Analytical method development for analysis of SAAP-148 in the Drug Product

With the NADP Lead Development Voucher a reversed phase UHPLC (Ultra-High Pressure Liquid Chromatography) method for the analysis of SAAP-148 in Hypromellose gel drug products was successfully developed. The method can now be applied for drug product batch release and stability testing prior to GLP (animal toxicity) and GMP (human clinical) studies. This voucher helped to go into the next phase thanks to investment from angel investors. Although the NADP voucher certainly contributed to this, the amount is not high enough to get the intended funding from VCs, and you do need it to really move forward. This requires a solid and well-documented PoC study (usually in mice) and that simply cannot be done if you really want to do a good study.

Dr. Remko van Leeuwen, Madam Therapeutics