Precision -Biopharmaceutical Services
Combining disruptive technology platforms with unparalleled genomic medicine development expertise, Precision NanoSystems’ Biopharmaceutical Services accelerates the development of lipid nanoparticle (LNP) formulations and drug products.
Partner with Biopharmaceutical Services to design a payload based on your target gene of interest and develop the formulation, processes, analytics and manufacturing protocols for preclinical to clinical drug development. Our team of scientists optimizes the use of limited materials in scaling drug products from discovery to large-scale manufacturing for a broad range of payloads and carriers with the NanoAssemblr® and GenVoy™ technology platforms. Get started with a well-defined project plan and milestones, deliverables, timeline and budget customized to your needs.
Partner with Biopharmaceutical Services on projects that span the entire drug development process, including proof-of-concept studies in early discovery, lead candidate development in scale-up and optimization and technology transfer of manufacturing processes for cGMP production.
Screening
- Identify and validate drug targets in vitro
Formulation Development
- Optimize physicochemical properties and biological activity
- Identify critical quality attributes (CQAs) and draft drug product specifications
Process Development
- Establish critical process parameters (CPPs) for downstream processing, including tangential flow filtration (TFF) and sterile filtration
Scale-Up
- Confirm equivalency with demonstration batches
- Prepare and test batches to support GLP-Tox studies
Technology Transfer & Manufacturing
- Transfer equipment, materials and analytical methods to GMP manufacturing site
- Prepare GMP Master Batch Records
- Manufacture GMP batches for Phase I and II clinical trials
Chemistry Manufacturing & Controls (CMC) Support
- Provide oversight for the manufacture and testing of engineering and GMP batches
- Assist with CMC Regulatory Submissions
Analytical Services
- Develop analytical methods for nanoparticle formulations and raw materials