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Capability

regulatory CMC

Suppliers
2
States & provinces
2
Countries
1

2 regulatory cmc suppliers across 2 states and provinces in 1 country. Profiles show capabilities, materials, certifications, and facility locations so you can compare shops and build a shortlist.

Suppliers

AKYSO THERAPEUTICS, LLC

SAINT PETERSBURG, FL

Akyso Therapeutics is a privately held biotechnology company that has been working in sustained release drug delivery since 2014. It develops the iSTEP platform, a bioabsorbable, subcutaneous, tunable, extended-release polymeric implant providing drug delivery for six to twelve months. Its lead product is the iSTEP-N naltrexone implant for opioid use disorder, with iSTEP-B (buprenorphine) and iSTEP-G (GLP-1) in development.

formulation research and developmentGMP process scale-uppolymer engineeringpreclinical and clinical developmentsubcutaneous implant development

Compiled from public sources

ELEVATEBIO IPSC, INC.

WALTHAM, MA

ElevateBio is an advanced therapies CDMO that partners with innovators to identify drug targets and manufacture clinical and commercial cell and gene therapy products. Its capabilities span discovery, gene editing design and optimization, process development, technology transfer, analytical development, next-generation sequencing, cGMP manufacturing, regulatory CMC, and quality, across modalities including cell therapies, viral vectors, mRNA therapeutics and vaccines, and gene editing.

analytical developmentautomationcGMP manufacturinggene editing design & optimizationgenerative AInext-generation sequencingprocess developmentqualitytechnology transfer

Compiled from public sources

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