內(nèi)容包含如下：

1.0 INTRODUCTION

簡介

1.1 Purpose and Scope

目的和范圍

2.0 GLOSSARY OF TERMS

術(shù)語

2.1Abbreviations

縮寫

3.0 STAGE 1: BUILDINGAND CAPTURING PROCESS KNOWLEDGE — PROCESS DESIGN

第1階段：建立和收集工藝知識—工藝設計

3.1 Sequence of Activities Leading Up toStage 2 – Process Performance Qualification

進入第2階段的活動順序–工藝性能確認

3.2 Analytical Methods

分析方法

3.3 Risk Assessments

風險評估

3.4 Platform Technology Applicationduring Development

開發(fā)過程中平臺技術(shù)的應用

3.5 Quality Target Product Profile andCritical Quality Attribute Assignment

目標產(chǎn)品質(zhì)量概況和關(guān)鍵質(zhì)量屬性的分配

3.6 Control Strategy

控制策略

3.6.1 Risk Assessment to Support ControlStrategy Development

風險評估以支持控制策略的制定

3.6.2 Critical Process Parameters

關(guān)鍵工藝參數(shù)

3.6.3Noncritical Process Parameters

非關(guān)鍵工藝參數(shù)

3.6.4 Process Characterization

工藝表征

3.6.5 Criticality Assessment of RawMaterials

原材料的關(guān)鍵性評估

4.0 STAGE2: PROCESS QUALIFICATION

階段2：工藝確認

4.1 Readiness

準備

4.1.1 Equipment and Facilities

設備與設施

4.1.2 Methods

方法

4.1.3 Raw Materials

原料

4.2 Process Validation

工藝驗證

4.2.1 Process Performance Qualification

工藝性能確認

4.2.2 Process Validation Studies

工藝驗證研究

4.2.3 Validation of Single-Use Systems

一次性系統(tǒng)的驗證

5.0 STAGE 3: LIFECYCLEMANAGEMENT

階段3：生命周期管理

5.1 Ongoing Process VerificationApproaches

持續(xù)工藝確認的方法

5.2 Transfer of BiopharmaceuticalManufacturing Processes

生物制藥生產(chǎn)工藝轉(zhuǎn)移

5.2.1 Process Transfer and Adaptation

工藝轉(zhuǎn)移和調(diào)整

5.2.2 Product Comparability and Stability

產(chǎn)品可比性和穩(wěn)定性

5.2.3 Multisite Manufacturing ofBiopharmaceutical Products

生物制藥產(chǎn)品的多場所生產(chǎn)

6.0 REFERENCES

參考

7.0 APPENDIX 1:EXAMPLE OF FAILURE MODES AND EFFECTS ANALYSIS

附錄1：故障模式和影響分析的例子

8.0 APPENDIX 2:EXAMPLE OF SCALE-DOWN MODEL QUALIFICATION

附錄2：縮批模型的確認示例

9.0 APPENDIX 3: UNITOPERATIONS USED IN BIOPHARMA PROCESSES

附錄3：生物制藥工藝中使用的單元操作

9.1 Expression Construct and Cell-LineDevelopment and Characterization

表達構(gòu)建、細胞系的開發(fā)與表征

9.2 Vial Thaw and Cell Expansion (SeedTrain)

解凍和細胞擴增（種子培養(yǎng)）

9.3 Production Bioreactor(Fermentation/Cell Culture)

生產(chǎn)性生物反應器（發(fā)酵/細胞培養(yǎng)）

9.4Cell Culture

細胞培養(yǎng)

9.5 Harvest

收獲

9.6 Capture Chromatography

捕獲色譜

9.7 Viral Inactivation

病毒滅活

9.8 Polishing Chromatography

精制色譜

9.9Ultrafiltration and Diafiltration

超濾和滲濾

9.10Drug Substance Filling

原料藥灌裝

9.11Single-use Bioreactor Cell Culture

一次性生物反應器細胞培養(yǎng)

9.12Reactions

反應

9.13 Conjugation (e.g., Drug, Vaccine)

結(jié)合（例如藥物,，疫苗）