Pre-Formulation & Formulation Development
Clients come to us with a wide range of molecule including small molecules, oligonucleotides, vaccines, peptides, biosimilars, mAbs, and large protiens. We work with our clients to create a new formulation (or optimize an existing formulation) that is suitable for pre-clinical and clinical use. We deliver pre-formulation, excipient and formulation studies of parenteral, oral, and lyophilized formulations. Our goal for formulation development is to obtain a safe, effective product that is stable for years after manufacturing.
Solubility, pH, Forced Degradation with Heat, pH Adjustments, Peroxide, and Light
Excipient Studies, Co-Solvent Investigations, Short Term Stability
Dose and Route of Administration Analysis, Bulk Preparation, pKa and pI Studies
Our knowledgeable and experienced group of scientists can provide drug formulation process development solutions during your product development. As your product moves through the clinical trial process into commercial manufacturing environments, manufacturing scale and processes can change. Our process development team can ensure that you are prepared for the possibilities, and able to produce a reliable product utilizing a robust manufacturing process.
Lyophilizer – LyoStar II Freeze-Dryer
Development/Optimization of Lyophilization Cycle
Crystalline/Amorphous Characterization, Thermal Stability
Differential Scanning Calorimetry (DSC), Dielectric Analysis (DEA)
Differential Thermal Analysis (DTA), Thermoelectric Analysis (TEA)
Freeze-Dry Microscopy, Technology Transfer for Manufacturing
We have extensive experience in analytical development to create a robust method for analysis of your product. Whether starting from scratch or optimizing a method provided by our clients, we offer analytical development services that are customized to your product. We specialize in executing phase appropriate method validations which will support that method during each step in the drug approval process.
Method Transfer: Verification, Qualification, Validation
Liquid Chromatography, Gas Chromatography
Ion Chromatography, Capillary Electrophoresis
BioAssays, UV-Vis, Particle Analysis
At Singota, we utilize an Electronic Laboratory Notebook to provide access for our clients to testing data, results, and reports as we complete assays and post results. This system provides communication between our clients and our team that is protected, risk-free, and simple to use. Contact us with any questions you have about our drug development services.
Contact us with any questions you have about our pharmaceutical drug development services at – email@example.com