Aptuit’s API to IND 26 week service

In an interview Jamie Weishaar, account manager, sales at Aptuit, explained how the company’s ability to perform all services in-house allowed it to cut the time taken to perform tasks needed for regulatory submissions.

Prior to implementing INDiGO Aptuit had been taking 32-36 weeks to take an active pharmaceutical ingredient (API) to its investigational new drug (IND) application, according to Weishaar.

This improvement has been achieved by tightly integrating API manufacture, toxicology, pharmacokinetics and clinical supplies into a single project. Different aspects of work needed for regulatory submission are run in parallel, with preclinical research, clinical supplies formulation and development and IND preparation occurring simultaneously.

Included in the services is Aptuit’s expertise in amorphous dispersion, which can improve the bioavailability of poorly soluble compounds.

Since all these services are all performed in-house Aptuit is not constrained by third parties, allowing it to expedite aspects of work to counteract difficulties and delays.

Although these factors have sped up the regulatory process 26 weeks is still the minimum time to IND, with Aptuit saying that some compounds and project requirements may take longer.

Quick off the blocks​

Weishaar said that INDiGO has been well received so far, with several clients currently signed up to use the service. The first of these is due to file its IND in July.

This client took advantage of Aptuit’s API creation programme, which adds a minimum of 26 weeks to the time to IND but provides a complete service from start to regulatory submission.