AGC Biologics S.p.A.
AGC Biologics is a global Contract Development and Manufacturing Organization (CDMO) providing development and manufacturing services for biologics and advanced therapies. With a mission to improve patients' lives by bringing new biopharmaceuticals to market, they operate a worldwide network of facilities and are committed to innovation, quality, and customer partnership. They support a wide range of modalities including mammalian and microbial-based proteins, mRNA, plasmid DNA, viral vectors, and cell therapies, offering services from early development to full-scale commercialization.
Industries
Nr. of Employees
Very Large (1000+)
AGC Biologics S.p.A.
Patents
Products
Pre-qualified viral vector manufacturing platforms
Templated manufacturing platforms for lentiviral and AAV production that standardize unit operations to reduce time-to-GMP and simplify scale-up.
GMP cold storage and validated warehouse capacity
Validated GMP cold-chain storage including ultra-low temperature freezers and integrated warehouse management for storage of APIs and clinical materials.
End-to-end ADC development program
Program-level integration of antibody generation, conjugation and payload workflows to support ADC development from concept through manufacturing.
Pre-qualified viral vector manufacturing platforms
Templated manufacturing platforms for lentiviral and AAV production that standardize unit operations to reduce time-to-GMP and simplify scale-up.
GMP cold storage and validated warehouse capacity
Validated GMP cold-chain storage including ultra-low temperature freezers and integrated warehouse management for storage of APIs and clinical materials.
End-to-end ADC development program
Program-level integration of antibody generation, conjugation and payload workflows to support ADC development from concept through manufacturing.
Services
Transfer of developmental processes into GMP manufacturing including technical documentation, scale-up execution and manufacturing readiness activities.
Scale-up and characterization of upstream fermentation and downstream purification processes to establish scalable, robust manufacturing workflows.
End-to-end cell line development including transfection, clone selection, RCB/MCB generation and stability studies, using accelerated cloning and early-banking approaches to shorten timelines to MCB and drug-substance availability.
Analytical method development, formulation screening and release assay establishment to support identity, purity, potency and stability testing across development stages.
Validation planning and execution including process performance qualification and continued process verification strategies for late-phase and commercial programs.
GMP-compliant manufacturing across modalities and scales, including cell therapy and viral vector production with integrated downstream and fill/finish capabilities.
Transfer of developmental processes into GMP manufacturing including technical documentation, scale-up execution and manufacturing readiness activities.
Scale-up and characterization of upstream fermentation and downstream purification processes to establish scalable, robust manufacturing workflows.
End-to-end cell line development including transfection, clone selection, RCB/MCB generation and stability studies, using accelerated cloning and early-banking approaches to shorten timelines to MCB and drug-substance availability.
Analytical method development, formulation screening and release assay establishment to support identity, purity, potency and stability testing across development stages.
Validation planning and execution including process performance qualification and continued process verification strategies for late-phase and commercial programs.
GMP-compliant manufacturing across modalities and scales, including cell therapy and viral vector production with integrated downstream and fill/finish capabilities.
Expertise Areas
- cGMP manufacturing for biologics, cell and gene therapies
- Mammalian cell line development with accelerated timelines
- Microbial fermentation and inclusion body/refolding processing
- Viral vector process development and platform manufacturing
Key Technologies
- Single-use bioreactors
- Perfusion bioreactor systems
- Stainless-steel fermenters
- Large-volume protein refolding tanks
News & Updates
AGC Biologics accepted applications for tours of its Milan site on September 26, 2022, showcasing viral vector production and purification processes.
With a new expansion in Copenhagen, AGC Biologics more than doubles its mammalian biologics capacity using single-use bioreactor technology, supporting more projects and increasing flexibility.
Recognition for excellence in quality management systems and leadership in the biopharma industry.
AGC Biologics accepted applications for tours of its Milan site on September 26, 2022, showcasing viral vector production and purification processes.
With a new expansion in Copenhagen, AGC Biologics more than doubles its mammalian biologics capacity using single-use bioreactor technology, supporting more projects and increasing flexibility.
Recognition for excellence in quality management systems and leadership in the biopharma industry.