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

manufacturing
pharmaceutical

Nr. of Employees

small (1-50)

VxP Pharma

Purdue Research Park, 5225 Exploration Drive, Indianapolis, IN 46241


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.


Services

cGMP development and manufacture of sterile vials, pre-filled syringes and lyophilized drug products for toxicology, clinical and niche commercial supply.

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.

In vivo and in vitro toxicology, DMPK/ADME, biomarker and pathology services to support IND/NDA enabling studies under cGLP and GLP-like programs.

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.

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
  • Show More (4)

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
  • Show More (6)

News & Updates

Article discussing upstream and downstream bioprocess optimizations to increase yields and lower costs for biologics manufacturing.

Overview of key considerations for aseptic filling lines, sterile material sterilization methods, and isolator vs RABS operations.

Discussion of preformulation testing, formulation considerations (buffers, excipients, stability), contamination control, sterilization methods and lyophilization challenges for injectable biologics.


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