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Read More Than Conjugation: ADC Manufacturing
Profile photo of Nicole Dale
Nicole Dale

More Than Conjugation: ADC Manufacturing

Pharmatica image of an ADC manufacturing facility showing antibody-drug conjugate drug product production and pharmaceutical processing equipment.

ADC manufacturing is becoming more complex as payloads, conjugation, lyophilisation, containment, and scale-up reshape CMC strategy and commercial readiness.

Biopharmaceutical Manufacturing
Read FDA Expedited IND Pilot Targets Faster First-In-Human Trials
Profile photo of Nicole Dale
Nicole Dale

FDA Expedited IND Pilot Targets Faster First-In-Human Trials

Pharmatica image showing planning for FDA Expedited IND Pilot application to support faster preparation for first-in-human clinical trials.

The FDA’s Expedited IND Pilot introduces rolling review and sponsor-QRI partnerships to accelerate Phase I first-in-human trials while retaining regulatory oversight.

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