CDMO

Contract Development and Manufacturing Organization
北极星药业(瓦卡维尔)Polaris Pharmaceuticals - Vacaville

完整的最先进的生物制药生产设施。 我们在内部执行从细胞库生产到填充和完成的所有制造过程。 我们在质量控制和质量保证方面拥有广泛的内部能力,以确保药品生产过程中的合规性丶一致性丶质量和安全性。
Polaris团队在生成基於大肠杆菌的表达和纯化系统方面有丰富的经验,可用於重组蛋白的高水平表达。小规模的开发和优化是在摇瓶和5L工艺开发发酵罐中进行的。GMP生产是在200L发酵罐中进行的。
我们设计并实施与开发阶段相匹配的客户特定流程,并考虑到商业可行性和产品生命周期。开发和临床前活动作为非GMP研究来执行。早期的临床生产由合格的方法和工艺支持,遵循cGMP准则和惯例。
我们灵活的方法和利用适合阶段的活动,为早期阶段节省了成本,同时提供了必要的全面监管支持的合规性保证,为进一步成功推进项目进入後期阶段和商业化cGMP生产奠定了基础。

Process Development

We offer a full suite of development services for biologics derived in microbial hosts using small scale fermentors, centrifuges, microfluidizers and chromatography systems.

  • Upstream process optimization up to 5L scale
  • Downstream process optimization
  • Process scalability testing

Fermentation

Our team has expertise in all microbial processes including cell bank generation, fermentation, harvest, and cell lysis. They are especially accomplished in the area of proficiency in inclusion body refolding.

    • Separate Area for Upstream Manufacturing
    • 200L Stainless Steel (Working Volume) Fermentor
    • Alfa Laval Centrifuge
    • Microfluidics 7125-20K Microfluidizer
    • 5 x 200L Harvest and Holding vessels
    • 20L to 500L Single Use Buffer Preparation Tanks
    • Buffer and Media prep

Purification

Our team has expertise in chromatography and UF/DF. We are especially accomplished in manufacturing pegylated proteins.

  • Separate Downstream Manufacturing Area
  • 3 Chromatography Skids
  • Tangential Flow Filtration (TFF) Systems
  • Dedicated Column Packing Area
  • 20L – 2000L Single Use Buffer Preparation Tanks

Fill Finish

We offer exceptional fill-finish operations and can provide all necessary elements needed to deliver high-quality parental products for clinical needs.

  • Fill-Finish operation in an ISO 5 Environment
  • cGMP compliant Fill-Finish Suite
  • Bosch FLT Filling Machine in an Active RABS Enclosure
  • In-house Visual Inspection and Labeling
  • Up to 10,000 vials per batch filling capacity

Quality Assurance

We produce drug products following Current Good Manufacturing Practices. We have an experienced Quality Assurance Team that is committed to complying with all appropriate regulations. Our team is efficient and experienced in the release of drug product components, intermediates, and final products.

Quality Control

We have a comprehensive QC team with the ability to perform most Quality Control testing on site.

Quality Control Analytics Team
  • Analytical method development capabilities
  • 5 High Performance Liquid Chromatography Machines
  • Process intermediate microbial property testing abilities.
  • Ability to test microbiological properties of process intermediates
  • Ability to perform stability testing
  • Ability to perform testing for product strength, potency, identity, purity, and safety
Microbiological Testing
  • Ability to effectively monitor the quality of manufacturing areas and utility systems
  • Ability to test microbiological properties of process intermediates
Stability Testing
  • Stability storage at multiple temperatures and time points
  • Continuous chamber monitoring and emergency power system

Facility

Our state-of-the-art facility is 7,500 ft2 of manufacturing space with a 28,000 ft2 total footprint. Our facility consists of two manufacturing trains, 2 QC labs, 2 PD labs, a warehouse, offices, and utility rooms. Our clean and plant utilities are validated and routinely tested supporting manufacturing and laboratory areas.

  • Purified Water (PW) and Water for Injection (WFI) Generation
  • Clean Dry Air Generation
  • In-House Oxygen Generation
  • In-House Nitrogen Generation
  • Automated Clean-In-Place Skids
  • Cooling water and Plant Steam Generation
  • Emergency electrical Generator

Warehouse

All final product and raw materials are stored in our temperature-controlled and access-controlled warehouse. Inventory is tracked in our electronic inventory tracking system for proper traceability and accountability. Final product storage is validated and backed up by our emergency backup system.

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