

Vaccine Experts’ Voice at the 2024 PDA Week

Cristiana Campa, PhD, GSK and Sabrina Restrepo, PhD, Merck

10 Museums Emphasizing Microbiology Worthy of a Visit

Tony Cundell, PhD, Microbiological Consulting, LLC

A Path Towards Improved Training Outcomes and Better GxP Compliance

Kent Malmros, Veeva Training Strategy and Iain Searle, Veeva Training Strategy

Manufacturing Capacity Expansion and Validation for Autologous Cell Therapies

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

Sterility Testing of Cell and Gene Therapies

Zachary Beck, Eurofins

Next Steps in ATMPs and Beyond

Renske ten Ham, PhD, UMC Utrecht and Richard Denk, SKAN AG

Knowledge-Driven Rapid Analytics for New Molecular Format Protein Therapeutics

Qifeng Zhang, PhD, Lonza, Lonza Biologics

Opinion: Revisit Regulatory Expectations for Micro ID in Grade A Environments for Non-growth-based Methods?

Petra Merker, PhD, Bayer AG, Tony Cundell, PhD, Microbiological Consulting, LLC, and Cynthia Martindale, Applied Rapid Microbiology Specialists, Ltd.

Challenges of Analytical Method Validation for ATMPs

Patrick Nieuwenhuizen and Christopher Rogers, PharmaLex

Continuing the Conversation for Better ATMP Development

Virginia Boldt, Accenture, Stephan Krause, PhD, Bristol Myers, and Friedrich von Wintzingerode, PhD, Roche-Genentech