3 minute read
Long-acting injectable (LAI) drug products promise to transform the management and treatment of a range of diseases, addressing issues including lack of therapeutic adherence and limited access to healthcare infrastructure. However, their manufacture is highly complex, which currently is a great barrier to the development of generics and re-formulated/differentiated products. There is limited research exploring the quality attributes that underpin the manufacturing of LAI drug products. A key challenge is that product attributes, e.g. release profile, are sensitive to manufacturing process, affecting performance and quality.
NPL scientists will contribute to a new two-year research project to develop 3D chemical measurements of polymer-based drug carriers using correlative chemical analysis by X-ray photoelectron spectroscopy, Stimulated Raman scattering microscopy and secondary ion mass spectrometry imaging.
MESOX, an award-winning SME based in Birmingham which pioneers highly engineered pharmaceutical carrier technologies for therapeutic development – in partnership with NPL and Certara, has secured Innovate UK funding to develop a scalable and cost-effective process platform that could significantly facilitate the sustainable manufacturing of LAI formulations by de-risking product development and streamlining decision making.
The new project will also provide NPL with the opportunity to develop a correlative approach to 3D chemical measurements and expand the current offer for the measurement of formulated particle-based products, including next generation analytical methods to enable precision therapeutic targeting, and excitingly, to link all of this to mechanistic pharmacokinetic modelling.
Dr Ali Al-khattawi, CEO, MESOX said: “We are excited to be working in partnership with NPL and Certara to develop the world’s first accelerated long-acting injectables platform, de-risking manufacturing of these critical formulations and delivering cost-effective controlled-release therapies to patients globally. This is our third collaborative project with NPL where we have successfully utilised the advanced analytical capabilities and world-class expertise of NPL scientists to help us transform the formulation development landscape and deliver the next-generation of hybrid/505(b)(2) pharmaceuticals at speed and resource-efficiency.”
Dr Yiwen Pei, Senior Scientist, NPL said: “I am very passionate about this new project. By developing a 3D correlative chemical analysis approach for these novel polymeric pharmaceuticals, we can support MESOX in decision making by establishing the link between product attributes and their manufacturing process parameters, leading to more sustainable medicine manufacturing.”
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11 Jul 2024