Expert Contract Development and Manufacturing Services

im体育APP’s fully integrated, 全面的合同开发服务支持从早期发现到生产的各种生物治疗模式和小分子药物的药物开发项目, post-approval and life cycle management.

我们的专家将与您合作支持包括抗体-药物偶联物(adc)在内的项目。, 肽, monoclonal antibodies (mAbs), recombinant proteins/enzymes, protein complexes, lentivirus/adeno-associated virus gene therapies, cell therapies, oligonucleotides, other biologics including novel formats, 小分子药物从早期发现到生产, post-approval, and life cycle management.

加快上市速度，并在im体育APP的监管和科学专家咨询团队的帮助下，成功驾驭从概念到商业化的整个药物开发生命周期. Our best-in-class, 定制解决方案是为克服开发复杂产品和独特生产过程所面临的挑战而量身定制的, including novel drug delivery systems (NDDS), compounds with bioavailability and permeability challenges, 气体tric intolerability, poor physical stability, low bioavailability, short half-life, poor solubility and difficult-to-formulate drug candidates. 我们的经验还延伸到广泛的复杂活性药物成分(api)。, including sterile APIs, 泛型, steroids and controlled substances.

Discovery services

We have a proven track record of successfully advancing discovery programs 在广泛的治疗领域的创新药物. 我们高素质和知识渊博的科学家团队提供全面的药物发现服务，包括发现化学, discovery biology, and synthetic and medicinal chemistry. 凭借我们在目标命中方面的专业知识，从概念快速推进到候选人, hit-to-lead, 并通过我们专注的图书馆平台和对起始材料的快速访问引领优化选择.

Drug substance development and manufacturing services

Our phase-appropriate drug product development services 支持活性药物成分(api)和医疗器械成分, from route scouting and selection, route comparison, route development, process research and development, process improvement and optimization, scale-up of new synthesis routes, GMP production, and manufacturing. 我们有目的地建立的生产基地支持从早期开发到小规模商业化的项目需求, delivering flexible, 个人, and cost-effective services (kilo lab). Additionally, 我们的cGMP能力是为临床试验和小规模商业原料药生产而设计的. 在我们经验丰富的团队的支持下，加快上市时间并获得有关原料药可制造性的宝贵战略见解，我们的团队拥有数十年成功解决最具挑战性的化学开发问题的经验.

大、小分子药品预制剂、制剂及工艺开发服务

im体育APP致力于为制药和生物技术公司提供一流的支持，帮助他们识别并将候选药物的合成过程转化为改进的合成过程, scaled-up processes. 我们知识渊博的配方科学家团队拥有数十年的经验，指导和加速各种剂型的小分子和大分子配方的开发和优化, in addition to providing drug substances for pre-clinical trials, clinical trials and small-scale commercial manufacturing. Bring the safest, most effective 注射用药物的, 口服, 局部, 凭借我们深厚的科学和监管专业知识，将眼科剂型迅速推向市场, 成功克服最复杂的配方挑战的良好记录, and rigorous commitment to 质量.

Clinical-scale drug product manufacturing services

im体育APP’s flexible, 阶段相适应的生产服务是为满足您药品的独特需求而量身定制的, 确保在整个药物开发生命周期内满足您的生产需求. 我们的综合全球网络处于小分子和生物药物配方和开发解决方案的最前沿. Our comprehensive suite of R&D工程和临床小规模制造解决方案支持工程测试研究, 临床, and small-scale commercial manufacturing.

Chemistry, manufacturing and controls (CMC) services

A robust chemistry, manufacturing, CMC策略在整个产品开发过程中至关重要, 从候选药物选择到批准后和产品生命周期管理. im体育APP’s diverse team of dedicated, highly qualified and experienced scientists, technical leaders, CMC regulatory specialists, 质量保证/ gmp合规培训师支持整个产品开发生命周期, providing comprehensive CMC consulting and lab services, in addition to valuable industry-specific insight. Fortify the development, clinical-scale manufacturing, regulatory submissions, 小分子和大分子药品的后审批和生命周期管理具有广泛的能力和深厚的科学, industry and regulatory knowledge.

The im体育APP advantage

With our demonstrated track record of success and dedicated, consultative team, 在im体育APP的帮助下，您可以自信而成功地驾驭整个药物开发生命周期, from discovery to post-approval and beyond. Our purpose-built facilities and robust, 质量和合规性驱动流程的设计是为了保障你们产品的质量和安全, 加快你们的治疗和生物制药产品监管申报的进度.

要了解更多关于我们的合同开发和临床制造服务和解决方案， im体育APP 今天.