At VxP Pharma, our goal is to assist our clients in identifying the best form of delivery and the most viable and robust manufacturing strategy for their lead candidate. Our aseptic manufacturing team has experience with essentially all types of formulations, including solutions, dispersions, emulsions, liposomes, suspensions, and nano-particles.
- Formulation Development
- Excipient Compatibility
- Sterilization Process Development
- Filter Compatibility Studies
- Container/closure Compatibility Studies
- Analytical Testing & Development
- Stability Testing
- Scale-up and Technology Transfer
If your molecule requires lyophilization, we can optimize the program cycles as needed and lyophilize the product in our cGMP facility. All of these options can be combined with our fill/finish and our analytical services to provide for you a stable drug product ready for clinical trials.
We provide services for:
- Sterile Vials (including dual-chamber)
- Pre-filled Syringes
- Ophthalmic Droppers
- Lyophilized Product
Sterile Liquid Injectables: VxP Pharma offers fully integrated GMP Class 100 Aseptic Filling Suites for preclinical and clinical supplies: sterile filling and capping of liquid-in-vial injectable drugs. Aseptic fill on a state-of-the-art fill / finish crimp-cap line, capable of aseptic filling 2 – 100 ml vials with dispensing volume of 0.5 ml – 50 ml. We have validated methods in place for multiple vial sizes up to 80,000 units per run.
Our facility is designed to provide multiple types of containment technology for an operational Grade A (ISO 5) environment during processing, as well as product containment for highly potent, cytotoxic, controlled substances (up to Schedule II) and radiolabeled products.
All areas of the aseptic processing facility are routinely monitored for viable and non-viable contamination via airborne and surface methods by the QC Microbiology Laboratory. Additional support is also included by the full service Analytical Chemistry Laboratory and Quality Assurance Department.