Preclinical/IND &
CTA Enabling

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.

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.

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).

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.