Quality is Everything

Development CDMO

The Case for Earlier CDMO Involvement in Drug Development

David Alvaro, Ph.D.

Pharma's Almanac

Biologics

Commercial Thinking Begins in Clinical Phases

Mathias Kahl

IDT Biologika

Lipase Risk

An Integrated Analytical Approach to Lipase Risk Management in Biologics Development

Kyeyeon Hur, Ph.D.; Jimin Kim, Ph.D.; Minjeong Lee; Soojeong Oh; Woojung Jun

Samsung Biologics

Pathfinder

Digital Twins vs. Traditional Scale-Up Models: Which Approach Is Better for Bioprocess Development?

Nice Insight

Potency Assurance

Why Potency Cannot Be Reduced to a Release Assay in Active Immunotherapy Development

David Alvaro, Ph.D.

Pharma's Almanac

Data Integrity

Data Integrity: Drivers, Challenges, and Key Program Elements

Cynthia A. Challener, Ph.D.

Pharma's Almanac

LNP Strategy

Building Better RNA Medicines Through Smarter LNP Formulation Strategy

Aula Al Muslim, Ph.D.

Recipharm Advanced Bio

Oligo Analytics

Impurities, Sequence Fidelity, and Structural Variants in Nucleic Acid Therapeutics

David Alvaro, Ph.D.

Pharma's Almanac

Pathfinder

In Vitro vs. In Vivo Potency Assays: Which Approach Is Best for Biopharmaceutical Product Characterization?

Nice Insight

PAT

Real-Time Insight in Biologic Manufacturing: Why PAT Matters for Commercial Scale-Up

David Alvaro, Ph.D.

Pharma's Almanac

PAT

From Analytical Visibility to Real-Time Control in Biologics Purification

David Alvaro, Ph.D.

Pharma's Almanac

Advanced PAT

Deeper Process Visibility: Advanced Monitoring Technologies for Modern Biologics Manufacturing

David Alvaro, Ph.D.

Pharma's Almanac