Preclinical Biologics: IND & CTA Enabling

A Seamless Solution from Start to Finish

We accelerate the development of your medicines, de-risk your program and reduce time to market by leveraging the extensive experience of our scientists.

We design and deliver tailored solutions across a comprehensive suite of services including, cell line development, formulation, analytical method and process development.

Biologics discovery & development requires client-driven & flexible specialties companies

We provide our customers with a unique ecosystem of premium expert support through our DRIVE-Biologics collaboration with Oncodesign ServicesDRIVE-Biologics leverages the skills and expertise to develop antibodies in oncology and inflammation through a privileged collaboration that combines Abzena’s discovery, development, and manufacturing support of biologics and ADCs with Oncodesign Services of optimization to lead selection of naked or pay-loaded preclinical candidates vs TPP.

For more information about this streamlined collaboration, click here.

Cell Line Development (CLD)

Leveraging our wealth of experiences in biologic product development, Abzena generates cell lines with high productivity and the right product quality.

Timelines from DNA to Research Cell Bank (RCB) are accelerated through use of the latest technologies and robust workflows.

Our proprietary, license free CLD platform is fully integrated into the wider manufacturing process to accelerate timelines and de-risk development with the end goal in mind – safe, effective products.

Analytical Method Development

Your product development program will be accelerated by leveraging our expansive 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/ drug product 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.

Upstream and Downstream 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.