药品和生物制品ICH稳定性试验

Ensure the success of your stability program with im体育APP as your experienced CDMO partner, 我们有多种灵活的储存条件, 有效的项目管理, 强大的分析测试能力, and in-depth understanding of the current regulatory landscape.

Stability testing is an integral part of im体育APP’s comprehensive suite of CMC support services, and our expertise extends from method development and validation to clinical stability and release testing. Stability studies are an essential component of regulatory submissions, and are performed throughout the product development life cycle, typically starting at the preclinical stage of drug development, 继续进行i - III期临床试验. Stability studies are a fundamental part of post-approval studies, and stability testing of market batches must be conducted regularly after product launch and the implementation of any post-approval changes.

im体育APP offers stability testing in compliance with International Conference on Harmonization (ICH) Q1A-F requirements for IND, FDA监管的人用药品的ANDA和NDA批准, with extensive experience in the design and execution of stability testing programs per ICH Q5C requirements for biotechnological and biological drugs, in addition to NADA approvals for Veterinary International Conference on Harmonization (VICH). We also offer storage conditions and protocols according to ICH stability requirements based on specific Zone designations. Your national and regional regulatory needs will be met with our phase-appropriate stability study protocols and programs tailored to your specific drug substance and drug product.

药物稳定性试验

作为CDMO战略合作伙伴, our consultative teams of scientists work alongside clients to develop comprehensive stability programs for drug substances and products that include the characterization of impurities, 降解, 以及物理化学特性的变化, 比如溶解谱, 解体, 固体剂量产品的易碎性, in addition to rheology and viscosities of topical formulations. 稳定舱, equipped with 24/7 automated monitoring and back-up generators, 支持广泛的环境, 中间, 加速, 以及长期储存条件. Commercial stability studies can be supported with cGMP storage conditions relevant to expiration dating of drug products.

生物制剂稳定性测试

Large molecule drug products are particularly sensitive to environmental factors and, 与小分子药物相比, require more complex analytical and bioanalytical methods to evaluate their quality. 由于批次间的可变性, 专门的储存条件, 以及生物药物配方的复杂性, stability testing programs may require customization for specific products to ensure they are fit for use. 因此, a wide range of justified and validated complex analytical methods and instrumentation may be needed to determine stability.

With an increased focus on particulate matter in biopharmaceuticals, along with unpredictable degradation pathways that vary with different proteins, understanding degradation routes is necessary to determine which critical quality attributes (CQAs) are most vulnerable to change throughout the product life cycle. With proven expertise and success in conducting forced degradation, 加速, short and 长期稳定 studies for a wide range of biologic modalities, 包括蛋白质, 生物仿制药, 抗体, 和更多的, our teams of knowledgeable scientists can help to establish CQAs.

利用我们广泛的现有库, robust platform methods that have been developed for a broad range of matrices to quantify product and process impurities and evaluate the quality of biologics.

im体育APP优势

Our consultative team has the depth of regulatory and scientific knowledge necessary to help small and large molecule drug developers design a reliable and effective CMC strategy, including the preparation of an effective CMC section of a regulatory submission containing stability data. Enhance the quality and efficiency of your regulatory filing and meet Agency expectations with im体育APP as your CDMO partner throughout the entire drug discovery and development process. With a proven track record of providing comprehensive and complete CMC support for successful regulatory applications, our commitment to applying our scientific expertise is evident.

To learn more about im体育APP’s stability programs for pharmaceuticals and biologics, 或者找我们的专家谈谈, im体育APP 今天.