研发

R&D


专业201509061128192819的医药研发团队,一流的设备设施,让汉维成为国内第一个按照EU GLP 标准建立和运行的宠物药品研发实验室。多项新药证书、多项制剂专利授权是汉维领先、专业的宠物药品研发实力的佐证。

汉维研发团队在产品开发过程中充分的从满足客户需求、方便客户使用的角度出发,在专业医药研发的基础上,研发出一批安全、有效,并且使用、保存方便,依从性高的新药产品,并不断推陈出新,持续地为宠物健康市场提供专业的、应用性强的解决方案。

  研发工作包括:

    o 制剂处方开发
    o 分析方法开发、验证
    o 小试、中试生产性研究
    o 稳定性试验研究


The professional R&D team, and the state-of-the-art facility, make Hanvet to be the first veterinary formulation development laboratory in China according to EU GLP guideline.So far Hanvet has been granted many New Drug Certificates and authorized Patents.
Hanvet R&D activity includes:
Full range of service modules aiming to provide "one-stop shop" formulation services to meet customers' development needs at various stages.
Pre-formulation:
o Physical pharmacy profiles: solubility and viscosity in lipids, surfactants/polymers, partition coefficient (logP, logD), solid state characterization, pH, solid state stability, solution stability;
o Polymorph screening;
o Salt form selection; 
o Powder characterization: particle size evaluation and specification recommendation;
o Drug excipients compatibility;
o Formulation pre-designing;
Formulation development:
o Formulation screening using stress study and stability study;
o Process selection based on physicochemical and physical properties of the drug candidate;
o Containers, storage and shipping conditions for development candidates;
o Tech transfer of formulation and manufacturing process to clinical supply manufacturing sites;
Analytical development:
o Develop and validate analytical testing method, assay and impurity;
o Establish product specifications based on pre-formulation and formulation data;
o Support stability testing of prototype formulation;
o Provide forced degradation profiles and elucidate degradation pathway and possible degraded products;
o GMP guided analytical development activities.