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

Potency Assurance

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

David Alvaro, 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

ADCs

Accelerating ADC Analytical Method Development Through Platform Innovation

Jaeook Kim, Ph.D.

Samsung Biologics

Biosimilars

Biosimilars at a Crossroads: Will the FDA’s New Framework Deliver Competition?

David Alvaro, Ph.D.

Pharma's Almanac

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

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

Analytical

Compressing Analytical Timelines Without Cutting Corners

George Wei

Experic

Formulation

Formulation and Analytics Platforms Transforming Drug Product Development

David Alvaro, Ph.D.

Pharma's Almanac

Automation

Engineering the Future of Biopharmaceutical Manufacturing with Intelligent Automation and Digitalization

Eckelmann Group

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

Fermentation

Achieving Scalable and Sustainable Precision Fermentation Using Process Analytical Technology

Charlotte Hughes, Ph.D.

Hamilton Company

RNA

Optimized Residual dsRNA Detection for mRNA Therapeutics

Namhyun Kim; Hwanjun Yoon, Ph.D.; Sukhwan Kim; Ahyeon Hwang; Eunseo (Ency) Lee, Ph.D

Samsung Biologics

Bioassays

Developing a Toolbox of Functional Bioassays for Optimizing ADCC

Anke Hartung, Ph.D.,

Tanvex CDMO