荣捷生物工程（苏州）有限公司 RongJie Bio Process（Suzhou）Co.,Ltd

2016 年 11 月 17 日 广东·珠海 简介

蛋白药物制剂研究开发的重要性及挑战性现今越来越多地被生物制药行业所认同。 针对

各种蛋白药物，开发出科学、合理、稳定的制剂对生物药物真正走向市场至关重要。结合相关

技术人员对制剂研究开发的关注热点，荣捷生物工程（苏州）有限公司于上海在成功举办 2016

年首届蛋白（抗体）类药物制剂高峰论坛暨制剂配方培训班后，于 2016 年 11 月 17 日在珠海

举办“蛋白（单抗）药物制剂开发研修班”， 再次邀请 Danny Chou 博士就制剂研究开发的

多方面内容进行细致研讨与指导。

主办单位:荣捷生物工程（苏州）有限公司

时间:2016 年 11 月 17 日（09:00--17:00）

地点:广东省珠海市湾仔银湾路 1663 号华发喜来登大酒店（近国际会展中心）

联系人:蔡先生 电话：13795335351，0512-80912011 E-mail：ruicai@sunyear.net

培训费:3500（叁仟伍佰）元人民币/人

付款方式:开户银行：上海浦东发展银行苏州分行工业园区支行

账号：890 401 553 000 020 19

会议回执

我公司 将有以下人员参加本次会议！

姓 名 部 门 职 位 电 话 邮 箱

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]

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.