Viral Safety

For 28 years, Texcell provides comprehensive, standard protocols for evaluating your cell banks, raw materials and cell derivatives such as monoclonal antibodies, recombinant proteins, vaccines and gene therapy products.

To ensure the safety of your biotherapeutic product, Texcell offers a vast array of services and tests. Every study is designed in accordance with the EU or US Pharmacopoeia and EMEA or FDA guidelines. All studies are performed in accordance to GLP-guidelines, or detailed SOPs can be provided for GMP-standard assays for batch release testing.

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Our catalogue contains more than 200 technical procedures to ensure that all viral contaminants are removed from your biotherapeutic. Texcell’s teams assist you from the R&D until the marketing authorization.

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Recombinant Protein

Regarding the guidelines (ICH, FDA, EMEA) all of the following products require a particular attention:

  • Biotechnology products derives from cell lines of human and animal origin;
  • Cell lines used to produce biologicals;
  • Production and quality control of monoclonal antibodies;
  • Monoclonal antibodies for human use.

Products derived from mammalian cell lines, monoclonal antibodies and cell lines themself must be tested in order to ensure the quality and the safety of the product.

Texcell provides GLP services from the R&D until the investigational marketing authorization to assist the biotechnological and pharmaceutical companies.

Cell Therapy product

Cell therapy product involves the fact to inject living cells in a patient. International regulatory bodies mention in guidelines the different points to consider.

  • Biotechnology products derived from cell lines of human and animal origin.
  • Quality of biotechnological products: derivations and characterization of cell subtrates used for production of biotechnological / biological products
  •  Characterization of cell lines used to produce biologicals
  •  Human cell based medicinal products
  •  Virus safety evaluation of biotechnological investigational medicinal products

The cell based products are viable human cells. Those cells can be allogeneic or autologous and may be combined with non-cellular components and be genetically modified.

The risk of cell based medecinal products administration will highly depend on various parameters such as the origin of the cells, the process, the therapeutic use…

That is why, Texcell offers specific services for each studies.

Gene Therapy Product

Gene therapy involves the use of nucleic acid as a drug to treat disease. To be injected in the patient body the nucleic acid is transported by a “vector”. The origin of the “vector” could be a virus. Manufacturers must pay attention on the following points:

  • Characterisation of cell substrate used  for production of biotechnological and biological products.
  • Characterization of cell lines used to produce biologicals
  • Human somatic cell therapy
  • Replication  competent  retrovirus in retroviral vector based gene therapy products and during follow-up of patients in clinical trials using retroviral vectors
  • Equality, preclinical and clinical aspects of gene transfer medicinal products

Depending of the “vector”, Texcell will offer you a wide range of protocols to ensure the safety of your product.

Vaccines

There are many different ways to product a Vaccine. A few of the main areas of research include the following:

  • Live attenuated virus vaccines
  • Inactivated virus vaccines
  • Virion subunit vaccines
  • Live recombinant virus vaccines
  • Virus-like particles
  • DNA vaccines
  • Synthetic peptide vaccines

Regulatory guidelines give the point to consider. By knowing those guidelines, Texcell will help you to ensure the safety of your vaccines.

 Other products

Texcell also provides services for blood derivated products and medical devices.