Panzitta Michele, Calamassi Niccolò, Sabatini Cristina, Grassi Marzia, Spagnoli Chiara, Vizzini Vittoria, Ricchiuto Elisa, Venturini Andrea, Brogi Andrea, Brassier Font Judit, Pontello Lino, Bruno Giorgio, Minghetti Paola, Ricci Maurizio
A. Menarini M.L.&S, Via R. Pilo 4, 50131 Firenze, Italy; AFI, Study Group on Product Lifecycle and Process Innovation, viale Ranzoni, 1 20041 Milano.
Department of Pharmaceutical Sciences, Università degli Studi di Perugia, via del Liceo 1, 06123 Perugia, Italy; AFI, Study Group on Product Lifecycle and Process Innovation, viale Ranzoni, 1 20041 Milano.
Int J Pharm. 2021 May 15;601:120551. doi: 10.1016/j.ijpharm.2021.120551. Epub 2021 Apr 6.
European Pharmacopoeia includes dedicated chapters for Raman, NIR and Chemometrics, as well as there is a lot of Academia research on the matter. Despite that, the word innovation is often associated to such tools and there is a still slow implementation at industry. The paper is the outcome of the Associazione Farmaceutici dell'Industria (AFI) Study Group on Process Innovation and Product Lifecycle; the aim is to describe some case studies referring to practical approaches in pharmaceutical industry, in order to depict challenges and opportunities for the implementation of spectroscopic techniques. Case studies include: feasibility and pre-screening evaluations, chemometric model development approaches, way for the method maintenance during commercial manufacturing, challenges for implementation on existing equipment and on sterile processes. Case studies refer to oral solid products, liquid products and sterile Active Pharmaceutical Ingradient (API) manufacturing. There are already successful and robust spectroscopic applications in pharmaceutical industry and the technology is mature: this is the outcome of a strong applied research performed at pharmaceutical production departments. It is necessary to acknowledge efforts done by industry as Research for strengthening the cooperation with Academia, so that advantage of process innovation might reach the patients in a fastest way.
《欧洲药典》设有拉曼光谱、近红外光谱和化学计量学的专门章节，并且学术界也有大量关于此方面的研究。尽管如此，创新一词常与这些工具相关联，但其在行业中的实施仍较为缓慢。本文是制药工业协会（AFI）工艺创新与产品生命周期研究小组的成果；目的是描述一些制药行业实际应用方法的案例研究，以阐述实施光谱技术的挑战与机遇。案例研究包括：可行性和预筛选评估、化学计量学模型开发方法、商业化生产期间方法维护的方式、在现有设备和无菌工艺上实施的挑战。案例研究涉及口服固体产品、液体产品和无菌活性药物成分（API）生产。制药行业已经有成功且可靠的光谱应用，并且该技术已经成熟：这是制药生产部门进行大量应用研究的成果。有必要认可行业为加强与学术界合作所做的努力，以便工艺创新的优势能够以最快的方式惠及患者。
