lVD reagent and kit contract manufacturing service
Background
As veterans in the field of diagnostic enzymes, we deeply understand that selecting high-quality raw materials and maintaining stable production processes are key elements in the successful development of in vitro diagnostic (IVD) kits. Based on this, we offer comprehensive, one-stop custom development and manufacturing services (CDMO) for IVD reagents and kits, helping you transform cutting-edge diagnostic ideas into market-leading products with stable performance, compliance, and scalable production capabilities.Our CDMO services encompass a complete value chain from R&D to mass production. These services encompass meticulous raw material selection, in-depth product research and development, rigorous stability studies and testing, and flexible capacity expansion and commercial production (including customized finished and semi-finished products), seamlessly transitioning products from concept to market.
Leveraging our extensive CDMO experience, Creative Enzymes Diagnostic has successfully established numerous technology application platforms for clinical diagnostics across a wide range of diseases. These platforms, with their exceptional performance and stability, have earned the trust and widespread adoption of numerous clients, setting a benchmark in the in vitro diagnostics field. If you're seeking a professional in vitro diagnostics outsourcing partner to strengthen your product portfolio, we offer a comprehensive one-stop service system to precisely meet your individual needs and work together to create a new future for diagnostics.
Figure 1. lVD R&D service direction (Creative Enzymes)
Services We Provid
Through our diverse and proprietary IVD testing technology platform system, covering ALP chemiluminescence, AE chemiluminescence, time-resolved immunofluorescence, colloidal gold, latex turbidimetry, flow cytometry, and ELISA, Creative Enzymes Diagnostic provides contract manufacturing services covering the entire life cycle of IVD products:
| Service Categories | Specific Services |
|---|---|
| Co-development and Process Transfer | Perform process validation and optimization based on the client's prototype formulation or technical data |
| Provide process transfer and productivity improvement services for the client's existing products | |
| Customized Formulation and Manufacturing | Liquid Reagents: Various buffers, substrates, detection antibodies, enzyme conjugates, etc |
| Lyophilized Powder Reagents: Provide stable lyophilized powder reagents suitable for point-of-care (POCT) products | |
| Pre-aliquoted microplates: ELISA or chemiluminescent plates coated with capture antibodies | |
| Full kit assembly: We provide complete kit assembly and packaging services, including calibrators, quality controls, and reaction solutions | |
| Manufacturing Platform | Immunoassay Platform: Production of reagents such as ELISA, chemiluminescence, fluorescence immunoassay, and colloidal gold chromatography |
| Molecular Diagnostic Platform: Production of PCR-related reagents (qPCR/dPCR), nucleic acid extraction reagents, and reverse transcription reagents | |
| Biochemical Testing Platform: Production of various biochemical testing reagents | |
| Quality Control and Stability Studies | Provide comprehensive product performance testing |
| Comprehensive quality control platform: enzyme activity analysis; protein concentration determination; purity analysis (SDS-PAGE, HPLC); functionality testing; sterility and endotoxin testing; batch-to-batch consistency evaluation | |
| Assist clients with accelerated and real-time stability studies, providing data support for product expiration date determination. | |
| Packaging and Labeling | Provide professional internal and external product packaging and labeling services tailored to client brand and regulatory requirements |
Figure 2. General Service process (Creative Enzymes)
Why choose us for your Ab initio modeling?
- Potential for customized formula development and optimization: Nearly 60% of our R&D staff, including nearly 90% with doctoral degrees, possess excellent development capabilities.
- "Enzyme-reagent" collaborative optimization achieves breakthrough performance: We provide more than just "production," but "optimization." We can co-design your test kit from the very upstream enzyme molecule level.
- Strict quality control and registration support: We implement three-level quality control from raw materials, intermediates, to finished products to ensure data authenticity, integrity, and traceability.
- Professional production covering mainstream technology platforms: Our production lines and experience cover most mainstream diagnostic technology platforms.
- Flexible cooperation model: matching the different stages of customer products.
Case Study
- After the target diagnostic enzyme is customized for small-scale production, quality control was performed by SDS-PAGE (A), WB (B), and HPLC (C&D), and endotoxin content is tested (E&F) to ensure that the small-scale sample meets customer needs.
Figure 3. Diagnostic enzyme products QC example (Creative Enzymes)
Contact our business development team today to discuss your specific project needs! Let us leverage our expertise in enzyme technology and reliable manufacturing capabilities to ensure the success of your IVD product.
