im体育APP作为您经验丰富的CDMO合作伙伴，确保您的稳定性项目取得成功, with our wide range of flexible storage conditions, effective program management, robust analytical testing capabilities, 以及对当前监管格局的深入了解.

稳定性测试是im体育APP全面CMC支持服务的一个组成部分, 我们的专业知识从方法开发和验证延伸到临床稳定性和释放测试. 稳定性研究是提交监管文件的重要组成部分, 并在整个产品开发生命周期中执行, 通常从药物开发的临床前阶段开始, continuing through Phase I-Phase III clinical trials. 稳定性研究是批准后研究的基本组成部分, 在产品上市和任何批准后变更实施后，必须定期进行市场批次的稳定性测试.

im体育APP提供符合国际协调会议(ICH) Q1A-F要求的IND稳定性测试, ANDA and NDA approvals for FDA regulated human drug products, 在设计和执行符合ICH Q5C要求的生物技术和生物药物稳定性测试程序方面具有丰富的经验, 除了NADA批准国际兽医协调会议(VICH). 我们还根据ICH稳定性要求提供基于特定区域指定的存储条件和协议. 你们国家和地区的监管需求将通过我们为你们的特定原料药和制剂量身定制的适合阶段的稳定性研究方案和程序来满足.

Pharmaceutical stability testing

As a strategic CDMO partner, 我们的科学家咨询团队与客户一起制定包括杂质表征在内的原料药和产品的全面稳定性方案, 降解, and changes in physicochemical characteristics, such as dissolution profiles, disintegration, and friability of solid-dose products, 除了流变性和局部配方的粘度. Our stability chambers, 配备24/7自动监控和备用发电机, support a wide range of ambient, intermediate, 加速, and long-term storage conditions. 商业稳定性研究可以支持与药品有效期相关的cGMP储存条件.

生物制剂 stability testing

大分子药品对环境因素特别敏感, compared to small molecule pharmaceuticals, 需要更复杂的分析和生物分析方法来评估它们的质量. Due to batch-to-batch variability, specialized storage conditions, and the complexity of biologic drug formulations, 稳定性测试程序可能需要定制特定的产品，以确保它们适合使用. Consequently, 可能需要广泛的经过验证和验证的复杂分析方法和仪器来确定稳定性.

随着人们越来越关注生物制药中的颗粒物, 随着不可预测的降解途径随着蛋白质的不同而变化, 了解退化路线对于确定哪些关键质量属性(cqa)在整个产品生命周期中最容易发生变化是必要的. 在进行强制降解方面具有公认的专业知识和成功经验, 加速, 短期和长期稳定性研究广泛的生物模式, including proteins, 生物仿制药, 抗体, 和更多的, 我们知识渊博的科学家团队可以帮助建立cqa.

Leverage our extensive library of existing, 稳健的平台方法已经开发了广泛的矩阵来量化产品和工艺杂质和评估生物制剂的质量.

The im体育APP advantage

我们的顾问团队拥有丰富的法规和科学知识，可以帮助小分子和大分子药物开发人员设计可靠有效的CMC策略, 包括准备一份包含稳定性数据的有效CMC部分. 在整个药物发现和开发过程中，im体育APP作为您的CDMO合作伙伴，提高您的监管申报的质量和效率，并满足fda的期望. 在为成功的监管申请提供全面和完整的CMC支持方面有着良好的记录, 我们致力于应用我们的科学专业知识是显而易见的.

了解更多关于im体育APP在药物和生物制剂方面的稳定性项目, or to speak with one of our experts, im体育APP 今天.

  • ICH stability testing services
  • Stability-indicating assay development, including forced degradation studies
  • 实时 & long-term stability
  • Accelerated stability
  • In-use studies
  • Beyond-use stability
  • Photostability testing to ICH guidelines
  • Formulation evaluation stability
  • Follow-up stability testing
  • Freeze-thaw stability studies
  • Stress stability testing
  • R&D stability testing
  • Identification of unknown 降解 and impurities
  • Registration batch stability testing
  • In-use stability studies
  • Finished product release
  • Sterility and microbiological assessment
  • Container-closure integrity testing
  • SDS-PAGE or CE-SDS
  • Western blot
  • Charge heterogeneity (cIEF)
  • Forced degradation studies
  • 稳定性指示色谱法和排粒径色谱法(U/HPLC)
  • Spectrophotometry
  • Peptide mapping of proteins and peptides
  • Aggregation analysis by dynamic light scattering (DLS)
  • Total protein quantification by BCA or A280
  • Glycosylation studies
  • Post-translational modifications (PTM)
  • Purity assays
  • Cell-based bioassays and in vitro enzymatic activity assays
  • pH, osmolality, dissolution, and appearance
  • Subvisible particulates and moisture content
  • Active ingredient determination
  • Container-closure integrity
  • Endotoxin, microbial enumeration and sterility testing
  • Cryogenic freezers
  • 25˚C / 60% RH
  • 30˚C / 65% RH
  • 40˚C / 75% RH
  • 30˚C
  • 2-8˚C
  • -20˚C
  • <-60˚C
  • 351(a)创新生物制剂的生物制剂许可申请(BLA)
  • 351(k) Pathway for 生物仿制药 and interchangeable biologics
  • NDA (New drug application)
  • 505(b)(1) Investigational new drug (IND) application
  • 505 (b)(2) New chemical entity (NCE) pathway
  • 505(j) Abbreviated new drug product (ANDA) for generic drugs
  • OTC (Monograph-based or IND-based)
  • INAD (Investigational new animal drug)
  • NADA (New animal drug application)
  • ANANDA(仿制新动物药物的缩写新动物药物途径)
  • CNADA (Conditional approval for new animal drugs)
Pharmaceutical CMC Bottles

CMC 产品 Development Services

我们的CMC产品开发服务包括配方开发, parenteral and topical product development, microbiology testing services, and consultancy.

im体育官方app下载
Connect with im体育APP Life Sciences.

化学，制造和控制(CMC)咨询服务

We provide consulting services for Chemistry, Manufacturing, 制药和生物技术im体育平台app下载的产品开发和控制(CMC).

im体育官方app下载
Pharmaceutical 测试 scientific equipment

Forced Degradation Studies

im体育APP’s forced degradation, 根据ICH Q1A指南的压力测试服务评估对纯度有影响的原料药或制剂的稳定性, 效力, and patient safety.

im体育官方app下载
Photostability testing

ICH Photostability 测试 of Pharmaceuticals & 生物制剂

im体育APP的CMC专家提供GMPO ICH Q1B光稳定性测试，光降解研究 & light exposure tests of large and small molecule drugs. 

im体育官方app下载

Our team of over 9,000 Engaged Experts in North America, 欧洲, The Middle East, 澳大利亚, Asia and Africa are ready to help you.

Make an inquiry 今天