Data Integrity

Data Integrity: Drivers, Challenges, and Key Program Elements

Cynthia A. Challener, Ph.D.

Pharma's Almanac

Advanced PAT

Deeper Process Visibility: Advanced Monitoring Technologies for Modern Biologics Manufacturing

David Alvaro, Ph.D.

Pharma's Almanac

Aseptic Training

Human Factors in Aseptic Processing: Training, Behavior, and Risk Reduction

David Alvaro, Ph.D.

Pharma's Almanac

CCS

RABS or Isolators? Aligning Barrier Technology With Your Contamination Control Strategy

David Alvaro, Ph.D.

Pharma's Almanac

Autologous

A Release-by-Exception Model for Cell Therapy Quality Decisions

David Alvaro, Ph.D.

Pharma's Almanac

CGT Comparability

When Process Defines the Product: Managing Comparability in Cell and Gene Therapy Manufacturing

David Alvaro, Ph.D.; April Stanley, MS MBA

Pharma's Almanac

RTRT

Real-Time Release Testing: The Next Leap in Pharmaceutical Manufacturing

Charlotte Hughes, Ph.D.

Hamilton Company

Container Closure

From Afterthought to Attribute: How Container–Closure Integrity Is Engineered, Measured, and Maintained

David Alvaro, Ph.D.

Pharma's Almanac

CCi

Packaging as a Quality Attribute: Why Container–Closure Systems Are No Longer an Afterthought

David Alvaro, Ph.D.

Pharma's Almanac

CDMO Excellence

Delivering CDMO Excellence, Quality, and Value through Dedication

Adriana Kiędzierska–Mencfeld, Ph.D.

Rezon Bio

CDMO

Efficiency by Design: Meeting the Evolving Challenges of a Maturing Global Biologics Market

Felix Faupel

Rezon Bio

Mass Spectrometry

Growing Importance of Mass Spectrometry from Drug Discovery through Commercialization and Life Cycle Management

Stefan Lehnert, Ph.D.; Carsten Kroeger, Dr. rer. nat.

Coriolis Pharma

CRO

Right-Sized CRO Support for Right-Sized Sponsors

Alexander Fetkovsky; Roman Hrynchuk

SanaClis

APM

Raising the Bar in Analytical Excellence: Samsung Biologics’ Approach to Assay Performance Monitoring

Jinwon Choi, Ph.D.; Siyoong Seo; Masany Jung; Soeun Jang

Samsung Biologics

Quality

Building the Right Team and Resource Model to Support Quality System and Validation Activities

Verista

Biomanufacturing

Adaptive Biomaterials and the Future of Therapeutic Production

David Alvaro, Ph.D.

Pharma's Almanac

AVI

Advancing Drug Product Quality Through Automated Visual Inspection and Future-Ready Infrastructure

Mitsutaka Shirasaki

Samsung Biologics

Analytical

Compressing Analytical Timelines Without Cutting Corners

George Wei

Experic

Marketing

What Biotech and Pharma Buyers Actually Care About and How to Market Accordingly

Emilee Kudla

Pharma's Almanac

Analytical

Leveraging Advanced GMP Release and Stability Testing Methods to Accelerate New Drug Development

Gerhard Sax, Dr. rer. nat.; Carsten Kroeger, Dr. rer. nat.

Coriolis Pharma