VxP Biologics aseptic manufacturing team supports clients with process development, cGMP manufacturing, and formulation of the API.
We can help to optimize the capacity, eliminating the need for redundant technology transfer and qualifications. With this fully integrated development and manufacturing resources, we can support your program from concept to vial.
Process Development
The process development group can develop and validate an entire process or optimize individual steps in a previous process to ensure the entire process is suitable for manufacturing in a cGMP environment. From early-stage process development to final cGMP manufacturing, the aseptic manufacturing team works in sync with dedicated analytical chemistry groups to ensure product integrity throughout every step of development.
Formulation
Whether your drug substance is destined for bulk storage or finished product, we will formulate your product to the specific needs of your molecule and development program. At VxP Biologics, we have extensive experience with highly potent, cytotoxic, and complex formulation processes.
We provide services for:
- Sterile Vials
- Pre-filled Syringes
- 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.
cGMP ProductionThe parenteral formulation team has experience with essentially all drug product types and administration routes.
After initial cGMP production, we have the capabilities to efficiently scale-up the process to meet larger volume requirements for your product. The experienced teams can rapidly advance your product candidate through the clinic and onto the market by providing you with the necessary equipment and analytical testing every step of the way.
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.