原料，在制品 & 批放行测试

Release testing is a significant component of the quality control process and a critical aspect of drug development, 从早期阶段到商业批量发布, 确保生物制药原料药, 药物产品, 原材料, and in-process materials comply with established specifications prior to finished product release.

These established specifications are necessary to demonstrate that the product complies with applicable regulatory requirements, 包括21 CFR第210和211部分, 也是为了确认纯度, 身份, 和效力. For biologic products, 纯度, concentration, consistency, 身份, and biosafety must be 验证. im体育APP’s consultative scientists are well-versed in the interpretation of data for developing product specifications, 拥有深厚的监管指导经验, and utilize a wide range of advanced analytical technology and methodology.

原料释放试验

Any raw material or active pharmaceutical ingredient (API) is required to meet the criteria outlined in 21 CFR 211.84 before it can be used in any 制造业 process or formulation. Raw material testing confirms both the 身份 and integrity of the material, ensuring that the right product has been received and that it meets the specifications that have been established for its intended use. im体育APP’s raw material testing supports the entire drug development lifecycle, 从早期开发到商业化生产, with a comprehensive suite of services including specification and characterization testing for vendor qualification and the release of APIs and excipients used in 制造业. Our team of 原材料 testing experts make use of a wide range of advanced analytical techniques and instrumentation, 包括快速识别，如拉曼光谱, 显著缩短测试周期时间. 另外, 专著和药典方法可以验证, 现有的测试方法可以被转移, 验证, 和优化, or alternative raw material release methods can be developed and validated.

过程中和药品批放行试验

im体育APP’s comprehensive suite of quality control (QC) lot release solutions apply to all stages of 制造业, including in-process testing and pharmaceutical process validation testing (revalidation) needs that result from modifications to formulations, 新流程, 或者设备更换. Our consultative teams of expert scientists have a demonstrated track record of delivering expedient and exacting results for process validation and in-process testing, in addition to release testing in our purposefully equipped GMP laboratories. Our CMC experts design thorough quality control lot release testing programs customized to meet the individual needs and specifications of each specific biopharmaceutical product tested. Rigorous analytical testing services ensure established quality standards and GMP requirements are met prior to the release of manufactured batches of drug product. 可用时采用药典方法, new test methods can be developed and validated by our knowledgeable team, 或者现有的分析方法可以很容易地转移, 验证, 和优化.

GMP材料和批放行测试服务

• 方法开发、验证、确认和转移
• Compendial and pharmacopoeia monograph tests (USP/NF, JP, EP, FCC, BP)
• 理化分析
• 身份
• 效力和纯度
• 杂质检测
• 制定验证
• 有关物质
• 均匀性
• 可吸入颗粒物
• 极限测试
• 残余溶剂测试
• 解散测试
• 物理化学性质
• 展示(注射器和小瓶体积，辅料浓度)
• 微生物试验和化验
• 重金属
• 内毒素检验(无菌和非无菌产品)
• 容器封闭鉴定(可提取和可浸出)

可比性与生物药批放行试验

在任何生物制品可以放行使用之前, 出售, 或出口, lot release testing is necessary to demonstrate the product meets previously established specifications for 身份, 效力, 和纯度. 另外, comparability testing is needed to ensure that each new lot of product is the same as the original batch, and can identify whether any changes made to 生产流程 have resulted in downstream product quality changes. 监管机构, 包括FDA, require a series of analytical tests be performed on unprocessed and purified bulk materials for each lot of large molecule product produced, 然而, the 复杂的ity of testing required is influenced by two key factors, the product indication and the source and level of control of 原材料 used.

im体育APP’s consultative team of expert scientists have the depth of regulatory and industry knowledge to help you confidently navigate the regulatory requirements for biologic product material and release testing program design, 考虑几个因素, 包括化学复杂性, 生产流程, and the reliability and 复杂的ity of analytical methods used to evaluate the 身份, 纯度, 以及材料的效力.

生物制品材料和放行测试服务

• 可比性的测试
• 方法开发，验证，确认和转移
• Compendial and pharmacopoeia monograph tests (USP/NF, JP, EP, FCC, BP)
• 蛋白纯度及相关蛋白
• 肽图
• 杂质
• 鉴定(SDS-PAGE, Western blot，免疫测定，ELISA)
• 纯度(HPLC, SDS-PAGE，水分，内毒素，ELISA)
• 效力(免疫原性、抗原含量或化学成分)
• 蛋白质浓度
• 氨基酸分析
• 残留污染物检测
• 宿主细胞蛋白(HCPs)测定
• 细胞生物
• 物理化学性质
• 微生物试验和化验
• 不育性测试

im体育APP优势

Our regulatory and industry experts ensure every client receives the im体育APP standard of regulatory guidance that has helped countless organizations bring revolutionary small and large molecule 药物产品 and therapeutics to market, 同时满足原材料的规格和时间要求, 批或批放行, 和分布. With im体育APP as your CDMO partner throughout the drug discovery and development process, confidently meet Agency expectations with our full-service chemistry, 制造业, and controls (CMC) and QC solutions that include reference standard characterization and management , 建立在成功发展的基础上, 验证, 转移复杂的, 复杂的, 具有挑战性的分析方法.

To learn more about im体育APP’s quality control raw material and lot release testing programs for pharmaceuticals and biologics, 或者找我们的专家谈谈, im体育APP 今天.