Preclinical/ IND & CTA Enabling

Fully Integrated, Seamless Solutions

We accelerate the development of your medicines, de-risk your program and reduce time to market by leveraging the broad experience of our scientists. Supporting our partners, we design, synthesize, and manufacture payloads and payload-linker constructs for ADC and bioconjugation.

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

Leveraging our experience in the synthesis of payloads, linkers, and payload-linker chemical intermediate constructs we enable 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.

Linker Payloads

Ensuring the manufacturability and reliability of your most complex materials, we efficiently bridge early phase development into manufacturing.

We customize your program using extensive experience in the standard approaches for linker-payloads as well as expertise and access to next-generation technologies and novel approaches.

This enables us to be at the forefront of innovation and the evolution of bioconjugation technologies.

Bioconjugates and ADCs

In collaboration with your team, Abzena’s bioconjugation group designs and builds an efficient program that de-risks development and accelerates the timeline for your ADC program.

Our integrated approach gives immediate access to cross functional expertise and the ability to combine information and insight to manage your program more effectively, troubleshoot issues and inform the best process.

We can manufacture fully characterized ADCs with all known cytotoxins, release mechanisms and polymers, and a broad range of conjugation technologies.

Analytical Method Development

Your product development program will be accelerated by leveraging our extensive in-house capabilities, technologies, and knowledge to deliver methods tailored to your molecule of interest.

Methods are evaluated and documented in a phase appropriate manner and utilized to support process characterization along with drug substance release and stability testing.

Formulation Development

With a focus on aligning your drug candidates to the ideal target product profile (TPP) we develop a comprehensive range of formulation development packages.

These include stable liquid and lyophilized formulations for small and large therapeutic molecules such as peptides, proteins, monoclonal antibodies and antibody-drug conjugates (ADCs).

Process Development

We develop the most effective processes for manufacturing at toxicology, clinical, and commercial scale.

Our knowledge of cGMP manufacturing enables us to successfully transfer existing processes into our facilities or develop a new innovative process, when needed, to meet your program needs.

Processes follow ICH Product Lifecycle guidelines which ensure a robust and well characterized scalable manufacturing process. Utilizing analytics, we ensure the right product quality attributes for your program.

Work with us

We adapt our approach to shorten lead times and develop risk mitigation strategies to ensure your overall success in delivering vital medicines to patients safely and quickly.