Formulation development - From candidate selection to IND ready in 8-12 weeks


Investigational New Drug (IND) application is a big milestone in the lengthy new drug formulation development process, and innovators are looking for a fast and cost-effective approach to bringing their new drugs from late discovery to IND submission from CDMO partners.

We offer an integrated pre-formulation service for our late discovery phase and early formulation development stage customers – “IEPP: IND Enabling Pre-formulation Package” to provide a fast and optimal preformulation and drug delivery technology assessment including animal PK studies to give their molecules the best chance of success at later stages, all in 8-12 weeks.

IEPP combines all analytics and services needed to develop the right formulation for IND filing, especially helping expedite the best drug candidate through developability assessment and develop the optimal formulation by the screening bioavailability enhancement technologies

First, we utilize an established process through fast and comprehensive physicochemical property characterizations to fully understand the molecule. Data includes Tm, pKa & LogP/D, solubility, permeability, dissolution, super-saturation, physical form, and chemical stability.

With the full set of data, we apply a complete spectrum of prediction tools including in-vitro, in-vivo, and in-silico to assess the developability of the drug candidate, such as formulation decision tree, DCS classification system (1,2) and Gastro Plus modeling.

In addition to the theoretical prediction tools, we also use real an
imal PK data to confirm if the drug exposure level can meet the needs for further formulation development. Rapid animal PK studies, confirmed in at least two species, require only 1-2 weeks and less than 1 g of the material.

More than 90% of molecules in today’s pipeline are poorly soluble and could not be further developed without bioavailability enhancing technologies3. WuXi STA has the full box of bioavailability enhancing technologies and extensive experience.

Benefits of WuXi STA’s IND Enabling Preformulation Package (IEPP):

Rapid developability assessment with various prediction tools and animal PK to identify the best drug candidate to move forward for IND filing

Bioavailability enhancement technology screening to develop the optimal formulation strategy that enables the drug ready for clinical trial testing

The streamlined approach allows innovators to advance candidates with a better chance of clinical success in significantly shorter timeframes and subsequently with a lower overall cost

1. Pharmaceutical amorphous solid dispersion: a review of manufacturing strategies, Acta Pharmaceutica Sinica B, 2021, ISSN 2211-3835

2. Adapted from James M. Butler, Jennifer B. Dressman: The Developability Classification System: Application of Biopharmaceutics Concepts to Formulation Development

3. American Pharmaceutical Review (2013) Ralph Lipp. The Innovator Pipeline: Bioavailability Challenges and Advanced Oral Drug Delivery Opportunities

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