09.23.26 -- FDA Not A Good FRAME for CDMO Inspections?

Early choices affect manufacturing flexibility, tech transfer, and supply chain resilience. Addressing IP and production needs early helps preserve options for commercialization.

See how we enhance the bioavailability of poorly soluble drugs like Vemurafenib by producing dense amorphous dispersions, outperforming traditional MBP methods in pharmacokinetics and dissolution.

What if a formulation that removed the need for cold chain distribution was possible? Explore the formulation of vaccines and manufacturing considerations for dry powder inhaled vaccines.

Intravitreal injectables face some of the strictest regulatory scrutiny in drug development. Learn what sponsors need to know about EU GMP Annex 1, USP standards, and container closure integrity.

Driven by cut-throat domestic competition and a desire to diversify funding, developers are shifting from simple out-licensing deals toward sophisticated, long-term global capability building.

Tech transfer is inherently risky due to undocumented process nuances; partnering with a single-site U.S. CDMO minimizes complexity and preserves critical knowledge through commercialization.

Gain mechanistic insights beyond traditional viability assays, revealing nuanced cellular phenotypes and strengthening early drug discovery decisions without sacrificing throughput or efficiency.