Preclinical: IND/CTA Enabling

A seamless solution from start to finish.

Accelerating your drug into first-in-human trials in the USA and Europe requires the completion of an investigational new drug (IND) and clinical trial application (CTA), respectively. Both the FDA and EMA have different regulatory requirements, Abzena have the know how to help you meet this important milestone.

At Abzena, we offer fully integrated, seamless biologic preclinical solutions that accelerate the early development of your medicines trough to IND/CTA. We can de-risk your program and reduce time to market through leveraging the broad experience and scientific understanding.

Through our leading bioconjugation services, we design, synthesize, and manufacture payloads and payload-linker constructs for ADCs, AOCs and more.

We deliver tailored solutions for small molecule intermediates including high potency chemistry, payloads, linkers, payload-linker chemical intermediates, bioconjugation and antibody-drug conjugates (ADCs).

Preclinical IND & CTA Enabling Expertise

Preclinical activity is conducted through all phases of drug development. We recognize that this activity needs to be fully integrated into a regulatory-driven, collaborative drug development strategy. With over 20 years of experience in drug development, we offer specialized preclinical IND/CTA enabling services.

IND- and CTA-enabling studies comprise preclinical pharmacology and manufacturing studies. These allow you to submit a formal application with the FDA or EMA. We accelerate the development of your medicines, de-risk your program, and reduce time to market by leveraging the extensive experience of our scientific and regulatory affairs experts.

Linker Payload Design & Synthesis Expertise

Bioconjugates & ADCs - Abzena

Leverage our unique experience in the synthesis of payloads, linkers, and payload-linker chemical intermediate constructs. We enable the rapid generation of structure activity relationships (SAR) of various linker combinations with your new payloads. We identify the most suitable linker for your ADC profile aligned with your preferred design and for optimal stability and function.