In-vitro Diagnostic (IVD) Platform Development and Process Optimization Services
Time：2023-12-14 Hits：207
Seebio Biotech (Shanghai) Co., Ltd. is a national high-tech enterprise and a national “little giant” in the field of biological reagents, specializing in R&D, production, and services. Established in 2003, the company has been dedicated to raw material research and development, adhering to independent innovation, and has continuously supplied raw materials for research and production reagents to diagnostic reagent, vaccine, antibody protein drug manufacturers, CROs, CDMOs, research institutions, etc. Seebio focuses on IVD biochemical diagnosis, immunodiagnosis, molecular diagnosis, blood diagnosis, microbial diagnosis, POCT, and biopharmaceuticals. Over 1,000 IVD R&D and production companies nationwide have recognized Seebio Biotech as their comprehensive raw material reagent supplier, OEM, and custom production partner.
With 20 years of cooperation, customers trust Seebio Biotech's product quality, compliance, and reliability. In addition to ensuring the supply of reagent raw materials, Seebio strives to provide more comprehensive technical services for IVD R&D and production enterprises: Seebio Biotech has launched multi-method reagent development services such as chemiluminescence, immunochromatography, immunoturbidimetry, and ELISA, covering everything from monoclonal antibody production to the entire process from discovery, pair screening, protein labeling, platform verification, process optimization to large-scale production.
Why choose Seebio for IVD technology R&D cooperation?
Seebio has various technical expertise, comprehensive and high-quality reagent raw material control capabilities, and a comprehensive IVD detection platform (including colloidal gold chromatography, immunofluorescence chromatography, time-resolved immunofluorescence, immunoturbidimetry, and latex-enhanced immunofluorescence). Seebio provides professional reagent raw material screening, application performance verification, reagent performance optimization, and OEM services.
It offers large-volume liquid preparation and filling, freeze-drying; recombinant protein prokaryotic expression services; mono/polyclonal antibody customization services; affinity determination services; protein biomarker assay development; antibody development, production, and verification; IVD paired raw material design, screening, and development.
Our advantages:
Seebio is committed to providing high-quality products and excellent services.
Strong team: Composed of experts engaged in the development and production of chemiluminescence/immunochromatography products from well-known domestic IVD reagent manufacturers.
Core advantages: mature antigen-antibody labeling coupling process, mature luminescence/immune detection system and optimization process, and complete R&D and production optimization process.
Strict quality control: Quality control is carried out in strict accordance with GMP and ISO13485 quality management system requirements.
Service Area
-Raw material screening
-Optimization of raw material labeling process system (horseradish peroxidase, alkaline phosphatase, acridinium ester, colloidal gold, fluorescent microspheres, quantum dots, magnetic particles, etc.）
-IVD paired antigen and antibody screening
-Production process optimization
-Production platform guidance and personnel training
-Large packaging production
-New product customization development
Specific service content and cycle:
|
Serial number
|
Service items
|
Content
|
Customers need to provide
|
Cycle
|
|
1
|
Protein (antibody) labeling
|
Alkaline phosphatase (ALP) labeled antibodies
|
Corresponding protein raw materials and markers, or just provide protein raw materials or specified items
|
3-4 Days
|
|
2
|
Horseradish peroxidase (HRP) labeled antibodies
|
3-4 Days
|
||
|
3
|
Acridinium ester (AE) labeled antibodies
|
2-3 Days
|
||
|
4
|
TMB/OPD substrate system
|
2-3 Days
|
||
|
5
|
APS-5 Substrate System
|
5-10 Days
|
||
|
6
|
CDP-star substrate system
|
5-10 Days
|
||
|
7
|
Biotin-labeled antibodies
|
2-3 Days
|
||
|
8
|
Magnetic beads coated antibodies
|
2-3 Days
|
||
|
9
|
Fluorescent microsphere-labeled antibodies
|
2-3 Days
|
||
|
10
|
Colloidal gold labeled antibodies
|
2-3 Days
|
||
|
11
|
Screening and evaluation of IVD paired raw materials
|
Antibody/antigen pairing and antigen screening verification based on colloidal gold, fluorescence immunochromatography and magnetic particle chemiluminescence (AE system)
|
|
15-20days (excluding the time of clinical sample collection）
|
|
12
|
IVD kit OEM development (completed preliminary research and development）
|
Based on ELISA, immunoturbidimetry, colloidal gold, fluorescence immunochromatography and chemiluminescence (AE system, etc.）
|
3-6months
|
Recommended services:
-Antigen analysis and design
-Recombinant antigen expression
-Mono/polyclonal antibody customization
-Antibody pairing screening
-Colloidal gold labeling and test strip development
-ELISA kit development services
Seebio Biotech will continue to optimize its products and technical services, and its business covers the pre-development of IVD raw materials, immune antibody development, in vitro diagnostic-related tool enzymes, immune antibodies, antigens, scientific research chemical raw materials, and chemical reagents, and other related technical services. For more product details, please contact us at service@seebio.cn or call +86 21 58183719 or WeChat: +86 158 0195 7578.