Abzena San Diego, USA

Welcome to Abzena San Diego

Abzena San Diego boasts a trio of cutting-edge facilities designed to accelerate the development, production, and testing of biologics.  From process development to analytics & bioassays,  and cGMP manufacturing, our experienced teams deliver high-quality programs that help our customers get life-changing medicines to patients faster.

Key Capabilities

➔ 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

Process Development Bioreactor



Process Development

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.

Upstream process development:

  • Tech Transfer
  • Process Verification
  • Process Optimization via DoE
  • Process Characterization
  • Parallel Bioreactor Systems at 250ml Scale

Downstream process development:

  • Harvest optimization:
    -Depth filtration
    -Continuous Centrifugation
  • Chromatography:
    -Hydrophobic Interaction
    -Metal Affinity
  • Column Chromatography:
    -1 ml thru 10L of bed volume
  • Filter Sizing Studies
  • Viral Filtration & Viral Clearance Validation
  • Process Intermediate Stability
  • Critical Quality Attributes (CQAs) & Critical Process Parameter (CPPs) Validation

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.

Comprehensive Analytical capabilities:

  • HPLC:
    -Size Exclusion, Reverse-Phase, Ion-Exchange, HILIC & HIC
  • HPLC Titer
  • ELISA & Cell-Based
  • Enzyme Activity Assays
  • Capillary Electrophoresis (CE-SDS & icIEF)
  • SDS-PAGE & Western Blot
  • SoloVPE & Other Protein Concentration Assays
  • HIAC
  • Compendial Assays
  • High-Res Mass Spectrometry (LC/Q-TOF)
  • In-Process Support & Release Testing
  • Non-GMP Stability & Forced Degradation

HPLCS at Sorrento Site


Analytical Laboratory

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:

  • ISO Class 5, 7, and 8 controlled environments with BSL-2 certification
  • Scale from 50L up to 2000L
  • Licensed by the California FDB and registered with the US FDA since 2005
  • Industry-leading Sartorius and Cytiva single-use technologies


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.

  • Content (Concentration by SoloVPE)
  • Potency (ELISA, inc. Cell Based ELISA)
  • Residual Impurities (HCP and Protein A ELISAs)
  • USP & EP Compliant Compendial Methods
  • Appearance, pH, Osmolality, endotoxin, bioburden


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

San Diego, CA, USA

6325 Lusk Blvd.
San Diego,
CA 92121

+1 858-550-4094

San Diego, CA, USA

2858 Loker Ave E. Suite 100
CA 92010

+1 858-550-4094

San Diego, CA, USA

11425 Sorrento Valley Rd.
San Diego,
CA 92121

+1 858-550-4094