07.20.26 -- South Korea's Biotech Surge Builds On CDMO Strength

ADC lyophilization success depends on a tailored process using DSC and FDM to define critical stability parameters and support efficient manufacturing.

Adhering to the rigorous standards set by the EMA's Annex 1 requires strategic, risk-based compliance for facility design and processes, all of which is key to patient safety and future innovation.

Accelerate your path to clinic with a CDMO offering regulatory, clinical, and CMC expertise to advance your therapy and bring it closer to patients.

Common GMP pitfalls stem from poor scalability, late regulatory planning, weak tech transfer, unsuitable hosts, and inadequate quality systems, delaying biologics production timelines and budgets.

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

Maintain stability from fill to patient with temperature‑controlled storage, monitoring, and safeguards that protect quality, prevent degradation, and ensure cold chain integrity.

High‑concentration proteins improve convenience but risk viscosity, aggregation, and surfactant degradation—requiring innovative strategies to optimize stability, scalability, and quality.

Discover an autoinjector platform that supports ANDA pathways with demonstrated usability and design alignment to help development teams reduce risk and move confidently toward regulatory submission.

Whether you’re at the discovery stage or thinking about commercial production, gain useful insights on expression formats from transient transfection, through stable pools to stable clones.

Explore the benefits of prefilled syringes (PFS), the surge in demand driven by SARS‑CoV‑2, and why partnering with a flexible CDMO is key to successful drug delivery.

The initial 90 days of a fill/finish CDMO partnership establish lasting communication patterns, clarify mutual responsibilities, and test problem-solving capabilities critical to program success.

With a growing interest in developing new and improved bioconjugate drugs, explore an “innovation through collaboration” approach that can facilitate access to next-generation conjugation technologies.