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Detection and quantitation of host cell proteins in monoclonal antibody drug products using automated sample preparation and data-independent acquisition LC-MS/MS

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Journal of Pharmaceutical Analysis 2021年第6期11卷 726-731页

作者： Lisa Strasser Giorgio Oliviero Craig Jakes Izabela Zaborowska Patrick Floris Meire Ribeiro da Silva Florian Füssl Sara Carillo Jonathan Bones Characterization and Comparability Laboratory NIBRT-National Institute for Bioprocessing Research and TrainingDublinA94 X099Ireland School of Chemical and Bioprocess Engineering University College DublinDublinD04 V1W8Ireland

Ensuring the removal of host cell proteins(HCPs) during downstream processing of recombinant proteins such as monoclonal antibodies(m Abs) remains a challenge.Since residual HCPs might affect product stability or safety,constant monitoring is required to demonstrate their removal to be below the regulatory accepted level of 100 ng/mg.The current standard analytical approach for this procedure is based on ELISA;however,this approach only measures the overall HCP content.Therefore,the use of orthogonal methods,such as liquid chromatography-mass spectrometry(LC-MS),has been established,as it facilitates the quantitation of total HCPs as well as the identification and quantitation of the individual HCPs present.In the present study,a workflow for HCP detection and quantitation using an automated magnetic bead-based sample preparation,in combination with a data-independent acquisition(DIA) LC-MS analysis,was established.Employing the same instrumental setup commonly used for peptide mapping analysis of m Abs allows for its quick and easy implementation into pre-existing workflows,avoiding the need for dedicated instrumentation or personnel.Thereby,quantitation of HCPs over a broad dynamic range was enabled to allow monitoring of problematic HCPs or to track changes upon altered bioprocessing conditions.

关键词： Data-independent acquisition Host cell proteins Critical quality attributes Liquid chromatography-mass spectrometry Monoclonal antibody Chinese hamster ovary cells

Use of subcutaneous tocilizumab to prepare intravenous solutions for COVID-19 emergency shortage:Comparative analytical study of physicochemical quality attributes

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Journal of Pharmaceutical Analysis 2020年第6期10卷 532-545页

作者： Natalia Navas Jesús Hermosilla Anabel Torrente-Lopez Jose Hernandez-Jimenez Jose Cabeza Raquel Perez-Roblesa Antonio Salmeron-García Department of Analytical Chemistry Science Faculty/Biomedical Research Institute ibs.GranadaUniversity of GranadaGranadaE-18071Spain UGC Farmacia Hospitalaria Biomedical Research Institute ibs.Granada.Hospital Universitario San Cecilio de GranadaGranadaE-18012Spain

COVID-19,a disease caused by the novel coronavirus SARS-Co V-2,has produced a serious emergency for global public health,placing enormous stress on national health systems in many countries.Several studies suggest that cytokine storms(interleukins)may play an important role in severe cases of COVID-19.Neutralizing key inflammatory factors in cytokine release syndrome(CRS)could therefore be of great value in reducing the mortality rate.Tocilizumab(TCZ)in its intravenous(IV)form of administration-Ro Actemra?20 mg/m L(Roche)-is indicated for treatment of severe CRS patients.Preliminary investigations have concluded that inhibition of IL-6 with TCZ appears to be efficacious and safe,with several ongoing clinical trials.This has led to a huge increase in demand for IV TCZ for treating severe COVID-19 patients in hospitals,which has resulted in drug shortages.Here,we present a comparability study assessing the main critical physicochemical attributes of TCZ solutions used for infusion,at 6 mg/m L and 4 mg/m L,prepared from Ro Actemra?20 mg/m L(IV form)and from Ro Actemra?162 mg(0.9 m L solution pre-filled syringe,subcutaneous(SC)form),to evaluate the use of the latter for preparing clinical solutions required for IV administration,so that in a situation of shortage of the IV medicine,the SC form could be used to prepare the solutions for IV delivery of TCZ.It is important to remember that during the current pandemic all the medicines are used off-label,since none of them has yet been approved for the treatment of COVID-19.

关键词： COVID-19 Tocilizumab Critical quality attributes IV and SC medicines

Spectra selection methods:A novel optimization way for treating dynamic spectra and in-line near infrared modeling

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Journal of Innovative Optical Health Sciences 2020年第4期3卷 28-38页

作者： Haiyan Wang Ronghua Liu Lei Nie Dongbo Xu Wenping Yin Lian Li Hengchang Zang School of Pharmaceutical Sciences Shandong University Wenhuaxi Road 44 Jinan 250012P.R.China National Glycoengineering Research Center Shandong University Wenhuaxi Road 44 Jinan 250012 P.R.China Shandong SMA Pharmatech Co. Ltd 165Huabei Rd.High&New Technology Zone Zibo Shandong 0533P.R.China

Near infrared(NIR)spectroscopy is now widely used influidized bed granulation.However,there are still some demerits that should be overcome in practice.Valid spectra selection during modeling process is now a hard nut to crack.In this study,a novel NIR sensor and a cosine distance method were introduced to solve this problem in order to make thefluidized process into"visualization".A NIR sensor wasfixed on the side of the expansion chamber to acquire the NIR spectra.Then valid spectra were selected based on a cosine distance method to reduce the influence of dynamic disturbances.Finally,spectral pretreatment and wavelength selection methods were investigated to establish partial least squares(PLS)models to monitor the mois-ture content.The results showed that the root mean square error of prediction(RMSEP)was 0.124%for moisture content model,which was much lower than that without valid spectra selection treatment.All results demonstrated that with the help of valid spectra selection treatment,NIR sensor could be used for real-time determination of Critical quality attributes(CQAs)more accurately.It makes the manufacturing easier to understand than the process parameter control.

关键词： Near infrared spectroscopy fluidized bed granulation Critical quality attributes real-time monitoring spectra selection

Granulation process analysis technologies and potential applications in traditional Chinese medicine

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Acupuncture and Herbal Medicine 2022年第1期2卷 9-24页

作者： Tongcan Cui Yizhe Hou Huimin Feng Sijun Wu Wenlong Li Zheng Li College of Pharmaceutical Engineering of Traditional Chinese Medicine Tianjin University of Traditional Chinese MedicineTianjinChina State Key Laboratory of Component-Based Chinese Medicine Tianjin University of Traditional Chinese MedicineTianjinChina

Pharmaceutical production is changing from batch production to continuous production,during which granulation is one of the most important unit operations.The quality of mass-produced products is traditionally guaranteed by conducting off-line testing,which cannot meet the demand of continuous production for real-time monitoring of critical process parameters and Critical quality attributes(CQAs)of the pharmaceutical granulation technology.Since the U.S.Food and Drug Administration proposed process analytical technology(PAT)in 2004,many PAT tools have been developed to monitor the granulation process and provide information regarding the granulation operation conditions and endpoint determination.In this article,we review the recent research and application of two PAT modes in the granulation process,namely,single CQA and multi-CQA PAT,with the aim to provide references for comprehensively improving the technological level of the pharmaceutical granulation process.Furthermore,the potential applications in traditional Chinese Medicine are discussed.

关键词： critical process parameters Critical quality attributes Pharmaceutical granulation technology Process analytical technology