In vitro diagnostic reagent raw material research and development process?

The R&D process of in vitro diagnostic reagent raw materials usually includes the following steps:

Project planning and demand analysis: firstly, the objectives and requirements of the R&D project are determined, including the required reagent types, specifications and performance requirements, and at the same time, the market demand and competition are analyzed.

raw material screening and procurement: through literature review, existing raw material library screening and laboratory testing, raw materials that meet the requirements of the project are selected. At the same time, negotiate with suppliers to purchase reagent raw materials and sign relevant contracts.

quality evaluation of raw materials: quality evaluation of purchased raw materials, including testing and verification of indicators such as appearance, purity and stability.

basic research and experimental design: design the formula of reagent raw materials according to the project requirements, optimize the composition and performance of raw materials, and determine the technological process.

laboratory research and development and optimization: the preparation and performance test of reagent raw materials are carried out on the laboratory scale, and the formula and process parameters of raw materials are optimized and adjusted to improve the stability, sensitivity and specificity of reagent raw materials.

Feasibility study: Feasibility study of the developed reagent raw materials, including cost analysis, production process verification, application effect evaluation, etc., to determine whether it meets the market demand and the feasibility of commercialization.

product development and transformation: according to the research and development results, design the production process of reagent raw materials, expand the pilot production and large-scale production process, optimize the process and debug the equipment.

product verification and registration: verify the performance of the developed reagent raw materials, including the test and evaluation of product stability, safety and effectiveness. At the same time, the registration of relevant national institutions is carried out, which is in line with relevant laws and regulations.

production expansion and marketing: expand the production scale of qualified products, establish product supply chain and distribution channels, and conduct marketing and sales.

Different R&D projects may be different, but they generally include raw material screening, formula design, laboratory R&D and production application.