Problem solving, Data Interpretation, and Trouble Shooting. Improve your molecule's solubility, stability, inability to crystallize, hygroscopicity, manufacturability, filterability, compressability or other production issues...
Triclinic Labs' scientific staff can help with data interpretation, project planning, and problem solving, whether data are collected in our lab or yours. They can also aid in selection of the appropriate CRO to meet your other development needs.Project planning and data interpretation are much more critical project components than is data collection. We believe that each project is unique because each molecule has a unique set of physical properties. Even for something as apparently straightforward as solid form screening, one protocol does not apply equally well to all molecules. For problems such as changing drug product performance, loss of crystallization control, or inconsistent API properties batch-to-batch, it is critical to utilize existing data and plan an efficient pathway to identification of the cause. At Triclinic we bring experience and proven creativity to that process.
Problems we can help with:
- Non-optimal drug substance properties: (solubility, stability, inability to crystallize, hygroscopicity, manufacturability, filterability, compressability)
- Polymorphic Determination and Control (Late stage form changes)
- Salt Selection and Screening
- Solid-state Property Optimization
- Cocrystal Screening, Formulation, Development
- Intellectual Property Consulting (Patent Prosecution and Litigation)
- Amorphous Material Characterization and Analysis (stability analysis)
- Analytical Method Development, Validation, Release testing - even at ultra low loading (<5% w/w).
Also:
- Contaminant Identification
- Counterfeit Drug Analysis
- Reproduction of Prior Art
- Chiral Resolution
- cGMP and non-GMP Analytical and Crystallization Method Development
- Failure on Stability or Storage
- Pharmaceutical and Fine Chemical Material Characterization
- Analysis of Prior Experiments and Procedures
- Short Courses and Training on Physical, Analytical, and Organic Chemistry