Biologics

An increasing area of growth for the Pharmaceutical Industry is Biologics and Protein based treatments. A serious obstacle to evaluating Biologics is the need for ELISA assay development for detection.

ELISA can take up to 9 months to develop and suffer from cross-reactivity and matrix effects.

AMS SOLVES the Biologics problems. Through addition of a light, ¹⁴C tag using standard, well tested chemistries, quantitative human and animal pharmacokinetics are obtained in a matter of weeks from discovery.

Key Benefits are

• Speed - Weeks from Labeling to human PK data
• No matrix effects
• Absolute quantitation without ELISA development
• Inner core can be labeled and surfaces modification easily tested using the same core stock - optimize pegylation designs with speed and confidence
• Lowest Limits of Detection - Low femtoMolar levels easily accessible with high precision
• Can assess in vivo covalent binding to plasma proteins or tissue biopsies

Explore Pharmacokinetics and binding (PD) of modified antibodies or proteins without ELISA development. Under an exploratory IND, 30 nmoles can be administered with an extremely simple toxicology package.

Vitalea has specific experience in protein labeling and in vivo pharmacokinetics.