gmp-manufacturing
(10)
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.
Phillip Maderia
Phillip Maderia is the Chief Executive Officer of PranaX, a Houston-based regenerative-medicine biotech developing stem cell-derived exosome products at the Levit Green campus in the Texas Medical Center. He joined in March 2025 after four years running Lonza's exosome manufacturing site in Lexington, Massachusetts - the facility Lonza bought from Codiak BioSciences in 2021, where Maderia had previously served as VP of Manufacturing Operations. He is a career biomanufacturing operator with roots at Sanofi Genzyme and LFB-USA and roughly three decades of scale-up experience.
Syed T. Husain
Syed T. Husain is the Chairman and CEO of Made Scientific, a Princeton, New Jersey cell therapy contract development and manufacturing organization (CDMO) that he relaunched in 2025 out of the former BioCentriq. Backed by GC Corporation, the company runs a 60,000-square-foot GMP facility built to move autologous and allogeneic cell therapies from clinical batches to commercial supply. A chemical engineer by training who started on the manufacturing floor at Wyeth and Pfizer, Husain spent more than two decades in CDMO leadership at Lonza, Alcami, Emergent BioSolutions, and Resilience before taking the top job. He named the rebranded company MADE for Manufacturing and Development Excellence.
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.
Shankar Ramaswamy
Shankar Ramaswamy is the co-founder, chairman and CEO of Kriya Therapeutics, a clinical-stage biopharmaceutical company building one-time gene therapies for common, highly prevalent chronic diseases rather than only rare ones. A physician by training who started his career evaluating drug candidates at Roivant Sciences and helping launch Axovant's record biotech IPO, he founded Kriya in 2019 and has since raised more than $600 million to vertically integrate gene therapy design, computational biology and in-house GMP manufacturing.
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.