2. The Birth of a SNP Detection Kit
1. Demand research;
2. Design and optimize the reaction system;
①Screen and preliminarily determine the target site, and design primers and probes;
② Screening of suitable raw materials, such as enzyme/mix, primers, probes, etc.;
③Continuously optimize primers and probes;
3. Validation of the test kit;
4. Production process development;
5. Clinical trials and registration applications;
6. Production and marketing.
three, The "pain" points of R&D/production companies
(1) R&D team building
R&D departments are expensive to operate and often account for a significant proportion of a company's total expenditures.
(2) R&D project design
1. Screen and detect target sites and design primers and probes.
2. Screen suitable raw material suppliers in the market.
3. Continue to optimize primers and probes.
Most R&D personnel are good at product design and optimization, but may not be professional enough in raw material formulation; and most raw material suppliers usually only focus on the performance of the raw materials and find it difficult to fully consider the overall design of the test kit.
(3) Project development process
Biological experiments are fraught with uncertainty, unlike the measurable nature of physical experiments. They're more like opening a blind box. R&D projects can be delayed for a variety of reasons, and once initiated, they're difficult to pause or reverse.
(IV) Conversion of R&D projects to production
If the R&D formula is not compatible, it may make it difficult to smoothly transfer the product to production, thus delaying the time to market.
(V) Product production
Every link in the production process is crucial, and any negligence may lead to the failure of the entire production chain.
Four, Qihengxing CDMO Case
Qihengxing's R&D team not only has the R&D and production capabilities for upstream raw materials, but can also design and optimize primers and probes based on the characteristics of self-produced raw materials. Take, for example, a multi-SNP site detection kit that Qihengxing developed on behalf of a customer:
(1) Project Background
This test kit uses "SNP typing at multiple loci" (probe-based qPCR) in hospitalized patients to comprehensively assess disease risk and guide medication. Party A outsourced product development for cost reasons. Before Qihengxing took over the project, a reagent raw material supplier provided Party A with a solution, but the product frequently generated quality complaints from clients.
(two) Qihengxing delivery results
After receiving the client's project commission, the Qihengxing R&D team re-evaluated the technical route, streamlined the R&D ideas and formulated a development plan. After rigorous demonstration and experimental optimization verification, they ultimately helped the client achieve significant improvements in technical parameters:
Based on Qihengxing's efforts in the probe design and process optimization of this test kit, as well as the stable supply of molecular diagnostic enzymes produced industrially under the ISO13485/ISO9001 quality system, the product has been stable and has been unanimously recognized by end users in the more than two years since the customer's product was launched on the market.
(three) Partial data sharing
Note: The development process and problems encountered in the SNP detection kit described in this article are universally applicable to the development of detection kits based on PCR and qPCR methods. The SNP detection kit is used as an example in this article.
5. Product List
