Resilience
Contract development and manufacturing organization (CDMO) providing end-to-end development and GMP manufacturing for biologics, vaccines, gene and cell therapies. Services include process & analytical development, cell line and master cell bank support, viral vector and cell therapy manufacturing, aseptic fill/finish, tech transfer and scale-up, and integrated testing and data platforms across a network of North American facilities.
Industries
Nr. of Employees
Very Large (1000+)
Resilience
La Jolla, California, United States, North America
Products
Alachua, FL biomanufacturing campus (Building G)
BSL-2 manufacturing and process/analytical development campus with approximately 92,000 sq ft single-use manufacturing space, dedicated utilities, EU grades A–D particulate controls, multiple GMP suites and cold/ultra-cold storage.
Boston process & analytical development and manufacturing facility
Commercially licensed PAD center combining process and analytical development with 10 × 2,000 L drug substance manufacturing capacity for biologics, vaccines, nucleic acids and gene therapy.
Alachua, FL biomanufacturing campus (Building G)
BSL-2 manufacturing and process/analytical development campus with approximately 92,000 sq ft single-use manufacturing space, dedicated utilities, EU grades A–D particulate controls, multiple GMP suites and cold/ultra-cold storage.
Boston process & analytical development and manufacturing facility
Commercially licensed PAD center combining process and analytical development with 10 × 2,000 L drug substance manufacturing capacity for biologics, vaccines, nucleic acids and gene therapy.
Services
Short-cycle autologous CAR‑T manufacturing
Accelerated autologous CAR‑T manufacturing workflow designed to reduce manufacturing duration (example 3-day process) to enable faster clinical access and potential potency improvements.
Platform-based viral vector manufacturing
Scalable viral vector manufacturing service for AAV and lentiviral vectors with reserved GMP batches and accelerated process deployment for clinical trials.
End-to-end biologics process & analytical development
Integrated services covering cell line development, formulation, process development, analytical method development, and early clinical manufacturing to accelerate IND-enabling timelines.
Cell therapy characterization and QC (multi-omics & NGS)
High-dimensional multi-omics and single-cell genomics characterization and QC services to support cell therapy release testing, comparability and process optimization.
Platform-based autologous T-cell manufacturing (platformized cell therapy)
End-to-end manufacturing and assay platform for lentiviral-vector-based autologous T-cell therapies providing standardized unit operations, in-house release testing, digital batch records and regulatory support to accelerate clinical readiness.
Aseptic fill/finish and sterile drug product services
Aseptic fill/finish, formulation and packaging services with automated isolator-based filling for vials and syringes and supporting quality and regulatory requirements.
Short-cycle autologous CAR‑T manufacturing
Accelerated autologous CAR‑T manufacturing workflow designed to reduce manufacturing duration (example 3-day process) to enable faster clinical access and potential potency improvements.
Platform-based viral vector manufacturing
Scalable viral vector manufacturing service for AAV and lentiviral vectors with reserved GMP batches and accelerated process deployment for clinical trials.
End-to-end biologics process & analytical development
Integrated services covering cell line development, formulation, process development, analytical method development, and early clinical manufacturing to accelerate IND-enabling timelines.
Cell therapy characterization and QC (multi-omics & NGS)
High-dimensional multi-omics and single-cell genomics characterization and QC services to support cell therapy release testing, comparability and process optimization.
Platform-based autologous T-cell manufacturing (platformized cell therapy)
End-to-end manufacturing and assay platform for lentiviral-vector-based autologous T-cell therapies providing standardized unit operations, in-house release testing, digital batch records and regulatory support to accelerate clinical readiness.
Aseptic fill/finish and sterile drug product services
Aseptic fill/finish, formulation and packaging services with automated isolator-based filling for vials and syringes and supporting quality and regulatory requirements.
Expertise Areas
- Biologics process and analytical development (PAD)
- Viral vector (AAV/LVV) process development and manufacturing
- Cell therapy development and manufacturing
- Autologous CAR‑T manufacturing and short-cycle processes
Key Technologies
- Single-use bioreactors (500 L–2,000 L)
- Continuous/perfusion upstream and continuous downstream processing
- Closed automated manufacturing systems with in-line monitoring
- Aseptic isolator-based filling