VxP Pharma
US-based contract development and manufacturing organization (CDMO) providing development, cGMP/cGLP manufacturing, and preclinical safety services for small molecules and biologics. Capabilities include sterile injectable fill/finish, lyophilization, biologics upstream/downstream processing, viral vaccine and vector production, solid-state and preformulation chemistry, analytical and bioanalytical testing, and IND/NDA-enabling studies. Facilities support tox and clinical trial material production and have been audited by global regulatory agencies.
Industries
Nr. of Employees
small (1-50)
VxP Pharma
Indianapolis, Indiana, United States, North America
Products
Contract Development and Manufacturing Services (CDMO)
Provides contract development and manufacturing services for small molecule and biologics drug programs, including clinical and commercial production.
Preclinical Support Services
Provides comprehensive preclinical support for drug development programs including toxicology and formulation support.
Ophthalmic Manufacturing Services
Manufactures sterile ophthalmic products such as eye drops with controls to ensure sterility, safety, and product stability.
Contract Development and Manufacturing Services (CDMO)
Provides contract development and manufacturing services for small molecule and biologics drug programs, including clinical and commercial production.
Preclinical Support Services
Provides comprehensive preclinical support for drug development programs including toxicology and formulation support.
Ophthalmic Manufacturing Services
Manufactures sterile ophthalmic products such as eye drops with controls to ensure sterility, safety, and product stability.
Services
CDMO manufacturing for sterile and lyophilized products
cGMP development and manufacture of sterile vials, pre-filled syringes and lyophilized drug products for toxicology, clinical and niche commercial supply.
Biologic and viral vector development and GMP manufacturing
Process development and GMP manufacture of viral vaccines, viral vectors and other biologics, including upstream and downstream processing and production of master/working cell and virus banks.
Preclinical safety and toxicology studies
In vivo and in vitro toxicology, DMPK/ADME, biomarker and pathology services to support IND/NDA enabling studies under cGLP and GLP-like programs.
Preformulation and solid-state chemistry services
Solid-state and solution stability testing, polymorph and salt screening, solubility profiling, and early tox formulation development to support reproducible API supply and formulation selection.
Lyophilization cycle development and pilot scale-up
Low-temperature thermal analysis, cycle design/refinement and pilot plant scale-up to support transition from concept to clinic.
CDMO manufacturing for sterile and lyophilized products
cGMP development and manufacture of sterile vials, pre-filled syringes and lyophilized drug products for toxicology, clinical and niche commercial supply.
Biologic and viral vector development and GMP manufacturing
Process development and GMP manufacture of viral vaccines, viral vectors and other biologics, including upstream and downstream processing and production of master/working cell and virus banks.
Preclinical safety and toxicology studies
In vivo and in vitro toxicology, DMPK/ADME, biomarker and pathology services to support IND/NDA enabling studies under cGLP and GLP-like programs.
Preformulation and solid-state chemistry services
Solid-state and solution stability testing, polymorph and salt screening, solubility profiling, and early tox formulation development to support reproducible API supply and formulation selection.
Lyophilization cycle development and pilot scale-up
Low-temperature thermal analysis, cycle design/refinement and pilot plant scale-up to support transition from concept to clinic.
Expertise Areas
- Contract development and manufacturing (CDMO) for sterile and non-sterile products
- Biologics and viral vector vaccine process development and manufacturing
- Preclinical safety, toxicology and IND/NDA-enabling studies
- Lyophilization and low-temperature product development
Key Technologies
- Lyophilization (freeze-drying)
- Aseptic fill/finish systems (isolators, RABS, mono-block automation)
- Single-use bioreactor systems
- Mammalian cell culture and viral vector production