Advanced Therapies CDMO: Manufacturing Advanced Therapies To Reach More Patients

Cell and gene therapy science has advanced quickly, but manufacturing economics haven't kept pace. This advanced therapies CDMO aims to change that through sustained investment in automation, digital systems, and process standardization. Citing the ARM Advanced Manufacturing Whitepaper, it notes that autologous CAR-T batches cost an estimated $100K–$290K today, and projects that automation could bring this below $40K.

The approach treats technology investment as a permanent operating principle. Partners choose how far to adopt new tools, while the CDMO ensures the options exist. Examples include a partnership with Sartorius on the Eveo Cell Therapy Platform to increase CAR-T scale and throughput, and fully integrated electronic batch records, MES, and LIMS that give partners real-time visibility into product disposition.

Programs are designed for commercial scale from day one and can stay within one facility network from IND through BLA filing and commercial supply. Process development, manufacturing, analytics, and quality operate as one team, building quality into the process from the start. In 2025, the CDMO reported a 98%+ batch success rate, 10 tech transfers completed or initiated, and 40+ in-house QC release methods. Its modalities span CAR-T/TCR-T, allogeneic cell therapy, lentiviral vector, AAV, mRNA, engineered T and B cells, HSC/iPSC, and in vivo gene therapy.

The flagship 140,000 sq ft Waltham, Massachusetts facility is ICMC™ certified. A 125,000 sq ft Pittsburgh facility at Hazelwood Green, built with modular, automation-ready suites and a digital backbone, expects its first GMP batches in 2027.