Welcome to Abzena San Diego
➔ cGMP manufacturing to support all stages of clinical development thru commercial
➔ Expertise in regulatory and quality processes
➔ Process development and analytical capabilities to streamline development and manufacturing
➔ Mammalian cell types include: CHO, NSO, SP2, YP2, and PER.C6
➔ Molecule types supported: Monoclonal Antibodies (mAbs), Fragment Antibodies (Fabs), Antibody-Drug Conjugates (ADCs), Bispecifics, Fusion Proteins, Bioconjugates, Duobodies, Recombinant Vaccines, and Nanoparticles
Process Development Capabilities
Our process development capabilities are spread across 6,600 sqft of laboratory space, enabling seamless and successful scale-up from bench to GMP manufacture, and includes comprehensive support at all stages of development for a variety of molecules expressed from multiple mammalian cell types.
Analytical Method Development
Our knowledgeable and dedicated team of scientists develop analytical test methods and qualification protocols to ensure the production of high-quality, and well-characterized material, in order to generate the data needed to support successful IND, IMPD and marketing applications.
cGMP Clinical & Commercial Manufacturing
The state-of-the-art, built-for-purpose, GMP manufacturing facility has the production capacity to scale your program from 50L to 2000 L. Using the same equipment families from bench processes, and leveraging single-use technologies, we can ensure an expedited path to the clinic.
Key manufacturing features:
Release Testing & CoA Generation
QC analytical and microbiology laboratories are fully equipped to provide the comprehensive QC support needed to safeguard your program including release testing, Certificate of Analysis Generation, stability program management and raw material and in-process testing.
Supply Chain Management
Our 22,000 sq ft GMP warehouse has 3 walk-in freezers and a continuous temperature monitoring system to ensure your product is appropriately stored. Each package is inventoried using our electronic inventory management system, where raw materials are quarantined, released, and stored at their necessary requirements.
When it comes time to transfer your program to a downstream supply chain partner, our program managers work as an extension of your team to ensure on-time delivery, so that your project timelines and goals are always met.
San Diego Locations
