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肯威尔列兵有限公司:在全球范围内提供定制的生物制药解决方案
Kemwell Biopharma 是为全球制药和生物制药组织提供定制工艺、产品开发和制造解决方案的领先供应商。该公司从事该行业已有 30 多年,并已成为客户可靠的合作伙伴。
公司的使命是提供满足每个客户独特需求的高质量生物制药服务。 Kemwell Biopharma 提供广泛的服务,包括工艺开发、分析方法开发、配方开发、临床试验材料制造、商业制造和包装。
工艺开发
Kemwell Biopharma 的工艺开发团队与客户密切合作,开发满足其特定要求的高效且可扩展的工艺。团队采用最先进的设备和技术,在确保产品质量的同时优化生产流程。
分析方法开发
Kemwell Biopharma 的分析方法开发团队开发了可靠的方法来测试生物制品的质量属性。该团队使用先进的分析技术,如 HPLC、UPLC-MS/MS、ELISA 分析等,以确保结果准确。
配方开发
Kemwell Biopharma 的制剂开发团队根据客户要求为药品制剂提供定制解决方案。该团队在开发各种剂型方面拥有专业知识,例如冻干粉或液体制剂。
临床试验材料制造
Kemwell Biopharma 提供从小批量到 III 期试验所需的大批量的临床试验材料 (CTM) 制造服务。公司确保及时交付 CTM,同时严格遵守 cGMP 指南。
商业制造
Kemwell Biopharma 使用其位于印度班加罗尔的最先进设施提供商业制造服务,这些设施已获得 USFDA 和 EMA 等监管机构的批准。该公司可以生产从小分子到单克隆抗体 (mAb) 等复杂生物制品的各种产品。
包装服务
除了核心产品外,Kemwell 还提供包装服务,包括初级包装(西林瓶、注射器等)、二级包装(纸箱、标签等)和三级包装(装运箱)。
质量保证
在 Kemwel,质量保证是从原材料采购到最终放行测试的每个阶段不可或缺的一部分。质量控制部门确保在生产的所有阶段都遵守 cGMP 准则。
结论:
总之,Kemwel Pvt Ltd 是全球领先的定制生物工艺解决方案提供商。他们的专长在于提供端到端的解决方案,从流程开发、分析方法开发、配方开发、临床试验材料制造商业制造和包装服务开始。他们的对质量保证的承诺使他们在这个领域的其他参与者中脱颖而出。知道他们已经存在超过 30 年让他们相信随着时间的推移他们已经与客户建立了信任,使他们成为您可以信赖的可靠合作伙伴!