07.07.26 -- A New Framework For CDMO Quality Oversight — And What It Changes

The goal is practical: help development teams make early decisions that balance speed, quality, and risk and support a smoother path to the clinic.

The complex biology of rare diseases creates unique hurdles, making it difficult to design and implement a drug development program. Explore the unique considerations for drug product manufacturing.

How strategic investments in development, manufacturing, and clinical supply are helping organizations reduce risk and accelerate drug development.

Automated optical inspection enhances injectable quality by improving detection accuracy, ensuring consistency, and enabling high-speed defect and container integrity checks.

Discover how safety‑by‑design principles in chemical synthesis help control exothermic reactions, reduce scale‑up risk, and enable safer, more reliable manufacturing of complex drug substances.

See the demonstration of precise, site‑specific integration of a 50 kb multi‑gene construct into human iPSCs, overcoming size limits of traditional genome‑engineering approaches.

Antibody–drug conjugates link antibodies to potent toxins, but increased hydrophobicity impairs stability, manufacturing, and PK, spurring interest in hydrophilic linker strategies.

Viral clearance studies face regulatory uncertainty, process limits, timeline pressure, and design challenges, demanding phase‑appropriate, flexible strategies for reliable outcomes.

Nose‑to‑brain delivery enables targeted neurological treatment by using direct neural pathways to boost precision and limit systemic exposure, with new formulations and devices driving rapid progress.

Examine an outline of antibody-oligonucleotide conjugate manufacturing: process development, scale-up, GMP production, and analytical controls for efficient early-phase clinical material generation

Explore how an innovative platform, powered by Selexis®, accelerates the development of complex biologics from early stages to first-in-human (FIH) trials, focusing on both speed and quality.

Review the pros and cons of soluble and insoluble processes, experiences with isolating, solubilizing, and properly re-folding, and strategies and innovation to improve insoluble processes.