南宫NG28

Our service

Centre Testing International Co., Ltd. (CTI) is the pioneer and leader in the TIC Industry which provides one-stop solutions on testing, inspection, certification, calibration, audit, training & technical services.

 
By Industry

Our service capabilties cover the upstream and downstream of the supply chain including textile and apparel,toys,electronic appliances,medical health,food...andother industries.
Specialty

Comprehensively guarantee quality and safety, promote compliance and innovation, demonstrate brand competitiveness, and achieve higher quality, healthier, safer, and greener sustainable development.
AUTHORITY & TRUST
QUALITY & VALUE
Biosafety Testing

Biological products are a type of products used for prevention, treatment and diagnosis, such as antibody drugs, vaccines, gene and cell therapy drugs, etc., prepared from biological materials such as microorganisms, cells, tissues, and body fluids. Due to their different production methods from chemical drugs, biological products need to undergo strict biosafety testing at all stages, including raw materials, virus banks, cell banks, harvested fluids, and stock fluids. CTI Pharma and Medical Services· provides you with a variety of exogenous contamination factor inspections at all stages of biological product production.

Biosafety Testing

Virus testing

Virus contamination inspection of biological products can be divided into extensive screening for unknown viruses and inspection for specific viruses. CTI will conduct internal and external virus contamination inspections based on customer needs in accordance with the relevant standards of the International Council for Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Q5A, the General Chapter for Virus Safety Control of Biological Products of the Chinese Pharmacopoeia (ChP), the United States Pharmacopoeia (USP), and the European Pharmacopoeia (EP). Our testing items include:

  • Virus titer determination
  • Exogenous virus screening based on in vitro cell culture
  • Specific virus inspection based on nucleic acid amplification technology (NAT)

Mycoplasma Testing

Mycoplasma is a common contaminating bacterium in cell culture, which is very easy to spread on a large scale. It not only affects cell metabolism, resulting in a decrease in the yield and quality of the final product, but is also related to many human diseases. Regulatory authorities in various countries have stipulated that mycoplasma contamination detection should be carried out in the production process of biological products. CTI provides three mycoplasma detection strategies based on the pharmacopoeia method (ChP3301, EP 2.6.7, USP 63): culture method, indicator cell culture method (DNA staining method), and nucleic acid amplification method (NAT).

Service process

 

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