罗建军博士在无锡药明康德生物技术股份有限公司(药明康德集团的全资子公司)担任生物制剂/灌装/成型的执行主任。他从4年前加入药明康德，领导建立了上海的生物制剂研发实验室，无锡符合中美欧cGMP的制剂灌装冻干生产车间以及上海金山毒素蛋白偶联体在隔离器下运行的GMP生产车间。无锡的制剂灌装冻干生产车间刚刚升级成国内首家100%全抛弃型的制剂灌装冻干生产线。迄今为止，他领导研发出50多个制剂配方，60多个GMP生产批次。其中包括首个中国制造的生物药被FDA审核通过而在美国做临床二期，首个毒素蛋白偶联体在澳大利亚做临床一期，首个生物药被欧盟EMA审核通过而在欧洲做临床二期，以及首个今年正在进行的申报美国BLA的商业生产验证批。

他毕业于北京化工大学并于1988年获得化学工程学士学位，后于中国科学院过程工程研究所(前化工冶金所)获得硕士学位，并最终于加拿大达尔豪斯大学获得化工博士学位。他在新泽西州理工学院和罗格斯大学完成了博士后工作。他拥有20多年的工作经验，有超过10年的生物医药外包服务的研发和生产经验，先后在美国北卡拉来研究三角区的科比埃生物制药公司(KBI Biopharma)和康泰伦特制药公司 (Catalent Pharma Solutions)。他在美国康泰伦特公司的职责是无菌制剂部门的负责人和项目主任，以及作为无菌药物研发方面的专家协助全球市场开发。他成功地为三十多家客户开发了超过20种药物制剂，包括用于静脉，皮下和肌肉注射的液体和冻干粉剂，局部皮肤用液体和凝胶制剂，和以脂肪为基础的乳胶/脂质体形式的制剂。他参与研发的2个蛋白类药物获得美国医药食品监督局的批准，十多个在临床一期和二期阶段，还有几个在临床三期阶段。他还为二十多位客户提供包括QbD指导下的过程开发，毒理批次生产，试运行和指导过35多批的cGMP无菌灌装生产。

Dr. Jianjun (also known as JJ) Luo is an Executive Director from Wuxi Biologics, a company of WuxiAppTec Group. He is currently responsible for drug product formulation development and fill/finish manufacturing. Over 4 years ago, he joined WuxiAppTec and built biologics formulation development capability in Shanghai, GMP liquid fill and lyophilization capability using RABS system in Wuxi, and ADC isolator filling line in Jinshan, Shanghai. Recently, Wuxi filling line is upgraded using 100% disposables. He has led to develop more than 50 biologics formulation, and produce more than 60 GMP batches including the 1st biologics made-in-China approved for clinical trials by US FDA, the 1st ADC clinical trial in Australia, the 1st biologics clinical trial approved by EMA, and the 1st process validation aimed at US BLA filing this year.

He obtained his Bachelor degree in Chemical Engineering from Beijing University of Chemical Technology in 1988, Master degree from Institute of Process Engineering (formally known as Institute of Chemical Metallurgy), Chinese Academy of Sciences, and PhD in Chemical Engineering from Dalhousie University, Canada. He completed his post-Doctorial research at New Jersey Institute of Technology (NJIT) and then Rutgers University, USA. He has over 20 years working experience and more than 10 years direct CRO/CMO experience in biologics from KBI Biopharma and Catalent Pharma Solutions (spun off from Cardinal Health) both located at Research Triangle Park of North Carolina, USA besides WuXiAppTec. He was Formulation Head and Project Director and a subject matter expert in sterile drug development and manufacturing in Catalent. He developed more than 20 drug formulations for more than 30 customers. The formulation includes biological liquids and lyophilized powders for IV, IM or SC injections, topical liquids/gels, and lipid-based emulsion/liposome forms. He contributed to development of 2 protein drugs approved by FDA, dozens in clinical Phase I/II and a few drugs in Phase III. He performed process development via Quality-by-Design (QbD), toxicology batch production, engineering runs, and guided aseptic cGMP manufacturing for more than 20 customers in 35+ batches.