Virtual Pharma & Services for Lyophilized Products
As an industry leader, VxP Pharma has experience in a wide array of lyophilized products from anti-infectives to vaccines, nanoparticles to large molecules and biological preparations. We can support all of your product development, cycle design, and lyophilization needs, from R&D and Pilot scale batches, to cGMP Clinical production and beyond.
Comprehensive Lyophilization Services
VxP Pharma’s team of experienced scientists can assist you in all stages of your project, from lyophilization cycle development and optimization to commercial manufacturing of lyophilized products.
The new state-of-the-art formulation laboratory includes some of the best trained and most experienced Lyophilization scientists in the field, and the team is backed by vigorous quality systems to provide a seamless collaboration from tech transfer through production for small molecules to biologics. With the extensive Lyophilization capabilities at the manufacturing facility, as well as the experienced staff on hand, we can work with you to achieve your goals.
Manufacturing of Lyophilized Products
The sterile manufacturing facilities can provide cGMP/CMC clinical scale and research-scale production of lyophilized products within an operational Grade A (ISO 5) environment during processing. The 48 square-foot Hull lyophilizer chamber can accommodate up to 15,000 units (per vial size) and comes integrated with the state-of-the-art, isolator-based automated filling line for an efficient transition from filled solution to lyophilized product.
Utilizing virtual companies at this stage to help with the early development work can save years of time and will free up the team to focus on more important projects.
CMC and Scale Up Development
VxP Pharma uses R&D and pilot scale freeze dryers for development projects that are based on robust and cost-efficient lyophilization processes. The formulation team has experience in screening effective combinations of solvents, buffers, bulking agents, and lyo/cryo-protectants for providing a robust final product these qualities:Low residual moisture/solvent, formation of solid/attractive cake, quick and complete reconstitution, and that it resists physical/chemical degradation.
Using these lab-scale freeze dryers, the formulation team can develop compounding processes and lyophilization cycles that can be seamlessly transferred from lab-scale to the cGMP production scale freeze dryer for plant-scale operation.
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