The Captisol Team has over 150 years of experience in drug development, from preclinical through Phase IV (post-commercial) clinical studies.
While some partners prefer to keep development internal, we also assist clients in numerous development projects. In addition, EVOMELA®, NEXTERONE®, and SESQUIENT™ are three Captisol-enabled drug products the CyDex team selected for reformulation, performed initial development and conducted various proof-of-concept studies including clinical trials prior to licensing to partner that successfully registered and commercialized the product.
Our team has extensive, hands-on preclinical, CMC, clinical, orphan, ANDA, 505(b)(2), biowaiver, and NDA submission experience. In addition to Captisol material, we can perform formulation studies, advise on safety studies, guide regulatory strategies, and develop manufacturing processes, providing these services to big pharma, small biotech, academic groups, and non-profits. Please find a list of services we offer below:
Lab Contract Services -
- Solubility and Stability Evaluation
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Pre-Formulation / Feasibility Assessment
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Formulation Development
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Cyclodextrin Derivatives
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Drug / Cyclodextrin Mixtures
Consultant Services -
- Manufacturing Support Services
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Evaluation of Cyclodextrin Containing Formulation
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Clinical Trial Planning Consultation
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Regulatory Affairs Consultation