Our Success Story of an Antifungal Drug Development
Take a look at our contributions to a partner project with a StartUp company
Turning a High-Risk Molecule into a Lifesaving Therapy
The Challenge
Amphotericin B is one of the world’s most effective antifungals, but systemically somewhat toxic.
A US-based StartUp company engineered a breakthrough molecule:
- Selective binding only to fungal Ergosterol
- Minimal interaction with human cholesterol
-Suitable for systemic (i.v.) application
The first formulation (micellar solution) required -20°C frozen storage for Phase I.
The Turning Point
After Phase I success, future clinical phases required:
- A stable formulation
- Scalable GMP manufacturing
- Documented scientific and regulatory strategy
Antaran Research Institute (RI) took over formulation/process DP leadership in CMC.
What Antaran RI delivered
1. Strategic Formulation Leadership
Antaran RI led a structured partner assessment and selected Leukocare AG, Germany, as formulation and process development partner.
Outcome:
- Stable sterile lyophilizate stored at +5°C
- Robust formulation driven by Leukocare’s excipient expertise
- Multiple batches produced for toxicology studies
2. Industrial-Scale Drug Product Manufacturing Strategy
A second global assessment of GMP manufacturers was performed.
Outcome:
- US based GMP partner for manufacturing selected
- Two mid-scale GMP batches successfully manufactured
- Material prepared for multinational Phase II clinical trials
3. Regulatory & Scientific Backbone
Antaran RI generated the majority of CMC drug product formulation/process source documents:
- IND and IMPD sections
- Manufacturing process descriptions
- Stability and formulation rationales
Outcome:
- Smooth regulatory submissions- Strong scientific justification for a complex drug product
The Result
A high-risk molecule was transformed into a stable, scalable, Phase-II-ready antifungal therapy.
Antaran RI enabled
- Safe systemic new molecule in a complex and stable formulation and tech transfer to GMP
- Global clinical readiness
- A sustainable development path from innovation to real-world medicine
