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Virology Testing Service

Virology Testing Service

Creative Biogene offers a trusted and efficient virology testing service for biotechnology products and clinic products. Our virologist team is dedicated to developing excellent virology testing services for clients. Based on the experienced staff and state-of-the-art technology, we will provide virology testing services with high quality and convincing results. Following the guideline of FDA, ICH and WHO, Creative Biogene employs multiple and validated assays for virology testing, including in vivo assay, in vitro assay, PCR-based assay and cell-based assay. Meanwhile, custom testing service is welcome.

Using cell lines for production of a biotechnology product is under the risk of viral contamination. The viral contamination could cause some clinical consequences even serious illness. Therefore, it is necessary to ensure the viral safety of products by the application of a virus testing program and assessment of virus clearance and inactivation in manufacturing process. Viral contamination of biological products may result from the original source of the cell lines or from adventitious introduction of virus during production processes. During manufacture process, adventitious viruses may unexpectedly be introduced, for example, by using contaminated reagents.

As a leader in virology testing service, Creative Biogene offers virology testing service for:

  1. Raw Materials;
  2. Unprocessed Bulk Lot;
  3. Final Products;
  4. Virus Bank Characterization;
  5. Cell Line Characterization.

Creative Biogene offers virology testing service including:

  1. Replication-Competent Retrovirus Testing Service
  2. Replication-Competent Lentivirus Testing Service
  3. Replication-Competent Adenovirus Testing Service
  4. Replication-Competent Adeno-associated Virus Testing Service
  5. Viral Testing & Clearance

Reference:
1. ICH Topic Q5A; Quality of Biotechnological Products: Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin; EMEA; 2006.

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