Moving a drug candidate towards IND requires more than completing individual studies. The right chemistry, formulation, DMPK and toxicology strategies need to come together at the right time, with the right materials and data available to make critical decisions.
BioDuro brings these capabilities together in one integrated platform, helping biopharmaceutical companies move from late discovery to IND more efficiently.
Accelerating drug substance development
At BioDuro, a dedicated Discovery Process Chemistry team works alongside discovery scientists to accelerate the transition from late discovery to development. By engaging process chemistry early, we help establish scalable synthetic routes and streamline the path towards development-ready Drug Substance, reducing the time and complexity of scale-up.
IND-ready formulation in 8–12 weeks
Our formulation team combines conventional approaches with advanced bioavailability enhancement technologies, including Spray-Dried Dispersion (SDD) and Hot-Melt Extrusion (HME). These capabilities enable us to develop IND-ready formulations within 8–12 weeks, helping programmes move forward without unnecessary formulation delays.
Fast, integrated DMPK decision-making
Speed is critical when DMPK data informs the next development decision. BioDuro’s DMPK team can deliver results from both in vitro and in vivo studies within five days, providing timely data to guide candidate selection and IND-enabling studies. Our integrated approach also connects DMPK with pharmacology and toxicology, helping teams make development decisions with a complete view of the programme.
Toxicology without waiting for capacity
Through strategic partnerships and access to ample non-human primate resources, BioDuro helps minimise delays in GLP toxicology studies. This provides greater flexibility in planning IND-enabling programmes and helps keep critical studies on schedule.
From small molecules to new modalities
Our capabilities extend beyond small molecules to emerging modalities, including peptides. BioDuro has extensive peptide development experience, including oral peptide development with a programme that has advanced to Phase II.
From Drug Substance and Drug Product to DMPK and Toxicology, BioDuro connects the capabilities needed to advance your programme towards IND. With experience supporting programmes across the US, EU and APAC, we help simplify development, reduce handoffs and keep your programme moving.
Visit BioDuro at Booth #6N11 at CPHI Worldwide to discuss your IND programme with our team.
