Newsletter | July 2, 2026

07.02.26 -- EMA's New Guideline For Synthetic Peptides: A More Explicit CMC Playbook For A Growing Therapeutic Class

INDUSTRY INSIGHTS

Should Platform Companies Partner, Sell, Or License Their Technology?

Platform biotech companies face critical choices on partnering, licensing, or selling technology—decisions that shape focus, valuation, and long‑term success beyond scientific innovation alone.

How Digital Procedures And eLogbooks Are Transforming Manufacturing

Paper-based records still shape many life sciences operations, but they bring hidden risks. Gain insight into how manual documentation impacts accuracy, efficiency, and compliance.

Data-Driven Strategies To De-Risk OSD Development

Watch as Quentin Horgan, Director of Drugs Intelligence at GlobalData discusses how early-stage insights can improve development outcomes and reduce downstream risk.

FEATURED EDITORIAL

EMA's New Guideline For Synthetic Peptides: A More Explicit CMC Playbook For A Growing Therapeutic Class

The European Medicines Agency’s Guideline on the Development and Manufacture of Synthetic Peptides, adopted in Dec. 2025 and effective from June 1, 2026, is an important regulatory development for peptide manufacturers.

INDUSTRY INSIGHTS CONTINUED

Navigating Drug Development Challenges With Lipid-Based Formulations

Maximize the oral bioavailability of challenging small-molecule candidates and streamline the path from preclinical toxicology to clinical trials by leveraging optimized lipid-based formulations.

T3P – A Green Solution For Peptide Coupling, Water Removal Reactions

The session focuses on the use of T3P (propanephosphonic acid anhydride) in amidation and peptide coupling reactions, including both liquid-phase and solid-phase peptide synthesis.

Utilizing Small-Scale Downstream Studies Across Biologics Manufacturing

Small-scale downstream studies play a critical role in enabling efficient, low-risk tech transfer for biologics development.

How To Mitigate Particulate Contamination In cGMP

Maintaining cGMP standards, controlling particulate contamination ensures drug safety, quality, effectiveness, and shelf life while preventing immune reactions and regulatory noncompliance.

Catalytic Flow Process Applications In The Pharmaceutical Industry

Harness the power of catalytic continuous flow reactions to achieve safer, greener, and more efficient chemical manufacturing with enhanced scalability and product quality.

Applying Automation To The Manufacture Of Drug Delivery Devices

Automated manufacturing is a powerful but often misunderstood tool available to produce drug delivery and other pharmaceutical devices — whether established designs or innovative new ideas.

Fast-Track Innovation, Address CMC Challenges In Expedited Pathways

Overcome solubility challenges and utilize flexible development strategies to transition innovative treatments from early-phase trials to commercialization while ensuring patient safety.

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