CDMO Capabilities
CDMO Capabilities
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Cell Line Development & Platform Technologies (iPSCs):
Cell Line Development & Platform Technologies (iPSCs):
Readily available, immune-cloaked iPSC master cell lines derived from primary CD34 or CD4+ T-cells, ready for immediate use
Cell lines are manufactured under GMP using proprietary IP in regenerative medicine, immune-evasive CAR-T and NK cell therapies, and tissue engineering
Proprietary gene-editing CRISPR technology that delivers multiple gene edits in a single round and reliable delivery of large genetic payloads
Innovative Co-Development model for creating new allogeneic, cell therapy assets for your pipeline
GMP Manufacturing (iPSC to Drug Product) - Platform Technologies & CDMO Activities (iPSCs):
GMP Manufacturing (iPSC to Drug Product) - Platform Technologies & CDMO Activities (iPSCs):
Oncology
Oncology
High-yield platform for iPSC-NK manufacturing
Allogeneic T-cell therapies – including α/β T cells and Tregs
Differentiation and characterization of iPSC-Derived T cells
Regenerative Medicine
Regenerative Medicine
GMP manufacturing platform that delivers clinical grade, high-purity iPSC-derived cardiomyocytes
Pre-established iPSC-to-endothelial differentiation process with scalable GMP manufacturing and a complete CMC framework
Facilities
Facilities
GMP Facility with GMP bioreactors from 2L to 100L
9 GMP cleanrooms
5 Cell Line Development Suites
6 Process Development Labs
Drug Substance or Active Pharmaceutical Ingredient (API) Manufacturing - France & Germany
Drug Substance or Active Pharmaceutical Ingredient (API) Manufacturing - France & Germany
3 FDA Inspected facilities manufacturing clinical and commercial programs
Wide range of capabilities from Kgs to hundreds of tons
Reactors ranging from 10L to 10,000L
HPAPI Capability to handle OEB 4, 5 and 6 compounds
Dedicated equipment trains for steroids
Niche capability including sterile crystallization and spray drying
Process Development and Optimization for Scale up of Drug Substance
Oral Solid Dosage Development and Manufacturing
Oral Solid Dosage Development and Manufacturing
6 Manufacturing Sites - 4 FDA Approved
Formulation development: Tablets, Capsules, and Oral Solutions
Pilot and small-scale clinical and commercial batches
High potent and conventional tablets and capsules (OEB 1 -6)
Large scale commercial manufacturing sites – Billions tablets/capsules per year
Commercial Packaging - Bottles and Blisters
Sterile Drug Product Development and Manufacturing -
Sterile Drug Product Development and Manufacturing -
7 manufacturing sites – 6 FDA approved
7 manufacturing sites – 6 FDA approved
Modalities: Small Molecules, Biologics, Peptides, ADCs, mRNA, non-viral vaccines
Injectable Drug Products: Vials, PFS, APIJECT, Ampoules. Powder (lyophilized), Liquids, Suspension
Ophthalmic Dosage Forms: Solutions, Emulsions, Suspensions, Gels, Creams, Ointments. Blow Fill Seal, 3 Piece Bottles, Multidose Bottles, Sterile Tubes, Novelia: Preservative-Free, Multidose Dropper
Regulatory Starting Materials (RSMs) - India
Regulatory Starting Materials (RSMs) - India
2 Manufacturing Sites in India - RSMs for clinical and commercial programs
Capability from grams to kilograms to tons
Rapid initial scale up from medicinal chemistry route to first kilograms
Pharma Expanse commissioned an audit of the facility as part of the supplier qualification process
Medicinal Chemistry - India
Medicinal Chemistry - India
Lead optimization, synthesis of NCE’s, focused libraries, building blocks and lead compounds
Route scouting and synthesis of analogues
Synthesis of reference standards, metabolites, impurities, and stable labeled compounds
Process Development and Preclinical Manufacturing - India
Process Development and Preclinical Manufacturing - India
Optimization and scale-up of existing processes
Developing new scalable and economically viable processes
Preclinical (non-GMP) manufacturing of API, Intermediates and RSMs
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