Abzena

CHO cell line engineering and platform capabilities enhanced via partnerships to accelerate CLD efficiency and improve expression for complex biologics.

On-site biological testing laboratory providing analytical testing for biologic drug substance and drug product to support development and regulatory filings.

End-to-end antibody-drug conjugate development and manufacturing solutions designed to accelerate programs and de-risk the path to clinic and commercialization.

Tailored formulation development services for bioconjugates, including ADCs, AOCs, and RDCs, designed to optimize stability, support manufacturability, and accelerate progression from development to commercialization.

Commercial manufacturing services for bioconjugates, antibody-drug conjugates (ADCs), and antibody-oligonucleotide conjugates (AOCs) ensuring reliable supply, scalable production, and cGMP compliance.

Comprehensive bioconjugation technology transfer services ensuring seamless transition of manufacturing processes from development to commercial production.

Abzena accelerates HPAPI development and manufacturing with proven high-potency expertise, advanced containment technologies, and integrated chemistry-to-GMP capabilities, delivering scalable solutions for complex payloads, linkers, and bioconjugates.

Flexible highly potent API development and cGMP manufacturing services tailored to specific program needs under containment.

Comprehensive biologics development, process development, analytical testing, and cGMP manufacturing services provided at Abzena's San Diego facilities.

High-yielding cell line development (CLD) platforms for accelerating the generation of production cell lines for manufacture of antibodies and recombinant proteins.

A Glutamine Synthetase knockout CHOSOURCE CHO-K1 suspension cell line platform for enhanced development workflows.

In silico assessment tool for identifying immunogenic sequence hot spots in proteins.

A powerful tool for in silico immunogenicity assays and the design of deimmunized proteins and antibodies.

An innovative immunogenicity testing platform that utilizes flow cytometry technology for precise, multi-dimensional immunogenicity assays to de-risk vaccine development.

T cell epitope mapping service using proprietary assays to evaluate immunogenicity risks of protein therapeutics.

Dendritic cell and T cell assay for immunogenicity risk assessment and de-risking of biotherapeutics.

MHC Class II Associated Peptide Proteomics for the identification of immunogenic sequence hot spots and peptide presentation profiling.

Customized cytokine screening assay to evaluate safety and potential for cytokine release syndrome.

Comprehensive CDMO and CRO services providing fully integrated programs or individual tailored services spanning from early-stage research and discovery through commercial launch for complex biologics and bioconjugates.

Abzena's DNA-to-IND, CTA-enabling programs provide an integrated, accelerated pathway to take a molecule from DNA sequence to IND submission.

Integrated monoclonal antibody development and manufacturing solutions that reduce risk, accelerate timelines, and advance next-generation medicines from discovery through commercial supply.

Reliable, predictable, clinical through commercial cGMP bioconjugate manufacturing services for ADCs, AOCs, RDCs and more from Abzena.

End-to-end cGMP manufacturing platform for therapeutic biologics including monoclonal antibodies and recombinant proteins up to 2000 L scale.

End-to-end clinical through commercial cGMP biologics manufacturing services designed to de-risk the journey from clinical development to commercial supply for modalities such as ADCs, AOCs, RDCs, and Bispecifics.

Integrated CDMO and CRO services for the development, characterization, and GMP manufacturing of degrader-antibody conjugates (DACs), combining antibody targeting with targeted protein degradation payloads.

Stable pool expression service for larger-scale protein production up to 5-10g scale in as little as 8 weeks.

Seamless upstream and downstream biologics process development for complex therapeutics, combining advanced cell culture and purification techniques to deliver scalable solutions.

Integrated GMP drug substance manufacturing services designed to reduce commercialization risk, ensure scalable supply, and accelerate the delivery of high-quality medicines to patients.

An antibody-drug conjugation platform technology designed to overcome existing technology issues and provide improved stability, potency, and efficacy for ADCs.

Expert services for selecting, designing, synthesizing, and manufacturing optimal payload-linker constructs and antibody-drug conjugates (ADCs) to de-risk development and enhance therapeutic efficacy.

Research cell banking services designed to identify high-performing clones faster, improve product quality, and accelerate timelines from DNA to RCB in just 10 weeks.

Specialized development services for antibody-oligonucleotide conjugates (AOCs).

A collaborative, risk-based technology transfer and scale-up service that ensures manufacturing readiness, maintains product quality, and supports successful commercialization of biologics from clinical to commercial scale.

Specialized development services for radiolabeled and other novel bioconjugates.

An integrated IND-to-BLA development program designed to reduce late-stage risk, accelerate critical milestones, and support a seamless path to regulatory approval, commercialization, and biologics manufacturing.

cGMP commercial manufacturing services for mammalian-derived biopharmaceuticals.

Seamless upstream and downstream biologics process development, optimization and cGMP manufacturing from cell line development to patient.

Seamless upstream and downstream bioconjugate process development services for complex bioconjugates such as antibody-drug conjugates (ADCs), antibody-oligonucleotide conjugates (AOCs), and radionuclide drug conjugates (RDCs).

Comprehensive CDMO services for the design, engineering, expression, purification, characterization, and functional testing of bispecific and multispecific antibodies and T cell engagers.

Customizable cell-line suites and master cell banking services combining scientific excellence, regulatory rigor, and secure cryogenic storage.

Comprehensive suite of discovery services designed to de-risk biologic development and seamlessly bridge from discovery into preclinical development.

Comprehensive CDMO services for the design, development, and cGMP manufacturing of Radioconjugates, including Antibody-Chelate Conjugates (ACCs) for targeted radiotherapy and molecular imaging.

Comprehensive antibody discovery services tailored to client needs, providing expert assessments of target molecules, immunization strategies, and antibody screening cascades to select optimal candidates.

Comprehensive analytical method development and validation services to characterize bioconjugate products, supporting regulatory submissions and accelerating clinical progression.

Comprehensive bioassay and analytical solutions to streamline and de-risk complex biologic or bioconjugate development programs.

An advanced vector technology and genetic enhancement platform designed to significantly increase protein expression and yield in CHO cell lines for biopharmaceuticals and therapeutic proteins.

Tailored complex chemistry services covering the design and improvement of synthetic routes for complex chemicals, cytotoxins, payloads, HPAPIs, and fine chemicals to support bioconjugate and ADC development.

Preclinical development services spanning cell line development, process and analytical method development, formulation development, and clinical manufacturing.

Abzena’s Composite Human Antibody™ technology goes beyond traditional CDR grafting to deliver truly humanized antibodies that retain high affinity, exhibit robust manufacturability, and minimize unwanted responses.

Comprehensive analytical services supporting mammalian cell line development and biopharmaceutical manufacturing.

Abzena designs, executes, and documents phase-appropriate assays that are qualified or validated to ICH Q2(R1/R2) and ICH Q14, generating high-quality, well-characterized material and submission-ready data packages for FDA, EMA, and PMDA filings.

An optimized transient expression system that allows for the generation of up to ~500 mg of recombinant antibodies and rapid stage-appropriate material generation.

Synthesis of synthetic polymers and conjugation services including the design, delivery, and testing of polymer-based nanoparticles.

Stage-appropriate developability assessment solutions for complex biologics and bioconjugates designed to de-risk candidate selection and improve drug-like properties.

Specialized formulation development services for complex biological compounds, supporting biopharmaceutical products throughout their entire lifecycle from pre-formulation studies to clinical trials.

Hit screening, characterization, and hit selection platform using universal and pH-sensitive libraries to identify top lead candidates.

Comprehensive quality control and stability testing services designed to ensure product quality, support regulatory submissions, and accelerate clinical and commercial development for biopharmaceuticals.

GMP cell-based potency assays quantitively measure the biological activity of a biopharmaceutical drug for GMP product release and stability testing.

An analytical platform that combines predictive in-silico evaluation with laboratory methods to de-risk the application of platform analytical procedures and expedites the pathway to IND.

A deimmunization technology that designs safer and more effective therapeutic proteins, devoid of human T cell epitopes, to minimize potential immunogenicity in patients without compromising activity.