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Scientist filling containers inside ISO Class 5 environment provided by the Logic+ Class II, Type A2 Biosafety Cabinet.

Abzena – San Diego Lusk Facility

San Diego, CA |
  • Biopharma
  • Abzena San Diego Lusk Facility
  • A look inside the cGMP manufacturing lab of the San Diego Lusk Facility.
  • Scientist working inside Labconco Class II, Type A2 Biosafety Cabinet inside the cGMP laboratory.
  • Scientist filling containers inside ISO Class 5 environment provided by the Logic+ Class II, Type A2 Biosafety Cabinet.

Speed to market is critical to the development of advanced medicines. As a large biopharma contract development and manufacturing organization (CDMO), Abzena drives the discovery and manufacturing of complex biologics and bioconjugates for its clients around the globe.

 

Challenges

Abzena’s rapid growth presented an urgent need to evolve into a fully integrated end-to-end biotherapeutic and antibody-drug conjugate (ADC) powerhouse. As a full-service provider of cGMP biotherapeutics, Abzena required equipment designed to support advanced therapies. They needed to sustain an accelerated pace without compromising on precision, quality or safety.

Solutions

Abzena developed five state-of-the-art facilities across North America and Europe outfitted with critical equipment to support the development and manufacture of advanced therapies with rapid speed. The San Diego Lusk Facility has 20,800 square feet of dedicated manufacturing space, including a quality control microbiology laboratory, a quality control analytical laboratory, stability chamber and staging warehouse space. This facility focuses on biologics drug substance development and manufacturing.

To support the 15,800 square feet of cGMP manufacturing space, Abzena integrated Labconco’s Logic®+ Class II, Type A2 Biosafety Cabinets (BSCs) into several key processes within the facility, including master cell bank preparation and inoculum preparation (initial thaw and expansion (ITE)). Labconco’s BSCs are engineered to operate within ISO 5 aseptic working conditions, providing superior user protection when working with biological materials. Logic+ BSCs offer controlled airflow, enhanced filter life and ergonomic considerations to maintain safety conditions crucial for sensitive processes.

Benefits

The expansion project has enabled Abzena to bolster its capabilities in biologics development and manufacturing, enhancing its ability to meet the growing demand for biopharmaceutical products. By incorporating Labconco’s Class II BSCs, Abzena can ensure the integrity and sterility of each biotherapeutic throughout the development process to deliver life-altering treatments with unprecedented speed and reliability.

Check out this video walk-through of the San Diego Lusk Facility here.

Facility At-A-Glance

Biologics Drug Substance Development and Clinical & Commercial Scale Manufacturing 

  • Comprehensive biologic process development for therapeutic proteins and recombinant vaccines, including antibodies, bispecifics and bifunctional immunotherapeutics
  • Robust analytical method development portfolio
  • MCB/WCB cGMP suite (Class 10,000) with ISO Class 5 (Class 100) BSCs
  • ISO Class 8 cGMP suites (class 100,000) - 50L, 200L, 500L, to 2000L
  • Biologic Quality Control Stability

Learn more about Abzena by visiting Abzena.com.