(S)-1-(2-fluorophenyl) ethylamine plays a crucial role as a chiral building block in pharmaceutical synthesis. ω-transaminases are widely recognized as environmentally friendly and efficient catalysts for the preparation of chiral amines. In this study, we isolated a novel ω-transaminase, PfTA, from Pseudogulbenkiania ferrooxidans through gene mining in the NCBI database. By employing semi-rational design, we obtained a Y168R/R416Q variant with enhanced enzyme activity. This variant exhibited the ability to catalyze the synthesis of (S)-1-(2-fluorophenyl) ethylamine from 2-fluorophenone, achieving a yield of 83.58% and an enantioselectivity exceeding 99% after a 10 h reaction. Compared to the wild type, the specific enzyme activity of the Y168R/R416Q variant reached 47.04 U/mg, which represents an increase of 11.65 times. Additionally, the catalytic efficiency, as measured by k_cat/K_m, was increased by 20.9 times. Molecular docking and structural simulation analysis revealed that the primary factor contributing to the improved catalytic efficiency is the expansion of the enzyme's active pocket and the alleviation of steric hindrance.

Shipin Yu Fajiao Gongye

Optimized carbon source increased the titer of astaxanthin and the astaxanthin-to-carotenoid ratio in Phaffia rhodozyma

作者: Shao Dong ; Liu Yan ; Yang Yigong ; Wang Xiaoping ; Sun Xinqiang ; Xu Zuowu ; Chen Kejie ; Zhou Xuyan

To increase the titer of astaxanthin and the astaxanthin-to-carotenoid ratio in Phaffia rhodozyma fermentation,the types of bulk carbon sources and their combinations were investigated.The ratio of glucose to maltodextrin was determined in a 70 L fermenter,and the optimized process was scaled up in a 10 m3 fermenter.The results showed that molasses,glucose,maltodextrin and maltose syrup were favorable for the growth of P.rhodozyma,maltodextrin,maltose syrup,starch hydrolyzate and sucrose were beneficial to the synthesis of carotenoids,while maltodextrin,starch hydrolyzate and maltose syrup facilitated the production of astaxanthin.Maltodextrin combined with molasses or glucose resulted in the highest astaxanthin titers of( 58.7 ± 1.2) and( 55.1 ± 0.8) μg/m L,resp.The optimal ratio of glucose to maltodextrin of 1: 1 in a 70 L fermenter yielded an astaxanthin titer of( 341.0 ± 7.2) μg/m L,which is 4.08 mg/g dry cell weightWhen scaled up in a 10 m3 fermenter,the titer and the astaxanthin-to-carotenoid ratio were( 360.3 ± 0.8) μg/m L and 42.2%,resp.,while the astaxanthin content toward dry cell weight was 3.88 mg/g,which was slightly lower than that of lab scale fermentationIn summary,the types of carbon sources and their compositions were optimized for astaxanthin production,the results provided important reference for com. production of astaxanthin.

Fajiao Keji Tongxun

Effect of nutritional conditions and temperature on the production intensity of rifamycin B

作者: Chen Yingying ; Yang Yigong ; Wang Hongwei ; Xu Zuowu ; Shao Dong ; Sun Xinqiang ; Chen Kejie ; Zhou Xuyan

To further improve the titer and productivity of rifamycin B by Amycolatopsis mediterranei XC-301, the effects of initial glucose mass concentration of the fermentation medium, the combination of inorganic nitrogen source and substrate concentration were investigated in feeding shaker.Moreover, a temperature-variable cultivation strategy was further adopted to improve the dissolved oxygen level in the low oxygen period in a 70 L fermenter.The stability of the established process was further verified in 10 m∼3 fermenter.The results showed that the optimal initial glucose concentration was 80 g/L, the optimal combination of inorganic nitrogen sources was 6 g/L KNO_3 and 3 g/L(NH_4)_2SO_4 and the optimal substrate concentration was 115%.When the temperature-variable cultivation strategy was applied to the optimized fermentation medium, the dissolved oxygen level was increased between 92 and 155 h of the fermentationThe stability of 5 batches of pilot tests on the 10 m∼3 fermenter was tested.The titer of rifamycin B reached(25 647.6±326.6) μg/mL, which was 16.6% higher than that of the original process.

项与浙江昌海制药有限公司相关的新闻（医药）

2024-01-28

·蒲公英Ouryao

2023年FDA在中印现场检查回顾

转自：Julia快过年了，提前预祝大家新年好！阳历年是先过去了，过去的2023年，FDA现场检查开始回升甚至超出以前水平了，亲们的工厂是否有接受FDA的检查了呢？如果没有，但有在FDA登记或被客户提交地址作为生产场所的要开始准备了哦！这里根据FDA官方数据看板（datadashboard）发布的数据，对比了印度与中国在2023自然年（非美国财年）检查数据如下：注：检索日期以数据看板所登记的检查结束日期为2023年；筛选条件为人药和兽药项下非生物研究类，同一检查编号则合并为一次。按FDA一般录入时间来看，应有较多检查记录尚未录入数据显示，印度兄弟不仅接受的检查数量为中国的近三倍，且OVI比例明显高于中国企业。虽然这并不是2023年的全部数字，但从这些数据来看，可以直接入境检查的印度兄弟2023年压力显然有点大，而中国虽然申请VISA在一定程度上缓解短时压力，不过据说很多现场检查已经在路上，很多中国公司不是正在检查就是收到通知在准备检查的路上了。中国上述45个检查具体检查清单如下：Inspection End DateLegal NameClassification2023-03-09Xinghua Lianfu Food Co., Ltd. 兴化市联富食品NAI2023-03-24Huatai Pharma Inc. 德阳华泰生物医药VAI2023-05-19Qilu Pharmaceutical (Hainan) Co. Ltd 齐鲁制药（海南）VAI2023-05-25Sinopharm Weiqida Pharmaceutical Co. Ltd. 国药威奇达VAI2023-05-26Zhejiang Changhai Pharmaceuticals Co., Ltd. 浙江昌海制药NAI2023-05-26QINGDAO KANGDA FOODSTUFFS CO.,LTD INDUSTRIAL PARK BRANCH(NO.1 FACTORY) 青岛康大食品VAI2023-05-30Qilu Antibiotics Pharmaceutical Co. , Ltd. 齐鲁安替制药VAI2023-06-02Zhejiang Apeloa Tospo Pharmaceuticals Co., Ltd 浙江普洛德邦制药（PAI+监管）NAI2023-06-16Beigene (Suzhou) Co., Ltd. 百济神州（苏州）VAI2023-06-30Hainan Poly Pharm. Co., Ltd. 海南普利制药VAI2023-07-07Zhejiang Jiangbei Pharmaceutical Co., Ltd. 浙江江北制药NAI2023-07-14Novast Laboratories Ltd. 南通联亚药业VAI2023-07-20Zhejiang Xianju Pharmaceutical Co., Ltd. (Yangfu API). 浙江仙琚（杨府API）（PAI+监管）NAI2023-07-21Yichang Humanwell Oral Solid Dosage Plant 宜昌人福固体口服制剂厂NAI2023-07-28Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd. 浙江普洛康裕制药NAI2023-08-03Zhuhai United Laboratories Co. Ltd. 珠海联邦制药OAI2023-08-11Henan Dongtai Pharm Co., Ltd. 河南东泰制药NAI2023-08-18Guilin Pharmaceutical Co., Ltd. 桂林南药股份NAI2023-08-18Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd 杭州中美华东制药VAI2023-08-25Zhejiang Liaoyuan Pharmaceutical Co., Ltd. 浙江燎原药业VAI2023-08-25Qilu Pharmaceutical Hulun Buir Branch 齐鲁制药（内蒙古）有限公司呼伦贝尔分公司NAI2023-08-29Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Dongjin Road Site) 江苏恒瑞（东晋路工厂）VAI2023-09-01Jiangsu NHWA Pharmaceutical Co., Ltd. 江苏恩华药业VAI2023-09-07Zhejiang Apeloa Biotechnology Co., Ltd 浙江普洛生物科技VAI2023-09-08Jinhe Biotechnology Co., Ltd. 金河生物科技NAI2023-09-08Yichang Sanxia Pharmaceutical Co., Ltd. 宜昌三峡制药NAI2023-09-08Chengdu Shengnuo Biopharm Co Ltd 成都圣诺生物科技VAI2023-09-08Wanbang Biopharmaceuticals 万邦医药VAI2023-09-08Sichuan Deebio Pharmaceutical Co., Ltd. 四川德博尔制药OAI2023-09-08Zhejiang Peptites Biotech Co.,Ltd. 浙江湃汰生物VAI2023-09-14Zhejiang Ruibang Laboratories 浙江瑞邦药业VAI2023-09-15Shandong Xinhua Pharmaceutical Co., Ltd. 山东新华制药股份NAI2023-09-15Shandong Qilu King-phar Pharmaceutical Co., Ltd. 山东齐发药业NAI2023-09-15Yangzhou Liberty Pharmaceuticals Co. Ltd. 扬州联博药业VAI2023-09-15Linhai Tianyu Pharmaceutical Co., Ltd. 临海天宇药业VAI2023-09-21Shaanxi Hanjiang Pharmaceutical Group Co., Ltd (Gaoxin site) 陕西汉江药业（高新厂）VAI2023-09-22Zhejiang Rongyao Biotech Co., Ltd. 浙江荣耀生物科技NAI2023-09-22Shandong Anshun Pharmaceutical Co., Ltd. 山东安舜制药NAI2023-09-22Zibo Xinhua-Perrigo Pharmaceutical Co., Ltd. 淄博新华-百利高制药（注：MRA互认）NAI2023-10-27Beijing Sciecure Pharmaceutical Co Ltd 北京世桥生物VAI2023-11-10Shanghai Pharma Group Changzhou Kony Pharmaceutical Co., Ltd. 上药康丽（常州）药业NAI2023-11-10Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd. (FDF Site) 南京健友（制剂厂）VAI2023-11-17Jiangsu Intco Medical Products Co., Ltd. 江苏英科医疗制品VAI2023-12-01Hubei Zhuxi Humanwell Pharmaceutical Co. Ltd. 湖北竹溪人福制药NAI2023-12-08Shandong Xinhua Pharmaceutical Co., Ltd. FDF Plant 山东新华制药制剂厂NAI按地域分布情况如下：唯二的两家OAI为珠海联邦和四川Deebio，数据看板显示其历史检查情况如下：中印2009至今接受FDA检查数据图示如下（以美国财年计，仅统计drug项下Drug Quality Assurance）。从这些数据看，印度检查总次数约为中国的1.6倍，而中印截止目前OAI比例基本持平（约为12.5%）。期望在2024年度FDA检查高峰之后，回顾中印检查数据能看到更多中国药企通过FDA检查。最后祝正准备接受检查的朋友们顺利通过FDA检查！

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