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To meet your program goals, we develop novel and improve existing synthetic routes for complex chemicals, cytotoxins, payloads, linkers, HPAPI, biopolymers, and nanoparticles. We design, evaluate, and execute state-of-the-art synthetic strategies to deliver quality molecules with chiral integrity.
We offer product development and formulation programs to accelerate your timelines by leveraging our comprehensive in-house capabilities, technologies, and knowledge to deliver processes tailored to your molecule of interest.
We ensure the purity and integrity of your products by offering an extensive range of capabilities in the Analytical Method Development (AMD) and QC departments.
We utilize quality by design (QbD) principles and follow ICH Product Lifecycle guidelines to develop 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.
To meet your program goals, we design novel and improve existing synthetic routes for complex chemicals, cytotoxins, payloads, linkers, HPAPI, and biopolymers.
By proposing and executing more efficient and innovative approaches we achieve optimized timelines which enable you to file your market application sooner.
We design, evaluate, and execute state-of-the-art synthetic strategies to deliver quality molecules with chiral integrity.
Capabilities include:
With extensive experience in the synthesis of synthetic polymers and conjugation, our scientists design, deliver and test polymer-based nanoparticles for your program needs.
These polymers can then be conjugated with small molecules and proteins resulting in the formation of well-defined nanoparticles used for various therapeutic applications.
To create a robust product development program and accelerate your timelines we leverage our comprehensive in-house capabilities, technologies, and knowledge to deliver analytical 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.
To ensure the purity and integrity of your products Abzena offers an extensive range of capabilities in the Analytical Method Development (AMD) and QC departments, enabling the development of verified analytical methods and stringent in-process controls.
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 molecules, peptides, and proteins.
We develop the most effective processes for manufacturing at toxicology, clinical, and commercial scale using quality by design (QbD) principles.
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.
We adapt our approach to shorten lead times and develop risk mitigation strategies to ensure your overall success in delivering vital medicines to patients.