细胞培养 & 基于细胞的生物测定服务

im体育APP’s comprehensive suite of cell-based bioassay services represent a complete tool kit that goes well beyond routine molecular separation and sample analysis.

Leading biopharmaceutical companies rely on im体育APP’s cell culture facility and bioassay laboratory to fortify their drug discovery and development programs. From determining candidates and making initial investment decisions to lot release and stability testing, cellular assays are critical throughout biologic drug development. Not only are reliable and accurate methods for determining drug potential and efficacy early in development essential, but cell-based bioassay development and biological assay validation must be accomplished quickly, given the highly competitive biologic industry, particularly for cell and gene therapy modalities.

Reliable potency assays are arguably the most important cell-based bioassays, as these assessments are needed to characterize the ability of a drug to drive biologic activity in accordance with the intended therapeutic function, per ICH Q6B for biological drug substances and products. Many biologic drug developers rely on CDMOs to meet bioassay demands, and a reliable and credible contract partner for your cell-based assay can be the difference between struggle and success. Leverage the experience and expertise of our team of skilled cell biologists to design cellular assays that carefully assess biologic activity to produce valuable data for product efficacy analysis, 内部决策, 以及监管程序.

Cell-based bioassay support for all stages of drug development

Confidently navigate regulatory filings and approval processes with the support of our consultative, 消息灵通的团队. im体育APP’s biologics laboratory has extensive experience working with most biologic drug modalities, 包括 肽, 单克隆抗体(mab), 蛋白质/酶, antibody-drug conjugates (ADCs), lentivirus/adeno-associated virus 基因疗法癌症疫苗、细胞疗法等等. With a dedicated BSL-2 facility and years of cell and tissue culture experience, our knowledgeable team can work with any cell type in both monolayer and suspension formats, 包括 different immortalized cell lines (such as MDCK), 主细胞, 和组织样本(如大脑), 血, 牛奶和更多).

Our end-to-end solutions support all stages of drug development from discovery, 临床前研究和临床试验, all the way to commercial manufacturing and post-market surveillance. im体育APP’s complete suite of CMC testing services include in vitro potency testing, 体外细胞摄取, MTS化验, permeability studies and large molecule characterization, as well as IND/BLA submission support and regulatory consulting. Our scientists are adept at rapidly executing stage-appropriate, custom cell-based bioassay development and validation, in addition to other more routine cellular assays to assess biologic drugs robustly and accurately, 不管形式如何, 作用机制和靶标.

全面的生物测定能力

• Potency assays: Custom bioassay development and validation per ICH guidance, 包括 biologic drug cellular uptake and cellular response to a biologic drug
• 生物测定方法优化
• 药物渗透性测定
• Cell proliferation and viability determination (MTT/MTS化验)
• 细胞因子的屏幕
• 荧光法测定报告基因
• 基因表达分析
• 细胞信号分析
• 配体结合试验
• 细胞死亡和凋亡试验
• 细胞毒性研究
• Drug target identification and isolation from tissue samples
• 生物药物特性
• 基础研究和药物发现
• 生物制剂 License Application (BLA) submission support
• 常规批量测试
• 稳定性评估中的效价测试
• 媒体资质和特征

im体育APP优势

If you need advanced characterization of biologic drug molecules, 效价分析的发展, 细胞反应数据, 批放行支持, 或更多的, im体育APP’s cell culture expertise is at your disposal. Accelerate your program by leveraging our history of success and accumulated knowledge with our “off-the-shelf” bioassay solutions for various applications, 也称为“平台方法”,” saving precious time by eliminating the need to seek out and develop assays for specific purposes from scratch. With our depth and breadth of experience supporting biologic drug development programs, we understand the challenges unique to large molecule therapies and stand ready to provide tailor-made bioassay services and experienced regulatory consulting.

F或更多的 information about im体育APP’s cell culture and cell-based bioassay services for biologic drug discovery and development programs, 或者要求报价, im体育APP 今天.