"Single-use" concept in current trend of biomanufacturing 生物制药生产新趋势:"一次性使用"产品解决方案
Anne Zhang, Application Specialist FMT 张琳 / 液体处理技术产品应用专家 赛多利斯斯泰迪生物技术有限公司
Agenda内容
Introduction 简介
Benefit of "Single-use" concept
"一次性使用"生产方案优点 "Single-use" concept applications "一次性使用方案具体应用 Summary 总结
Agenda内容
Introduction 简介
Benefit of "Single-use" concept
"一次性使用"生产方案优点 "Single-use" concept applications "一次性使用"方案具体应用 Summary 总结
The Drivers in Bio- Pharmaceutical Processes 生物制药生产的驱动力
Safety安 全
No Cross contamination 无交叉污染
Efficiency效 率
May 2008
Speed Value benefit Process economics 速度影响工艺经济性
DifferentStarting Material Expression Systems 不同起始原料表达系统
Quality质量
Page
3
Major considerations of bioloigcals manufacturers 生物制药生产商的主要考虑

Capital investment 投资成本 Process cost 生产成本 Time to market 产品上市时间 Flexibility of facilities 生产车间灵活性 Ease of maintenance 便于维护 Safety 安全 Regulatory compliance 符合法规
Regulatory Aspects 法规要求
FDA on equipment cleaning and maintenance (Code of Federal Regulations (CFR) Part 211.67 Title 21 - Rev. 25 May 2004 Equipment and utensils shall be cleaned, maintained, and sanitized at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements. 仪器必需清洗干净, 避免交叉污染及失灵
Source: www.accessdata.fda.gov
Regulatory Aspects 法规要求
GUIDE TO INSPECTIONS VALIDATION OF CLEANING PROCESSES (FDA) FDA expects firms to have written general procedures on how cleaning processes will be validated. 清洗过程必需有记录
FDA expects firms to conduct the validation studies in accordance with the protocols and to document the results of studies. 认证档案齐全,包括过程与结果
The data should support a conclusion that residues have been reduced to an "acceptable level". 生产过程中的残留必需减少至最低可接受程度,并需有数据支持
Source: www.fda.gov/ora/insprct_ref/igs/valid.html

下一页