工艺验证方案模板

Verification department (department):

验证科室（部门）：

Verify completion date:

验证完成日期：

Validity:

有效期：

Index 目录

1.Purpose目的 (5)

2.Scope范围 (5)

3.Responsibility职责 (5)

3.1 AAA responsibilities AAA的职责 (5)

3.2 XXX responsibilities XXX的职责 (5)

4.Regulation and Guidance 法规和指南 (7)

5.Abbreviations缩略语 (8)

6.Protocol Description方案说明 (10)

7.Product And Process Description产品和工艺描述 (12)

7.1 Product specification (12)

7.2 Drug approval No. (12)

7.3 Standard Followed: (12)

7.4 Raw Materials and Adjuvants原辅料情况 (12)

7.5 Process description: (14)

7.6 Process Recipe工艺处方： (18)

7.7 List of Production Plants生产车间一览 (23)

7.8 List of Production Equipment 生产设备一览 (25)

7.9 Process Flow Diagram 工艺流程图 (28)

7.10 CPP Identification CPP确认 (28)

7.11 Validation Plan验证计划 (42)

8.Validation prerequisite验证先决条件 (44)

8.1 Personal Identification人员确认 (44)

8.2 Process Documentation Verification 生产文件确认 (44)

8.3 Training Verification 培训确认 (45)

8.4 System and Equipment Instruments Calibration Verification 系统和设备仪表校验确认.. 45

8.5 System and Equipment Instruments Calibration Verification 生产相关验证状态确认 (46)

8.6 Test Instruments Calibration Verification 测试仪器和仪表校验确认 (46)

8.7 Testing Method Validation Verification检验方法验证的确认 (46)

8.8 Raw Material and Excipient Verification原辅料确认 (47)

9.Sampling Plan and Evaluation Criteria取样计划及评估标准 (49)

10.Sample Coding Method样品编码原则 (62)

11.Process Validation Test Execution 工艺验证执行 (64)

11.1 Liquid Preparation 液体配制 (64)

11.2 Cell Resurrection and Passage细胞复苏及传代 (66)

11.3 Harvest liquid test 收获液检测 (72)

11.4 Clarification Filtration Efficacy Test 澄清过滤效果检测 (73)

11.5 UF Concentration 1 Efficacy Test超滤浓缩1效果检测 (74)

11.6 Ammonium sulfate precipitation efficacy test 硫酸铵沉淀效果检测 (75)

11.7 Potassium bromide extraction efficacy test 溴化钾提取效果检测 (76)

11.8 First density gradient centrifugation efficacy test 一次密度梯度离心效果检测 (77)

11.9 Second density gradient centrifugation efficacy test 二次密度梯度离心效果检测 (78)

11.10 UF Concentration 2 Efficacy Test 超滤浓缩2效果检测 (79)

11.11 Chromatography purification product test 层析纯化产物检测 (80)

12.Bulk Determination原液检验 (82)

13.Process Validation Summarization工艺验证总结 (83)

14.PV Report工艺验证报告 (83)

14.1 Process Validation Report 工艺验证报告 (83)

14.2 Process Validation Analysis and Evaluation 工艺验证分析与评价 (84)

15.Requirements on Execution Records 执行记录要求 (84)

16.Deviation Handling 偏差处理 (84)

17.Change Handling 变更处理 (85)

18.Test Form测试表 (86)

表格1 缩略语 (8)

表格2原辅料质量标准表 (10)

表格3物料消耗表1 (18)

表格4物料消耗表2 (18)

表格5所用液体配料表 (19)

表格6生产车间一览表 (23)

表格7主要生产设备一览表 (25)

表格8工艺风险分析表 (33)

表格9工艺时间表 (42)

表格10取样计划表 (49)

表格11样品编码原则 (62)

表格12配液取样检测信息表 (64)

表格13复苏和传代取样表 (66)

表格14复苏和传代样品编码 (72)

表格15收获液标准 (73)

表格16澄清过滤标准 (74)

表格17超滤浓缩1标准 (74)

表格18硫酸铵沉淀标准 (75)

表格19溴化钾提取标准 (76)

表格20一次密度梯度离心标准 (77)

表格21二次密度梯度离心标准 (78)

表格22超滤浓缩2标准 (79)

表格23纯化产物标准 (80)

表格24原液标准 (82)

表格25测试表列表 (86)

1. Purpose目的

This purpose of this process validation is to provide documented evidence to show that the combination of the personnel, materials, equipment, methods, environmental conditions and the other related utilities XXX Co., LTD (XXX) can ensure the consistent production of products conforming to the enterprise internal standards and the national standards, and the processes are reliable and conforming to the GMP requirements. The process validation and the test results are to be documented based on this validation protocol.

本工艺验证用于提供文件化的证据，证明XXX疫苗一室生产XXX原液的人员、材料、设备、方法、环境条件以及其它有关公用设施的组合可以始终如一的生产出符合企业内控标准及国家法定标准的产品，工艺稳定可靠，符合GMP要求，工艺验证的过程和检查的结果将按照该验证方案进行记录。

2. Scope范围

This protocol is applicable to the process validation of XXX produced by the equipment located XXX.

本方案适用于XXX原液生产的工艺验证。

由于工作细胞库制备的过程并非常规生产过程，因此，不在本次验证中进行考察。

The labeling and packaging processes are not within the scope of this document since these processes have been validated per PQ protocol (labeling) and PQ protocol (packaging), and these processes have minimal impact on finished product quality.

贴标签和包装也不在此文件范围内，因为这些工艺已经按照PQ方案（贴标签）和PQ方案(包装)验证过，并且这些工艺对产品质量极少有影响。

3. Responsibility职责

3.1 AAA responsibilities AAA的职责

✓Compile Protocol

方案的编写

✓Guide Protocol execution, data collection/ Provide test data for review upon request by customer

指导方案的实施，数据的收集/在客户要求时提供测试数据供其审核

✓Final report Review/ Analyze and compile data into the summary report

最终报告的审核/对数据进行分析并将其编辑入总结报告之中

3.2 XXX responsibilities XXX的职责

⏹Production department 生产部

✓Review and approve protocol

审核并批准验证方案

✓Assure all the equipment used for validation can be maintained timely 保证验证用所有设备均能按SOP进行及时的维护和保养

✓Assure all the raw materials used for validation can be supplied timely and comply with domestic quality criteria of enterprise

保证验证用原辅包装材料能按时到货，并符合企业内控标准

⏹Research and development department 研发部

✓Provide product registration criteria and review whether recipe and process step described in the protocol is complying with registered criteria

提供产品的注册工艺，审核方案中生产处方、工艺与注册资料的一致性

✓Review and make assurance the compliance of raw material supplier with registered supplier

审核原辅料供应商和注册资料的一致性

✓Review relevant quality criteria including raw material, intermedia and finished product 审核原辅料标准、中控质量标准和成品的质量标准

⏹Vaccine one Plant 疫苗一室

✓Coordination and implementation of this validation protocol

协调、实施本验证方案

✓Training of personnel based on this validation protocol

按验证方案对有关人员进行培训

✓Collection, sorting and reviewing of validation data and drafting of validation reports (including the deviation report, if there are any deviations)

收集、整理和审核验证数据，起草验证报告（如方案执行有偏差，要完成偏差报告）。⏹Utility support department 工程服务部

✓Assistance in implementation of this validation protocol

协助本验证方案的实施

✓Calibration of instruments related to this validation protocol and providing relevant calibration certificates and quality certificates

负责校验和本验证方案有关的仪器、仪表，出具校验报告并贴合格证

✓Assure normal operation of the utility system

保证公用系统的正常运行

✓Final report Review

最终报告的审核

⏹Quality control of quality department 质量部质量控制

✓Determination of test methods used in this validation protocol

负责确定本验证方案的检验方法

✓Validation of the necessary test methods for XXXXX involved in this validation protocol

负责本验证方案涉及的重组乙型肝炎疫苗（CHO细胞）原液生产的必要的检验方法的验

证

✓The quality inspections on XXXXX Tablet involved in this validation protocol, and presenting full item certificates of analysis and quality inspection reports and records

负责本验证方案涉及的重组乙型肝炎疫苗（CHO细胞）原液生产的质量检验，并出具全

项检验报告，提供质量检验报告书及检验记录

✓Providing technical supports and guidance for tests at each of the process steps 负责各工序检验的技术支持和指导

✓Coordinating the plant in the implementation of this validation protocol

协同车间实施本验证方案

✓Final report Review

最终报告的审核

⏹Quality assurance of quality department 质量部质量保证

✓Supervision of validation process, review and approval of this protocol, and ensuring the implementation following this protocol

负责验证过程监督，方案的审核与批准，确保按批准的方案执行

✓Sampling at each process steps during the process validation

负责工艺验证中各工序的取样

✓Coordination among different departments involved in the validation activities 负责验证涉及到的各部门之间的协调

✓Providing equipment validation reports related to this validation protocol

负责提供和本验证方案有关的设备验证报告

✓Identification, audit and assessment of suppliers

供应商的确认、审计及评价

✓Assessment and handling of changes and deviations occur during this process validation

负责对工艺验证实施过程中出现的变更和偏差的评价和处理

✓Final report Review

最终报告的审核

4. Regulation and Guidance法规和指南

✓EudraLex Volume 4 EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use, November, 2008

EudraLex 第四卷欧盟药品生产质量管理规范指南医药产品人用及兽用，2008年11月✓Final Version of Annex 15 to the EU Guide to Good Manufacturing Practice : Qualification and Validation , September 2001

EudraLex 第四卷药品生产质量管理规范，附录15 验证与确认，2001年9月

✓EMEA - Note for guidance on process validation, September 2001

欧洲药品管理局–工艺验证指南，2001年9月

✓EMEA - Annex II to note for guidance on process validation, January 2005

欧洲药品管理局–附录II 工艺验证指南

✓FDA 21 Code of Federal Regulations, Part 211, current Good Manufacturing Practice for Finished Pharmaceuticals, April 2011

FDA联邦法典第21篇第211部分，现行药物制剂生产质量管理规范，2011年4月✓FDA Process Validation: General Principles and Practices , January 2011

FDA工艺验证：一般原则和实践，2011年01月

✓SFDA Good Manufacturing Practice (2010 Revision), March, 2011

SFDA 药品生产质量管理规范（2010年修订），2011年03月

✓PIC PIC/S Pharmaceutical Inspection Convention, Pharmaceutical Inspection Co-operation Scheme, “Recommendations on Validation Master Plan, Installation and Operational

Qualification, Non-sterile Process Validation, Cleaning Validation”, July 2004

PIC/S药品监管公约，药品监管合作计划，“有关验证主计划、安装和运行确认、非无菌工艺

验证、清洁验证的建议”，2004年7月

✓ A WHO Guide to good manufacturing practice(GMP) requirements , Part 2 Validation , 1997 WHO 关于GMP要求的指南，第二部分：验证，1997年

✓Chinese Pharmacopoeia (CP) 2010 Edition

中国药典（CP）2010年版

✓Process Validation of Protein Manufacturing (T echnical Report No. 42 Supplement Vol. 59, No. S-4 September/October 2005 © 2005 by PDA)

蛋白生产的工艺验证（技术报告42，PDA，2005年版）

5. Abbreviations缩略语

The abbreviations which will be used in this protocol are listed in the following form.

在下面的表格中规定了本方案中使用的缩略语。

表格1 缩略语

6. Protocol Description方案说明

⏹Using this defined process validation shall be performed for the results of the Process Risk

Assessment.

本方案实施的工艺验证，是基于工艺风险评估结果的。

⏹Using this defined process validation shall be performed for three consecutive successful

runs based on GMP requirements to demonstrate the process control reliability and the repeatability.

鉴于XXX的生产已经有近20年历史，本次验证仅是对生产地址发生变更后且主要设备未发生变化的再验证，考虑到本产品生产周期长（总生产周期为158天）的原因，本方案实施的工艺验证将生产1批成功的产品以证明其可靠性。

⏹The determination of the intermediate and final product will implement enterprise internal

standard but release finished product should be in accordance with criteria of the item “XXX”

in Chinese Pharmacopoeia 2010 Edition.

⏹半成品、成品按企业内控标准检验，成品发放按中国药典2010版三部“XXX ”标准执行

Raw material internal standard原辅料内控标准：

表格2原辅料质量标准表

XXX中间品质量标准，包括细胞收获液、纯化产物、原液（文件号：XXX）

Final product of XXX standard

XXX成品质量标准：（文件号：XXX）

⏹The validation procedures, items and contents are divided based on the system process

steps. The process steps, validation items, sampling methods, testing methods and acceptance criteria are described for each of the process steps.

验证的程序、项目和内容中以系统工序为单位，对各工序中的所涉及的工艺步骤、验证项目、取样方法、检验方法和接受标准进行了规定和描述。

⏹The process recipe of Bulk of XXX (Registration batch No.: for 20μg: GUOYAOZHUNZI XXX,

and for 10μg GUOYAOZHUNZI XXX) is briefly described in this protocol. The contents of the recipe are described and the process flow diagram is listed. The process procedure is conformed to the registration standard.

本方案对XXX原液的工艺处方（注册批号：20μg：国药准字XXX、10μg：国药准字XXX）进行了简介，对处方内容进行描述，并且列出直观化的工艺流程图。工艺规程与注册标准一致。

⏹This protocol is used to specify the purpose and the scope of this validation and the

responsibilities of each of the departments during the implementation of this validation protocol.

本方案旨在指明验证的目的、范围，并规定了该验证方案在实施过程中的各部门的职责。

⏹Summarize and evaluate the entire process validation based on the validation of each of the

process steps and record the evaluation results to the report.

在各工序验证的基础上，对整个工艺验证进行了总结评价，评价结果记录到验证报告中。

7. Product And Process Description产品和工艺描述

7.1 Product specification

(1) Ampoule, one human dose of 1.0ml, containing 10μg of HBsAg

(1) 安瓿瓶，每1次人用剂量为1.0ml，含HBsAg 10μg；

(2) Ampoule, one human dose of 1.0ml, containing 20μg of HBsAg

(2) 安瓿瓶，每1次人用剂量为1.0ml，含HBsAg 20μg；

(3) Vial, one human dose of 1.0ml, containing 20μg of HBsAg

(3) 西林瓶，每1次人用剂量为1.0ml，含HBsAg 20μg；

(4) Vial, one human dose of 0.5ml, containing 10μg of HBsAg

(4) 西林瓶，每1次人用剂量为0.5ml，含HBsAg 10μg。

7.2 Drug approval No.

20μg：GUOYAOZHUNZI S1*******

20μg：国药准字S1*******

10μg：GUOYAOZHUNZI S1*******

10μg：国药准字S1*******

7.3 Standard Followed:

Chinese Pharmacopoeia 2010 Edition

执行标准：中国药典2010版

7.4 Raw Materials and Adjuvants原辅料情况

Table 3 Raw Materials and Adjuvants

表格4原辅料信息表

7.5 Process description:

工艺简述：

Process Cycle 工艺周期

Table 5 Process Schedule

表格6工艺时间表

Take 1 to 2 tubes of cells from the working cell bank (of a same batch No.), resurrect, mix and inoculate them into a 100ml cell cultivation bottle in a ratio of 1:1. After the cells have grown full and adhering to the wall to a single layer, perform the 0.25% trypsin digestion and passage. And then inoculate them into a 100ml cell cultivation bottle in a ratio of 1:4. Passage and proliferate following the sequence of 100ml cell cultivation bottle, Kolle flask and the rotary bottle. The ratio is determined according to different cell cultivation bottle specifications. Two 100ml cell cultivation bottles are used for the passage to 1 Kolle flask. One Kolle flask is used for the passage to 1 3L rotary bottle. One 3L rotary bottle is used for the passage to 7 to 8 3L rotary bottles. One 3L rotary bottle is used for the passage to 1 15L rotary bottle. One 15L rotary bottle is used for the passage to 7 to 8 15L rotary bottles. Incubate them while the bottles are kept still or rotated at 36±1℃(the 100ml cell cultivation bottles are kept still during incubation and rotary bottles are rotated). The duration of each expansion incubation step is 5 to 7 days. After proliferated to generation No. 32, the change solution is maintained.

取工作细胞库细胞1～2支（同一批号），复苏混合后按1：1比例接种100ml细胞培养瓶，待细胞贴壁长满至单层后，0.25%胰蛋白酶消化传代，按1：4比例接种100ml细胞培养瓶。按100ml细胞培养瓶→克氏瓶→转瓶传代扩增，比例根据不同规格细胞培养瓶而定，2个100ml 细胞培养瓶传1个克氏瓶；1个克氏瓶传1个3L转瓶；一个3L转瓶传7～8个3L转瓶；一个3L转瓶传1个15L转瓶；1个15L转瓶传7～8个15L转瓶。置36±1℃条件下，采用静止或旋转培养（100ml细胞培养瓶和克氏瓶采用静止培养，转瓶采用旋转培养法）。每次扩增培养时间为5～7天，传代扩增至32代，开始维持换液。

Incubation media培养液

The growth media used for cell passage and proliferation is DMEM solution containing 9% to 10% inactivated new born bovine serum with a final concentration of methotrexate of 10-6mol/L and L-glutamine of 2mmol/L. The maintenance solution is DMEM solution containing 3% to 5% inactivated new born bovine serum.

细胞传代扩增用生长液为含有9%～10%灭能新生牛血清的DMEM液，其中含终浓度为10-6mol/L氨甲喋呤、2mmol/L L-谷氨酰胺。维持液为含有3%～5%灭能新生牛血清的DMEM 液。

Harvesting收获

After passage to the No. 32 generation and the cells have grown into a compact single layer adhering to the wall (Day 5 to 7), discard the growth liquor, add the maintenance solution, discard the incubation liquor 48 hours later and add the maintenance solution. Replace the maintenance solution every 48 hours thereafter and harvest the incubation liquor. Measure the HBsAg content in the harvested supernatant with ELISA (or reverse hemagglutination method), the result shall be above 1.0mg/L (RPHA titer 1:128). At the same time a sterility test shall be performed for the harvested solution of each bottle. The number of harvesting for a same batch of production cells shall be 19 to 21 (20±1) and the harvest solution of 1 to 2 batches can be combined for purification.

传代扩增至32代的细胞贴壁长成致密单层后（5～7天），弃去生长液，加入维持液，48小时后弃去培养液，加入维持液。此后，每48小时更换一次维持液，并收获培养液。收获的培养上清液采用ELISA法(或反向血凝法)检测HBsAg含量，应在1.0mg/L(RPHA滴度1：128)以上，同时每瓶细胞培养收获液应进行无菌检查，同一批生产细胞收液次数应达到19～21（20±1）次，每1～2批收获液可合并纯化。

Purification纯化

◆Filtration过滤

The harvested culture media go first through a 0.8μm filter and then a 0.2μm filter to remove any cell residues.

收获的培养液通过0.8μm，然后通过0.2μm滤柱，过滤去除细胞碎片。

The filtrate goes through a filter that can retain molecules of 100KD and above. Then it is concentrated 3 to 5 times through UF.

滤液通过截留分子量100KD的滤柱，超滤浓缩至3～5倍。

◆Ammonium sulfate precipitation 硫酸铵沉淀

After UF concentration, 312g of ammonium sulfate is added to each liter of the obtained culture media. It is then allowed to stand at room temperature for 4 to 5 days after stirring to allow HBsAg to precipitate.

超滤浓缩后的培养液每升加入312g硫酸铵，搅拌均匀后，室温放置4～5天，使HBsAg沉淀。

◆Potassium bromide extraction溴化钾提取

The precipitation solution is centrifuged for 30min at 4000r/min. The supernatant is discarded. The precipitates are sufficiently dissolved after adding potassium bromide powder (4.5 to 5.5g of potassium bromide is added to each liter of the harvest solution). Then 50% potassium bromide is used for the extraction of HBsAg.

沉淀液4000r/min离心30min，弃上清，沉淀中加入溴化钾固体粉末充分溶解（每升收获液加4.5～5.5g溴化钾），再用50%溴化钾溶液提取HBsAg。

◆Potassium bromide density gradient centrifugation (twice) 溴化钾密度梯度离心（两

次）

HBsAg is separated with two potassium bromide density gradient centrifugations. The density ratios of the two density gradient centrifugation were both:

采用两次溴化钾密度梯度离心HBsAg，两次离心时密度梯度液的比重均为：

Solution A:1.04g/ml sodium chloride solution

A液:1.04g/ml的氯化钠溶液；

Solution B: 1.28g/ml sodium bromide solution

B液:1.28g/ml的溴化钾溶液；

Solution C: 1.32g/ml test substance

C液:1.32g/ml的供试品；

Solution D: 1.34g/ml sodium bromide solution

D液:1.34g/ml的溴化钾溶液。

Inject the samples following the sequence of solution A, solution B, solution C and solution D. The speed of the centrifuge is 2000rpm both at the time of sample injection and at the time of sample collection. The centrifugation is performed at a speed o 25000rpm for 22 hours. HBsAg peaks are collected according to the UV absorbance value at 280nm. The HBsAg peak is peak B. The same method is used for the collection of HBsAg for the two potassium bromide density gradient centrifugation.

按A液、B液、C液、D液的顺序依次上样，上样和收样时离心机的转速均为每分钟2000转。以每分钟25000转的转速离心22小时，根据波长为280nm的紫外吸光度值收集HBsAg峰。HBsAg峰为B峰。两次溴化钾密度梯度离心收集HBsAg的方法相同。

◆Column chromatography 柱色谱

The samples collected through the two density gradient centrifugation are filtered through a UF membrane that can retain molecules of 100KD to concentrate it (for 4 to 5 times). And 20mmol/L phosphate buffer solution with a pH value of 7.0 is used for washing. Sepharose 4 FF gel filtration and chromatography are performed for the concentrated samples. The sample injection amount is 4% to 6% of the column volume. The mobile phase is 20mmol/L phosphate buffer solution with a pH value of 7.0, the elution speed is 480ml/h and HBsAg peaks are collected according to a UV absorbance value at 280nm. The HBsAg peak is peak B. The liquid collected after sterile filtration is the purified product.

二次密度梯度离心收集样品通过截留分子量100KD的超滤膜超滤浓缩（4～5倍），并用pH 7.0的20mmol/L 磷酸盐缓冲液进行冲洗。浓缩样品进行Sepharose 4 FF凝胶过滤层析，上样量

为柱体积的4%～6%，流动相为pH 7.0的20mmol/L 磷酸盐缓冲液，洗脱流速为480ml/h，根据波长为280nm的紫外吸光度值收集HBsAg峰。HBsAg峰为B峰。经除菌过滤后收集的液体即为纯化产物。

Formaldehyde treatment 甲醛处理

Add 5% formaldehyde solution to the HBsAg purified product. The final concentration of formaldehyde is 200μg/ml. Maintain the temperature at 36℃±1℃for 72 hours.

向HBsAg纯化产物中加入5%甲醛溶液，甲醛终浓度为200μg/ml，置36℃±1℃保温72小时。

Sterilization of Purified Product 纯化产物除菌

After acceptable results are obtained, HBsAg purified products from a same cell digestion batch are combined. And the bulk is obtained after UF, con centration and 0.2μm sterile filtration.

同一细胞消化批来源的HBsAg纯化产物检定合格后合并，经超滤、浓缩、0.2μm除菌过滤后即为原液。

7.6 Process Recipe工艺处方：

Major Recipe主处方：

Materials consumed for the production of 1000 units of vaccines (1.0ml/vial):

按生产1000支疫苗(1.0ml/瓶) 计算，所消耗物料量为：

Table 7 Material Consumption Table 1

表格8物料消耗表1

按生产1000支疫苗(0.5ml/瓶) 计算，所消耗物料量为：

Table 9 Material Consumption Table 2

表格10物料消耗表2

规格为10μg/支的疫苗含乙型肝炎病毒表面抗原为13200μg；

The HBsAg contained in a 20μg/unit vaccine is 24200μg.

规格为20μg/支的疫苗含乙型肝炎病毒表面抗原为24200μg。

The contents of merthiolate and residual bovine serum protein conform to requirements in Volume III of CP 2010.

硫柳汞含量、牛血清白蛋白残留量等符合《中华人民共和国药典》2010版三部要求。

For the consumption of DMEM, 1337.5g DMEM is used for the preparation of each 1000L DMEM culture media.

DMEM用量折算：每配制1000L DMEM培养液需用1337.5g DMEM。

For the consumption of aluminum chloride, it = aluminum hydroxide consumption ×241.43÷78. 氯化铝用量折算：氯化铝用量=氢氧化铝用量×241.43÷78

Table 11 Liquid Material Consumption Table

表格12所用液体配料表

3％DMEM culture media

3％DMEM培养液

133.75g

DMEM powder

DMEM粉末

0.1g

Glycine

甘氨酸

0.35g

L-Proline

L-脯氨酸

37g

Sodium bicarbonate

powder

碳酸氢钠粉末

Water For Injection

至10L 注射用水

New born bovine

3％serum

新生牛血清

10L Total

总计

4％DMEM culture media

4％DMEM培养液

DMEM powder

133.75g DMEM粉末

0.1g Glycine

甘氨酸

0.35g

L-Proline

L-脯氨酸

37g Sodium bicarbonate

powder

碳酸氢钠粉末

Water For Injection

至10 注射用水

New born bovine

4％serum

新生牛血清

Total

10L

总计

5％DMEM culture media

5％DMEM培养液

DMEM powder

133.75g DMEM粉末

Glycine

0.1g

甘氨酸

L-Proline

0.35g

L-脯氨酸

3 g Sodium bicarbonate

powder

碳酸氢钠粉末

Water For Injection

至10L 注射用水

New born bovine

5％serum

新生牛血清

Total

10L

总计

10％DMEM culture media

10％DMEM培养液

DMEM powder

133.75g DMEM粉末

0.1g Glycine

甘氨酸

0.35g

L-Proline

L-脯氨酸

37 Sodium bicarbonate

powder