For information on our biologics services: VxP Biologics – Parenteral & Lyophilized Clinical Trial Materials
From clinical scale development to full commercialization, VxP Pharma develops innovative and timely solutions throughout the entire life cycle of drug development, respecting your confidentiality every step of the way and helping you get a quality product to market.
As a cGxP facility, we are committed to providing the highest quality standards in the industry. We also understand how important it is that extra care must be taken to ensure all equipment and processes are performing to proper specifications. We pay special attention to equipment qualification and process validation to provide complete regulatory compliance for our small molecule manufacturing clientele. We have the capabilities to develop and execute validation protocols required for your processes and equipment in accordance with cGMP guidelines.
- IQ/OQ/PQ/PV and utility qualification packages
- Environmental controls and monitoring
- Terminal sterilization procedures
- Aseptic processing
- Cleaning validation
- Process validation
Our process scientists can develop and validate an entire process or optimize individual steps in a current process to ensure the formulation is suitable for manufacturing in a scalable 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 production.
Whether your drug substance is destined for bulk storage or clinical supplies, we will formulate your product to the specific needs of your specific molecule and development program. At VxP Pharma, we have extensive experience with highly potent, cytotoxic, and complex formulation processes.
Solutions we can offer:
- Container/closure selection
- Manufacturing Scale-up and Technology transfer
- A wide range of analytical/bioanalytical and testing services
- Cytotoxic and complex formulations
VxP Pharma’s cGMP manufacturing facilities and expert staff 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. Our team supports clients with process development, formulation, and cGMP manufacturing of the final drug product. With demonstrated manufacturing experience of over 100 cGMP lots of sterile drug substance, we understand that successful cGMP production requires seamless integration of process and analytical development, product formulation, and regulatory (QA) management. At VxP Pharma, you have all of these groups working together to support your product timeline and budget.
In addition to the production of your bulk API, our complementary manufacturing facilities provide you with fully integrated end-to-end resources from concept to vial. As your program advances in the clinic, you’ll be confident knowing that VxP Pharma has the resources to efficiently scale-up your production requirements without changing facilities.