Commercial Manufacturing – Parenteral & Lyophilized

VxP Biologics can formulate your drug substance into a robust and scalable drug product in a wide variety of dosage forms. With VxP’s formulation development expertise, along with a comprehensive understanding of clinical and commercial pharmaceutical manufacturing processes, we can help you accelerate your product’s path from the lab to market. We currently offer

  • Preclinical
  • Early phase/late phase formulations for NCE drugs
  • OTC products
  • Generic products

Orphan Drug Candidates

Liquid Fill and Finish Capabilities

  1.  0.5mL to 100mL vial fill-finish capabilities
  2. 0.5mL to 30mL syringe fill-finish capabilities
  3.  Aseptic & terminal sterilized product manufacturing capabilities
  4. DEA schedule 2-5 production
  5.  Annual production capacity of up to 45 million vials
  6.  Ability to manufacture emulsions, suspensions, & highly complex injectables as well as organic solvents

EQUIPMENT

– Bausch & Ströbel
– Franz Ziel
– Integrated Project Services
– Optima
– IMA Group

Lyophilization

VxP Pharma provides development and manufacture of lyophilized products for both small and large molecule programs. We also provide services for your pre-clinical/tox studies with cGLP manufacturing of liquid and lyophilized drug product. Whether you are in early development and needing lyo cycle development and optimization, or needing full GMP manufacturing, our VxP team can help guide your project from concept to the clinic, and to market.

Some areas of specialization include:

Development Services

  • Low Temperature Thermal Analysis
  • Product Development
  • Cycle Design/Refinement
  • Finished Product Testing
  • Aqueous/Organic Solvents
  • Pilot Plant Scale-up

Preclinical/Tox Materials (cGLP) and Clinical Manufacturing (cGMP)

  • Sterile Bulk and Drug Product
  • 2cc to 160cc Presentations
  • 13-28mm Closures
  • Temp controlled compounding/filling
  • US and EU Compliant
  • Cytotoxic/Highly Potent Capabilities