制剂和制成品灌装
确保制剂和制成品灌装成功
制剂过程存在着一系列挑战,包括需要可靠地采购低微生物含量、低内毒素的高纯度辅料,保持蛋白质稳定性并掌控高浓度蛋白质治疗剂的粘度。
我们广泛的SAFC® 制剂、无菌过滤和制成品灌装产品组合满足高风险液体应用要求,具有低内毒素和低微生物含量,可确保高质量,同时简化供应商资格鉴定复杂程度,加快您的工作流程。
制成品过滤和灌装需要无菌和高效,以确保无体积损失且可灵活处理多种产品。 一次性制成品灌装组件兼具灵活性和生产力,可满足制造各种药品和灌装量需求。
相关类别
我们的药用辅料产品组合为您提供了药品所需的一切。
我们的粘度降低平台可助您配制高浓度蛋白质的皮下制剂。
我们为生物制药制剂提供了低微生物含量、低内毒素的材料。
无菌过滤对于药物生产和生物工艺中的细菌去除至关重要。
Mobius®一次性系统可设计为配有一个或多个无菌过滤器。
健全的流体管理体系能降低工艺污染的风险。我们能通过一次性系统和多用系统为您的工艺需求提供支持。
相关资源
- Low NPI Sucrose for Biopharmaceutical Formulations
Read about a purification process resulting in low-NPI sucrose to achieve more stable protein formulations.
- Addressing Viscosity Challenges for Subcutaneous Injections
It was found that in contrast to single excipients, an amino acid and an anionic excipient can be more efficient at reducing viscosity when used in combination than when either is used alone, even at higher concentrations.
- White Paper: The Viscosity Reduction Platform: Viscosity-Reducing Excipients for Protein Formulation
Read about the effect of protein viscosity on injection force and the platform’s ability to balance viscosity reduction with protein stability.
- Parenteral Drugs: Ensuring Sterility and Minimizing Risks During Manufacturing
This article describes strategies to ensure sterility of parenteral drugs.
- Formulation Product Finder
Quickly sort our excipients and API portfolio by dosage form, application, and many other parameters.
- Risk Mitigation Tool
Get guidance through the challenges and quality requirements of your bio-manufacturing process.
- Brochure: Millipak® Final Fill Filters Reduce Contamination Risks and Simplify Filtration System Design and Operation
This tech note summarizes the results of microbial challenge studies that confirm the aseptic multipurpose port (AMPP) prevents microbial contamination entering the flow path.
- Brochure: Identifying Appropriate-Quality Raw Materials in an Evolving Regulatory Environment
Manufacturers need to ensure that the raw materials they use meet regulatory requirements and can be demonstrated to have appropriate, consistent and documented quality that mitigates risk and is traceable throughout the supply chain.
- Use of Stabilizers and Surfactants to Prevent Protein Aggregation
This article outlines critical factors in long-term stability of proteins, and manufacturing conditions and drug product handling.
相关服务
Emprove®化学品:400多种有助于药物生产简化、合规的原料。
相关网络研讨会
在本次网络研讨会中,您将了解如何在生物工艺过程中尽可能提高稳定蛋白质浓度。
本次网络研讨会将全面综述蛋白质聚集、潜在机制以及在肠外制剂中使用(新型)辅料的稳定技术。
内毒素属于哺乳动物体内的热原,因此为了确保患者的安全,应全程控制药物中的内毒素含量。了解详情。
本网络研讨会将总结此版的重要内容,并重点介绍一次性过滤系统如何有助于制定整体污染控制策略,帮助药品生产商满足监管要求。
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