制剂开发
Drug Product Development

作为一家专注于生物药的CDMO，苏州智享在生物制剂的处方开发、工艺开发方面具有广泛的经验，同时可提供满足临床前动物实验、临床试验以及商业化流通所需的不同规模的无菌制剂生产服务。

As a CDMO that specializes in biologics，IntellectiveBio has extensive experience with formulation and process development and manufacturing of sterile biological products at scales suitable for small pre-clinical animal experiments, medium clinical trials to large commercial supply.

苏州智享制剂开发团队深谙大分子药物的处方开发挑战，比如冻融不稳定、温度敏感、振荡不稳定、光敏感、低溶解度、高浓度等。我们有能力将您的分子以更快的速度和更高的效率推进到概念验证阶段，同时为商业化成功打好坚实的基础。

The drug product development team at IntellectiveBio has in-depth experience handling large molecule compounds with formulation challenges such as:

  • Freezing and thawing sensitive
  • Temperature sensitive
  • Shear sensitive
  • Light sensitive
  • Poor solubility
  • Highly potent

We are experts to take your discoveries to the proof of concept milestone with speed and efficiency while laying a firm foundation for commercial success.

处方开发
Formulation Development

苏州智享拥有分析、处方和剂型开发所需的一整套技术与解决方案，我们有充分的信心能为我们合作伙伴的分子量身定制一个精简而完整的制剂处方方案。

With comprehensive technologies and solutions to analytical, formulation and dosage form development, IntellectiveBio team is confident that we can tailor a lean, fully integrated drug formulation program precisely suited to our partner’s molecule.

我们的专家会根据您分子的生物理化特性综合考虑最终的制剂形式，确保开发出一个能使药物保持稳定的处方。标准的处方开发方案包括：

Our experts will integrate the biophysical and biochemical characterization of your molecule with the final product format, developing a formulation that will ensure the delivery of a stable product. The standard formulation development package comprises:

  • DoE处方筛选

    DoE (Design of Experiment) formulation screening

  • 稳定性研究，包括长期、加速、强制降解、光照、震荡等

    Stability studies including long-term, accelerated, stress, illumination, shake, etc.

  • 稀释相容性

    Dilution compatibility

  • 包材相容性

    Container closure compatibility

  • 为上市申请而做的详细处方参数研究

    Detailed study of formulation parameters for commercial filing

制剂工艺开发
Product Process Development

苏州智享拥有无菌灌装和冻干两种制剂生产工艺开发经验和技术平台，规格大小全面，包括ISO标准的西林瓶。我们的服务包括：

IntellectiveBio is experienced and professionalized in developing scalable product process for both sterile liquid-filled and lyophilized vials at an extensive range of sizes including ISO standard vials. Offerings including:

  • 冻融研究：放大或缩小模型

    Freeze-thaw study at scale or with scale down model

  • 混合及泵剪切力研究

    Mixing and pump-shearing studies

  • 冻干工艺开发与优化，包括预冻、退火、一次干燥、二次干燥等

    Lyophilization cycle development and optimization, including pre-freezing, annealing, primary drying, secondary drying, etc.

  • 清洁验证

    Cleaning validation

  • 无菌工艺开发与验证

    Sterilization cycle development and validation

  • 工艺可放大性研究

    Scalability studies