原液工艺
Drug Substance Process

为了尽早开展人体试验，生物药研发者需要以最快的速度开发出一个可靠的生产工艺，以确保为临床持续提供安全、有效、高质量的药品。必须争分夺秒，每一步都不能走错，这种紧迫感会贯穿整个药物开发过程。在IND/BLA申报中，生产工艺的质量、产量、稳定性、可靠性、经济性都是非常关键的考察要素。智享团队拥有超过20个项目的工艺开发经验，其中有7个生物药成功在中国上市，我们知道如何把一个分子做成蛋白原液。我们的生物药专家会与您并肩作战，帮助您突破制药工艺盲区，把新药飞速推进临床和市场。您的成功就是我们的成功

In the race to the FIH (first-in-human) trials, biologic developers need to establish a reliable manufacturing process, ensuring continuous supply of safe, effective, and high-quality drugs, at the fastest speed. Every step needs to be on the right track and there is no time to lose. This sense of urgency continues throughout the development process. High quality, high yield, robustness, reliability, and cost effectiveness all become equally high priorities, with the process forming an essential element of IND/BLA filing. With more than 20 programs of process development experience, including 7 successful commercial biologics in China, the IntellectiveBio professionals know how to transform your discovery into a drug substance. Let the biologics experts at IntellectiveBio help you, work with you to unleash the potential of your discovery and rocket your drug to clinic and market. We are as committed to your success as you are.

上游工艺开发
Upstream Process Development

苏州智享拥有专业的上游工艺技术平台，具备全方位开发能力，包括培养基开发、细胞培养工艺开发、优化、放大和表征。

IntellectiveBio has a professional up-stream technology platform with comprehensive capabilities, including culture media development, cell culture process development, optimization, scale-up and characterization.

在早期临床阶段，速度、灵活性、专业性，对于原液工艺开发是非常关键的。我们的技术专家运用他们多年积累的技能，可显著提高批产量，缩短项目开发时间。同时，我们拥有丰富的经验和专业的能力，有信心为每一位客户开发出着眼于长远商业化生产的最佳工艺。

In early clinical phases, speed, flexibility, and expertise are critical for drug substance process development. Our experts apply their strong skills to significantly increase the batch yield and reduce processing time for your molecule. Meanwhile, we have the experience and capabilities to develop an optimal process with long-term commercial manufacturing in sight.

服务优势：
Our advantages:

  • 多种治疗性蛋白CHO细胞培养经验，涵盖单抗、融合蛋白、双抗、三抗、纳米抗体，以及其他重组蛋白

    Rich CHO cell culture experience on a very broad range of therapeutic protein types: mAbs, fusion proteins, bi-specifics, tri-specifics, nanobodies, and other recombinant proteins

  • 多种细胞培养模式选择，比如流加培养、连续灌流、高密度接种培养、浓缩型分批补料培养

    Multiple cell culture modes, including fed-batch, perfusion, high cell density inoculation, and concentrated fed-batch

  • 来自世界领先供应商的不同种类，多种规模的生物反应器可选：

    • Applikon玻璃生物反应器（3L, 7L, 15L）
    • Sartorius玻璃生物反应器（3L）
    • Xcellerex XDR一次性搅拌釜生物反应器（50L, 200L）
    • GE波浪式生物反应器（20L, 50L）
    • Kuhner摇晃式生物反应器（200L）

  • Multiple types of bioreactors with various scales from world-leading suppliers, including:

    • Applikon glass bioreactors (3L, 7L, 15L)
    • Sartorius glass bioreactors (3L)
    • Xcellerex XDR single-use stirred-tank bioreactors (50L, 200L)
    • GE wave bioreactor (20L, 50L)
    • Kuhner shaken bioreactor (200L)

  • 采用DoE实验设计进行针对性优化：培养基/补料策略、细胞密度、表达量、电荷异构、糖基化、唾液酸、蛋白纯度、宿主蛋白残留

    Design of Experiment (DoE) studies to optimize target items: media/feed strategy, cell viability, titer, charge isomerism, glycosylation, sialylation, purity, HCP residue

  • 通过建立工艺参数与关键质量属性的数学模型来定义设计空间，确保细胞培养工艺的一致性和稳健性

    Define the design space for process consistency and robustness by establishing the mathematics model between cell culture process parameters and critical quality attributes

  • 苏州智享拥有自主知识产权的培养基，并可根据客户项目特殊性进行定制培养基开发，降低生产成本

    IntellectiveBio property-owned cell culture media, and media customized development based on the specialty of our client’s project for manufacturing cost saving