gmp-manufacturing
(7)
Made Scientific
Made Scientific is a Princeton, New Jersey-based contract development and manufacturing organization (CDMO) focused exclusively on cell therapies. Formerly BioCentriq, it was rebranded in March 2025 and is backed by South Korea's GC Corporation. The company runs a 60,000 sq. ft. GMP facility with five ISO 7 / Grade B cleanrooms, offering process and analytical development, GMP manufacturing of autologous and allogeneic products, aseptic fill and finish, QC release testing, regulatory consulting, and workforce training, taking cell therapy programs from preclinical development through commercial supply.
Krystal Biotech, Inc.
Krystal Biotech is a Pittsburgh-based commercial-stage biotechnology company that pioneered redosable, off-the-shelf gene therapy delivered directly to the body. Its lead product VYJUVEK became the first FDA-approved topical and redosable gene therapy in 2023, treating the rare skin disease dystrophic epidermolysis bullosa. Built on a proprietary HSV-1 vector platform (STAR-D), the company runs its own GMP manufacturing and is extending the same delivery technology into respiratory disease, oncology, ophthalmology and aesthetics.
I Peace, Inc.
I Peace, Inc. is a Palo Alto- and Kyoto-based biotech that mass-manufactures clinical-grade induced pluripotent stem cells (iPSCs) using a proprietary automated, closed-cassette platform. Founded in 2015 by Koji Tanabe - a co-author of the world's first human iPSC paper from Shinya Yamanaka's Nobel Prize-winning lab - the company operates as a CDMO supplying GMP-grade iPSCs to pharmaceutical companies, biotechs, and research institutions, and offers personal iPSC banking and longevity services that aim to make cell therapy affordable and accessible.
Kriya Therapeutics, Inc.
Kriya Therapeutics is a clinical-stage biopharmaceutical company building one-time, AAV-based gene therapies for prevalent chronic diseases of high unmet need. Founded in 2019 and headquartered in Morrisville, North Carolina with operations in Silicon Valley, Kriya pairs a proprietary, vertically integrated manufacturing and R&D engine with a pipeline spanning ophthalmology, metabolic disease, and neurology. Its bet: gene therapy shouldn't be reserved for the rare few, but engineered and manufactured at the scale and cost needed to reach millions.
Kytopen
Kytopen is a Cambridge, Massachusetts biotech and MIT spinout building Flowfect, a non-viral, continuous-flow platform that uses fluid flow plus electric fields to deliver mRNA, DNA and CRISPR payloads into cells. The technology aims to engineer hundreds of billions of cells in minutes, removing a major bottleneck in discovering, developing and manufacturing advanced cell therapies like CAR-T and NK-cell treatments.
Terran Biosciences
Terran Biosciences is a platform biotech developing therapeutics and technologies for neurological and psychiatric disease. It runs one of the industry's largest psychedelic development programs - psilocybin, LSD, MDMA derivatives and novel prodrugs - alongside late-stage schizophrenia assets licensed from Sanofi and Pierre Fabre, GMP psychedelic manufacturing, and NM-101, an FDA-cleared cloud platform for neuromelanin MRI analysis.
BreezeBio
BreezeBio (formerly GenEdit) is a Brisbane, California-based biotechnology company that develops precision genetic medicines using its proprietary NanoGalaxy platform - a library of polymer nanoparticles capable of delivering genetic payloads like mRNA, siRNA, and CRISPR components to specific tissues without triggering immune responses. Unlike viral vectors that can only be dosed once and often provoke dangerous immune reactions, BreezeBio's non-viral approach allows repeat dosing, broad payload flexibility, and tissue selectivity across immune cells, heart, lung, and CNS. Founded in 2016 out of UC Berkeley by CEO Dr. Kunwoo Lee and CTO Dr. Hyo Min Park, the company rebranded from GenEdit in early 2026 following its $60M Series B, signaling a shift from delivery-platform licensor to full therapeutic developer with a lead program (BRZ-101) targeting Type 1 Diabetes.