CACLP 2022 Review ▏Realbio Group

Published Time:

2022-10-31

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Abstract

CACLP 2022 Review ▏Realbio Group

Realbio Group, a core raw material supplier for IVD, showcased its new products at the 19th China International Exhibition on Inspection Medicine and Transfusion Instruments and Reagents (CACLP) and the 2nd China International IVD Upstream Raw Material Manufacturing and Circulation Supply Chain Expo (CISCE), including a biological special product import and export R&D transformation platform, a complete solution for bovine serum and bovine serum albumin (BSA) specifically for in-vitro diagnostics, and customized animal immunization programs. The exhibits attracted many visitors and media attention, fully demonstrating Realbio Group's independent innovation and technological strength. 

 


 


Highlight 1 ▏Biological Special Product Import and Export R&D Transformation Platform 
 


Biobank Services 
Realbio International Biological Raw Material R&D Transformation Center has established a biobank with 3 million samples, including a 500,000-sample European biobank in cooperation with Biomex and a domestically built biobank. It meets the clinical sample needs for downstream verification of in-vitro diagnostic reagent product R&D. A Class 2+ biosafety laboratory is also available, equipped with mainstream instruments and facilities to control biosafety risks and shorten the R&D cycle, helping companies solve pain points in the R&D process. 
R&D Laboratory Services 
Within the transformation center, 100-200 square meters of dedicated space is provided. Laboratory design is completed jointly by the client and Realbio, strictly following the design and decoration to better meet the client's personalized needs. Clients can enjoy convenient access to special import and export policies, overall biosafety management, and special bonded zone tax benefits. 
R&D Transformation and Operation Services 
(1) Bonded Zone Services: Comprehensive bonded warehousing and temporary storage services are provided in the bonded zone, acting as an overseas forward warehouse for Asian businesses to improve the overseas supply chain. 
(2) Customs Clearance Services—Two Import and Export Customs Clearance Models: 
Import from abroad to China: Single entry, multiple withdrawals 
Export from China to abroad: Single entry into warehouse, multiple exports 
(3) Services include removal inspection, centralized disinfection of goods, nucleic acid testing, and agency services for dangerous goods identification reports. 
(4) Convenient policies for the import and export of special goods: 
Metrological Traceability Services 
Available products: International inter-laboratory quality assessment materials, international standards, international reference materials, and national standard substances. 
Available brands: NIBSC, RfB/IFCC-RELA, CAP, RCPA, CDC, UK NEQAS, National Institute of Metrology of China, etc.


Highlight 2 ▏Complete Solution for In-Vitro Diagnostic Bovine Serum & Bovine Serum Albumin (BSA)

Bovine Serum for In-Vitro Diagnostics 
Specifically for IVD R&D and production, interfering components are removed, with ultra-low hemoglobin and no batch-to-batch variation. 
Full process quality control from breeding to processing, stable process 
Bovine Serum Albumin (BSA) 
Realbio bovine serum albumin (BSA) is sourced from self-raised donor cattle, with stable blood sources. It utilizes StarBio purification technology, with full process quality control, low batch-to-batch variation, and stable supply.


Highlight 3 ▏Customized Animal Immunization Programs 
 


Program 1: The client provides the antigen and immunization method, and Realbio performs the immunization according to the client's program and provides the corresponding serum. 
Program 2: The client provides the antigen, and immunization is performed according to Realbio's immunization program, and serum is provided. 
Program 3: The client provides the antigen, and Realbio uses its own immunization program and automated blood collection method, with defatting and defibrillation processing (significantly reducing costs). 
Program 4: Fully outsourced production, where Realbio provides the antigen, immunization program, and blood collection method.

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On April 9, Realbio Group and the Shenzhen CDC officially signed a strategic cooperation agreement in Shenzhen. The two parties will engage in in-depth collaboration on the construction of a clinical translation evaluation system for in-vitro diagnostics (IVD), with the aim of bridging the "last mile" from the laboratory to clinical application, enhancing the industry's regulatory market access capabilities, and contributing to the development of a public service platform for the diagnostics field in the Greater Bay Area.

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