This document announces a protein drug formulation development training class hosted by RongJie Bio Process (Suzhou) Co., Ltd. on November 17, 2016 in Zhuhai, China. The training will focus on regulatory considerations for biopharmaceutical drug products, high throughput formulation development techniques, and challenges in developing and manufacturing protein drug products. It provides details on the event location, contact information, training fees, and agenda. The key speaker, Dr. Danny Chou, is introduced, who has over 15 years of experience in protein formulation development and analysis.
2. 荣捷生物工程（苏州）有限公司
RongJie Bio Process（Suzhou）Co.,Ltd
培训内容
1. Regulatory consideration for development of biopharmaceutical drug products (from global
perspective, including the FDA)
·Factors affecting efficacy and safety of biopharmaceuticals and their
relevance to product development
[影响生物药功效及安全性的因素及它们与产品开发的关系]
·Protein aggregation and immunogenicity.
[蛋白聚集和免疫原性]
·potential mechanism of immunogenicity to biopharmaceuticals and how
they are related to establishment of CQA....
[潜在的免疫原性基础机制以及它们如何与生物药物产品中的关键质量属性
（CQA) 建立相关]
·Regulatory aspects for the formulation of biologics.[生物制品的监管方面]
·Other regulatory issues associated with biological product development
[其他与生物制品开发相关的监管问题]
2. High throughput formulation development, process development, and candidate selection/
developability assessment.[高通量制剂开发、工艺开发、以及候选者选择/开发性评价]
·The main drivers for development of a rapids screening methodology for
protein stability (focus on aggregation).
[开发快速筛选蛋白稳定性（聚焦于蛋白聚集）方法的主要驱动力]
·Foundation for a rational approach to enhance physical stability of
proteins in solution.
[提高蛋白在溶液中物理稳定性的合理方法的基础]
·The advantages of applying orthogonal analytical technologies that can
both predict and measure protein aggregation.
[应用能预测和测量蛋白聚集的正交的分析方法的优势]
·A case study using DOE-based approach with high throughput analytical
tools to identify key factors that influence stability of a protein
(IgG) in solution.
[应用带高通量分析工具的基于 DOE 的方法来鉴定关键的影响蛋白（单抗）在溶
液中稳定性的因素]
3. Challenges in the development and manufacture of protein drug products. Key lessons
learned from commercial drug product development and manufacturing (how to address
challenges related to manufacturing scale-up for commercial manufacturing of protein
pharmaceuticals)[蛋白质药物产品开发和制造的挑战。 从商业药物产品开发和制造中获得的
主要经验教训（如何应对与蛋白质药物商业制造的生产规模相关的挑战）]
·Introduction to biopharmaceutical development process.[生物制药开发工艺介绍]
·Selection of drug product configuration.[选择药物产品结构]
·Drug product process development.[药物产品工艺开发]
·Challenges with key unit operations.[关键单元操作中的挑战]
·Examples from literature.[文献中的例子]
·Stress studies and scale up.[压力研究和规模放大]
·Packaging and components.[包装和组分]
3. 荣捷生物工程（苏州）有限公司
RongJie Bio Process（Suzhou）Co.,Ltd
主讲人简介
Danny K. Chou, Pharm.D., Ph.D., MBA
1752 257th St, Lomita, CA 90717
Pharmd98@gmail.com
(USA) 303-483-3690
WeChat: 周可乘 (Danny Chou)
资历概况
SUMMARY OF QUALIFICATIONS
•生物制药行业资深制剂专家，具有大分子蛋白药物处方、制剂配方与成品剂型的丰富专业经验，并研发和
生产外包服务管理经验。
•有超过 15 年蛋白制剂配方开发和蛋白药物分析经验以及 17 年以上的临床结合研发的经验。
•专注于提高液体或固体蛋白在工艺生产、储存和传输过程中稳定性的研究。
Biography
Dr. Danny K. Chou is a biopharmaceutical industry veteran with expertise in
biopharmaceutical characterization, formulation development,process development,and
advanced technologies for protein aggregate/subvisible particle analysis. Currently, Dr. Chou is
the Founder and President of Compassion BioSolution, a biopharmaceutical consultancy and
analytical testing service provider that serves clients throughout the world. Prior to starting
Compassion BioSolution, Dr. Chou was a lead formulation scientist at Gilead Sciences, where
he successfully converted IV formulations of monoclonal antibodies to high concentration
formulations that are more stable and can be easily administered by subcutaneous injection.
Besides starting the biotech industry’s first CRO focusing on characterization of protein
particles and serving as the Director of Pharmaceutical Development at Integrity Bio, Dr. Chou
also held scientific leadership positions at Genzyme and Amgen Corporations.
In the past 15 years, Danny has developed stable pharmaceutical dosage form for proteins,
monoclonal antibodies, peptides, and oligonucleotides for clients ranging from small start-up
biopharmaceutical companies to Fortune 500 pharmaceutical companies. Danny received his
PhD from the University of Colorado Center for Pharmaceutical Biotechnology under the
tutelage of Professor John Carpenter and his PharmD from the University of Florida.
![荣捷生物工程（苏州）有限公司
RongJie Bio Process（Suzhou）Co.,Ltd
培训内容
1. Regulatory consideration for development of biopharmaceutical drug products (from global
perspective, including the FDA)
·Factors affecting efficacy and safety of biopharmaceuticals and their
relevance to product development
[影响生物药功效及安全性的因素及它们与产品开发的关系]
·Protein aggregation and immunogenicity.
[蛋白聚集和免疫原性]
·potential mechanism of immunogenicity to biopharmaceuticals and how
they are related to establishment of CQA....
[潜在的免疫原性基础机制以及它们如何与生物药物产品中的关键质量属性
（CQA) 建立相关]
·Regulatory aspects for the formulation of biologics.[生物制品的监管方面]
·Other regulatory issues associated with biological product development
[其他与生物制品开发相关的监管问题]
2. High throughput formulation development, process development, and candidate selection/
developability assessment.[高通量制剂开发、工艺开发、以及候选者选择/开发性评价]
·The main drivers for development of a rapids screening methodology for
protein stability (focus on aggregation).
[开发快速筛选蛋白稳定性（聚焦于蛋白聚集）方法的主要驱动力]
·Foundation for a rational approach to enhance physical stability of
proteins in solution.
[提高蛋白在溶液中物理稳定性的合理方法的基础]
·The advantages of applying orthogonal analytical technologies that can
both predict and measure protein aggregation.
[应用能预测和测量蛋白聚集的正交的分析方法的优势]
·A case study using DOE-based approach with high throughput analytical
tools to identify key factors that influence stability of a protein
(IgG) in solution.
[应用带高通量分析工具的基于 DOE 的方法来鉴定关键的影响蛋白（单抗）在溶
液中稳定性的因素]
3. Challenges in the development and manufacture of protein drug products. Key lessons
learned from commercial drug product development and manufacturing (how to address
challenges related to manufacturing scale-up for commercial manufacturing of protein
pharmaceuticals)[蛋白质药物产品开发和制造的挑战。 从商业药物产品开发和制造中获得的
主要经验教训（如何应对与蛋白质药物商业制造的生产规模相关的挑战）]
·Introduction to biopharmaceutical development process.[生物制药开发工艺介绍]
·Selection of drug product configuration.[选择药物产品结构]
·Drug product process development.[药物产品工艺开发]
·Challenges with key unit operations.[关键单元操作中的挑战]
·Examples from literature.[文献中的例子]
·Stress studies and scale up.[压力研究和规模放大]
·Packaging and components.[包装和组分]](data:image/gif;base64,R0lGODlhAQABAIAAAAAAAP///yH5BAEAAAAALAAAAAABAAEAAAIBRAA7)