Crystal Pharmatech is a technology-driven contract research organization (CRO) that focuses on materials science and engineering for drug development. We partner with clients to ensure comprehensive solutions for their needs in solid-state research, crystallization process development, and preformulation studies. We guide clients in the discovery and selection of the optimal solid phase for drug development using all aspects of pre-formulation studies, including API process and formulation development, regulatory support and intellectual property protection. Founded in 2010, Crystal Pharmatech has business relationships with over 150 global pharmaceutical companies. High quality service, a culture of confidentiality, and fast turnaround with cost-effective pricing are our trademarks. As we continue to grow, Crystal Pharmatech will always keep customers our number one priority. We will also continue to be at the forefront of innovation in the field of solid-state chemistry so that our customers can reap the benefits of key discoveries in an ever changing field. Our Scientific Advisory Board includes global leaders in drug development covering amorphous dispersions, co-crystals, crystallization, solid forms, formulation and pre-formulation. The role of our board is all encompassing while we search for new scientific areas for internal and external projects. **Selected Publications** - Ann W. Newman, Robert M. Wenslow. Solid form changes during drug development: good, bad, and ugly case studies. *AAPS Open* 2016 - Yaling Wang, Alex M. Chen. *Stereoselective Synthesis of Drugs and Natural Products* Chapter 56 - Crystallization-based Separation of Enantiomers, John Wiley & Sons Inc., 2013 - Ping Li, Chu Yueying, Lin Wang, Robert M. Wenslow, etc. Structure Determination of Theophylline-Nicotinamide Cocrystal: A Combined Powder XRD, 1D Solid-State NMR, and Theoretical Calculation Study. *Cryst Eng Comm*, 2014, Accepted Manuscript - Yuejun Song, Bo Tan, Lianyan Wang, Robert M. Wenslow, ect. Physicochemical characterization of felodipine-kollidon VA64 amorphous solid dispersions prepared by hot-melt extrusion. *J Pharm Sci*, 2013, 102(6): 1915-23 - Ann W. Newman. Specialized Solid Form Screening Techniques. *Org Proc Res Dev*, 2013, 17, 457-471
Crystallization is a critical unit operation in API manufacturing. Desired product quality attributes can be obtained economically with high efficiency through well-designed and controlled crystallization processes. Successful crystallization development is based on a fundamental understanding of physicochemical and engineering principles, implementation and development of technologies and expertise in specialized areas.
Focused Analytical Solids Testing (FAST)
Crystal Pharmatech is offering FAST for many routine analyses encountered during pharmaceutical development. The FAST concept is directly aligned with our goal of partnering with organizations instead of merely providing data. Every FAST result will be accompanied with interpretation that is aimed at solving your specific development needs. We also promise FAST lives up to its' acronym with our timing and quality guarantee. We're not happy unless you're happy. With FAST, you can have the solid state characterization lab you've always wanted in-house.
|Test Item||Sample Amount (mg)||Turnaround Time (working days)|
|X-ray Power Diffraction (XRPD)||2-50||2|
|DSC (10 °C/min)||2-20||2|
|mDSC (30 °C/min)||2-20||2|
|TGA (10 °C/min)||2-20||2|
|Particle Size Analysis (PSD)||50-100||2|
|Polarized Light Microscopy (PLM)||2-20||2|
|Dynamic Vapor Sorption (DVS)||20-100||5|
|Solid State NMR (ssNMR)||200-500||5|
Understanding the physicochemical risks associated with your compound are paramount to successful formulation development. Crystal Pharmatech will systematically evaluate your compound and clearly map out the risks going forward.
Areas that are evaluated include:
It is critical to understand the solubility of a compound in a wide variety of solvents and vehicles for early pharmacokinetic and formulation studies. An understanding of solubility and solid forms is needed to help prevent crystallization from supersaturated solution formulations and prevent form conversion in suspension formulations. We have well established vehicle platforms and workflows to quickly and accurately assess compound solubility (kinetic and equilibrium) and stability so that the proper vehicle is chosen for your particular study. Our scientists will work with you to find a formulation that ensures that a consistent and sufficient level of API is dosed to every animal.
Growing crystals acceptable for single crystal x-ray diffraction (SCXRD) structure determination is challenging and requires patience, intuition, and care. Our researchers have a high level of expertise in single crystal growth techniques and the physical and chemical properties of the material are examined to determine the best crystallization techniques.
Our methods include:
We know that the needs in early development are different from the needs in late development and we tailor our approach based on information from the client and our experience with a wide range of compounds. At Crystal Pharmatech, we utilize a unique screening approach that combines the speed of automated screening with the quality of manual screening. Our scientists will provide a screen that is on scale with your early or late stage compound. The information obtained can be used to select a form, help develop or modify existing crystallization and formulation processes, or provide intellectual property.
Benefits of our solid form screening and selection services include:
Characterization of an API or drug product is critical to determine if a single form or multiple solid forms are present. A wide variety of solid-state techniques are available in our laboratory to provide a comprehensive picture of your material. This type of information is important from a scientific, regulatory, and intellectual property standpoint. Whether it is a simple TGA analysis or a multi-dimensional ssNMR project, we will identify the most appropriate and most efficient method to identify and quantify solid phases in your drug substance and drug product samples.
Our solid state characterization services include:
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