Understanding and documenting the physicochemical properties of your therapeutic candidate is a critical component of your IND submission and will serve as the basis for a rationally designed formulation development program. At Formatech, our preformulation programs are custom-tailored to meet your product's development needs — from fully characterizing your candidate to filling in the gaps, as necessary, to complete your submission.

We offer two program formats that are molecule-specific:

• Stability FingerPrinting^® for Biotherapeutics
• Stability Profiling™ for small molecules and other chemical entities
  

The data generated in these programs has enabled Formatech to develop effective formulations for over one hundred clinical candidates. Additionally, the preformulation programs have assisted our clients with:

• Lead candidate selection
• Identifying stability indicating assays
• Evaluating product consistency during process scale-up and/or manufacturing process changes

To request more information on our preformulation services, please click here.  

Case Study – Increase Bioavailability

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Case Study – Formulation/Dosage Form Change

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Case Study – Analytical Development