Genovior provides full chemistry, manufacturing and controls (CMC) services for drug candidates. We have the experience and expertise in the development of small molecules, polypeptide and proteins for parenteral injectable formulation includes liquid solutions, suspensions, liposome and lyophilized products, etc. Especially, we can formulate a long-acting release delivery systems of PEGylation technology, microsphere, nanoparticles, micellar, nano-carrier and liposome. All formulations by Genovior can be scaled up in order to manufacture cGMP drugs for uses in clinical trials and commercialization. Genovior formulation development services include:
Pre-Formulation Development
- Excipient compatibility studies (excipient selection, salt form selection, buffer screening, etc.)
- Solubility and dissolution of APIs in different buffer and solvents
- Stability and accelerated stability of APIs services under various conditions
- Physicochemical properties measurement by modern analytical techniques
Long-Acting Release Delivery System Formulation Development
- pH-dependent release delivery system development
- Microsphere-based drug delivery systems development
- Polymeric nano-particle and nano-carries delivery system development
- Site-specific, lysine and cysteine PEGylation delivery system development
- Small and large unilamellar liposome delivery system development
Formulation Development
- Drug-excipient compatibility selection and optimization
- Injectable prototype development (dose suitability, bioavailability enhancement, etc.)
- New chemical entities (NCE) formulation development
- Novel formulations for improved delivery of existing formulation drugs
- Optimization of existing formulations (scalable, compliant and commercializable, etc.)
- Pre-clinical feasibility studies, physicochemical testing and various stress conditions studies
- Stability and accelerated stability of existing formulation drugs under various conditions
- Sterile lyophilized dosage formulations
- Sterile liquid (aseptically prepared) formulations (solutions, suspensions, liposomes, etc.)