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

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

Our capabilities include support for the following dosage forms:

  • Solutions
  • Suspensions
  • Emulsions
  • “Nano-Space”-Nanoparticles, Nanoemulsions, and Liposomes
  • Lyophilized Products
  • Generic and Innovative Products
  • Cytotoxics
  • Organic Solvents
  • Controlled substances
  • Potent compounds
  • Lyo cycle development

Formulation development equipment:

  • DSC
  • TGA
  • Zetasizer
  • Homogenizer
  • Microfluidizer
  • Extruder
  • Probe Sonicator
  • Lyophilizer