病毒样颗粒(VLPs)疫苗制造
通过可靠的扩大化优化上游生产力和澄清工艺
为了满足生产率的要求,必须对选择用于制造VLP的上游生产平台进行优化。该优化包括在用于去除细胞和细胞碎片的细胞裂解步骤之后的澄清步骤,并需要确保颗粒的稳健收获。然而,只有能够针对预期市场需求进行可靠扩大化的上游工艺才能成功。
通过稳健地去除杂质实现产量和效率目标
来自裂解细胞的核酸是VLP生产工艺常见的一种污染物。欧洲药物管理局(EMA)和世界卫生组织(WHO)允许的每剂量肠外疫苗DNA含量为10 ng,口服疫苗为100 µg。此外,为了尽可能降低宿主细胞核酸致癌性,DNA的长度大小应降至100-200碱基对。
最大限度提高下游回收率
VLP通常是通过超离进行纯化的。虽然该工艺已成熟用于小规模的生产,但它可能会较为耗时且可放大性较差。离子交换色谱等纯化方法也可作为替代方法。在某些工艺中,膜吸附和整体技术相比于颗粒基树脂可提供更好的动态结合能力(DBC)。同时采用尺寸排阻以及基于结合进行分离的多峰树脂是另一种选项。
通过无菌过滤、配制和最终填充确保患者的安全
为了确保患者的安全,最终的VLP产品必须采用0.22 µm过滤器进行无菌过滤。基于VLP的疫苗的配制可以使用一次性组分实现;含有制剂试剂的一次性袋可通过无菌快速接头与任何混合器进行相连。在完成混合和配制后,产品可无菌转移至一次性灌装系统,用于最终的灌装和分瓶。
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上游细胞培养
Maximize upstream productivity of VLPs and ensure robust scalability with:
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核酸酶处理和澄清
Achieve the desired yield of VLPs and process efficiency while ensuring robust impurity removal with:
- Nuclease treatment with Benzonase® suitable for biopharmaceutical production EMPROVE® bio
- Benzonase® Detection with Benzonase® Elisa Kit II to detect left over Benzonase® endonuclease in the process
- Primary/Secondary Clarification with Millistak+® HC POD Depth Filters
- Primary Clarification with Clarisolve® Depth Filters
- Secondary Clarification with Polysep II cartridges
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下游 - 切向流过滤
Achieve yield, efficiency and virus recovery goals while ensuring robust impurity removal with:
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下游 - 层析
- Membrane Chromatography with Eshmuno® Q Resin
- Membrane Chromatography with Natrix® Q Recon Mini Chromatography Membranes
- Membrane Chromatography with Natrix® Q Pilot Chromatography Membrane
- Capture and/or Polishing Chromatography with Fractogel® EMD DEAE Chromatography Resins
- Capture and/or Polishing Chromatography with Fractogel® EMD DMAE Chromatography Resins
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制成品无菌过滤和灌装
Ensure patient safety with reliable and robust sterile filtration, formulation and final fill.
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验证与测试服务
Our BioReliance® testing services offer exceptional, risk-mitigating solutions to help you bring life-changing drugs to market, faster.
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