چاپ صفحه |  صفحه نخست سامانه |  نویسندگان |  اطلاعات تفضیلی |  دانلود مقاله | دانشگاه علوم پزشکی تبریز |
| نویسنده ثبت کننده مقاله | افسانه فرجامی |
| مرحله جاری مقاله | تایید نهایی |
| دانشکده/مرکز مربوطه | مرکز تحقیقات ایمنی غذا و دارو |
| کد مقاله | 79225 |
| عنوان فارسی مقاله | ارزیابی پایداری فیزیکو شیمیایی آنتی بادی مونوکلونال ریتوکسیمب رقیق شده بعد از انجماد-ذوب |
| عنوان لاتین مقاله | Physicochemical stability of diluted solutions of the monoclonal antibody rituximab under freeze-thaw stress |
| نوع ارائه | پوستر |
| عنوان کنگره / همایش | بیست و یکمین کنگره بین المللی شیمی تبریز |
| نوع کنگره / همایش | بین المللی |
| کشور محل برگزاری کنگره/ همایش | Iran (Islamic Republic) |
| شهر محل برگزاری کنگره/ همایش | تبریز |
| سال انتشار/ ارائه شمسی | 1401 |
| سال انتشار/ارائه میلادی | 2022 |
| تاریخ شمسی شروع و خاتمه کنگره/همایش | 1401/05/04 الی 1401/05/06 |
| آدرس لینک مقاله/ همایش در شبکه اینترنت | https://icc21.azaruniv.ac.ir/ |
| آدرس علمی (Affiliation) نویسنده متقاضی | 1 Food and Drug Safety Research Center, Tabriz University of Medical Sciences, Tabriz, Iran 2 Pharmaceutical Analysis Research Center, Tabriz University of Medical Sciences, Tabriz, Iran |
| نویسنده | نفر چندم مقاله |
|---|---|
| افسانه فرجامی | اول |
| ثمین حمیدی | دوم |
| عنوان | متن |
|---|---|
| خلاصه مقاله | Rituximab (RTX) is a chimeric monoclonal antibody (mAb) approved for the treatment of non-Hodgkin lymphoma, rheumatoid polyarthritis, and chronic lymphoid leukaemia [1,2]. Its anti-CD20 activity results in the elimination of CD20-positive cells. Due to its proteic composition, RTX is susceptible to undergo a range of chemical and physical degradation processes under different stress situations [3,4]. This research aimed to examine the stability of diluted RTX at 1 mg/mL and 4 mg/ml under various freeze-thaw cycles using orthogonal techniques including cation-exchange chromatography, size exclusion chromatography, attenuated total reflectance-Fourier infrared spectroscopy, and dynamic light scattering. The results indicated that diluted rituximab stored in polyolefine bags was stable following three freeze-thaw cycles. No evidence of physical or chemical instability was found. The hydrodynamic diameter of RTX was observed to be unchanged. The charge heterogeneity profile of stressed samples was unaffected by freeze-thaw cycles compared to the profile of the control sample. Through cation exchange chromatography, neither a new peak nor a decrease in the area under the curve was detected. There were no modifications to the secondary structures of the protein. However, to assure the biological stability of mAbs in addition to their physicochemical stability, additional study is necessary to test the bioactivity of the stressed sample using an appropriate bioassay method. |
| کلمات کلیدی | Physicochemical stability, Monoclonal antibody, Rituximab, Freeze-thaw, Stress |
| نام فایل | تاریخ درج فایل | اندازه فایل | دانلود |
|---|---|---|---|
| 2.pdf | 1401/05/08 | 146314 | دانلود |
| 20220730_103331.jpg | 1401/05/08 | 11049708 | دانلود |
