35 ....................................................................................................................................................................................................................................................................................................................................................................................................................................................................... For us, there will always be a patient at the end of every project The increasing R&D focus of pharmaceutical companies on orphan indications and diseases characterized by substantial unmet therapeutic needs, and the rising incidence of cancer and age-related disorders pose the need for accelerated development in readiness for potentially fast-track approval procedures. More than 70% of molecules entering development or reaching the market are plagued with bioavailability problems and increasingly small molecules are complex, with an increased share of high potency API in the development pipeline along with limited data on the potency and associated industrial hygiene requirements. Meeting the changing dynamics in the supply chain, we pivot scientific excellence at the core of our business with expertise and experience that brings benefits across process R&D and development. Particle engineering expertise is shaping the future, helping meet unmet patient needs We have established a dedicated Particle Engineering team that has the expertise in gathering operational data, carrying out experimentation across crystallization, filtration and drying unit operations and implementing PAT tools to reduce cycle time and improve API flowability. Sustainability success in process development Deep expertise in process chemistry, analytic chemistry and process engineering Optimised crossfunctional working with reduced interfaces from laboratory to pilot to manufacturing More fundamental science than an empirical approach to solve particle engineering challenges High potent laboratory facility Optimal chemical process development with flow chemistry, green chemistry mindset addressing process safety concerns upstream The biggest driver is the growing percentage of drug candidates that suffer from poor water solubility and consequently poor bioavailability — various estimates range from 40%-70%. We are successfully integrating particle engineering into the process R&D mindset with the application of mixing models, development of an optimal solvent system, crystallization and milling processes, and the establishment of appropriate physical properties. Such an approach is contributing to improved manufacturing efficiency. Integration of crystallization fundamentals in the process development mindset Crystallization process checklists at different stages of process development (kick off, tech pack finalization) Use of PAT tools and synergy of particle science & engineering controls during Tech pack review Version and solid form screenings as integrated value offerings to early phase development business Induction of newer particle engineering technologies into capability building and strengthening micronisation capabilities
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