Is there an accidental viral contamination of my product?
Since 1987, Texcell is a trusted partner to evaluate biological products, cell banks, raw materials and cell derivatives such as monoclonal antibodies, recombinant proteins, vaccines and gene therapy products.
Texcell offers a wide range of PCR reactions for the detection of viral nucleic sequences. A PCR cannot tells if there is an infectious, potentially harmful, viral particle. This is why Texcell has developed delicate, sensitive, cellular methods to assess the presence of known or unknown infectious virus.
Texcell meets worldwide regulatory requirements, FDA, EMA, WHO, PMDA
Texcell has a long experience testing the most diverse products, from the conventional Mab and cell lines to the most unusual natural products. Some products can be difficult to assess on living cells, because of the toxicity or other inhibitory effects. Texcell’s scientists have developed over time many methods to circumvent these problems and test your products with the most sensitivity.
At the forefront of biomedical research, biological medical products, also called biopharmaceuticals, ATMP or simply biologics, are considered as game changer drugs for many pathologies.
Based on recombinant DNA techniques and produced by biotechnology methods, biologics production process must be thoroughly tested.
Texcell offers a broad range of technical procedures to ensure the biosafety of your biotherapeutic products, from recombinant proteins, MAb to cell and gene therapy.
Cell therapy is an emerging therapy field in which cellular material is injected to a patient.
Therefore, the production process must meet regulatory requirements for safety, purity and effectiveness.
Using in vitro and in vivo assays, Texcell offers you to characterize your product for safety, sterility, purity, identity, and potency (biological activity) before administration to the patient.
As says the European Society of Gene and Cell Therapy: “Gene therapy is the use of genetic material to treat genetic diseases. This may involve adding a wild type copy of the gene (gene addition) or altering a gene with mutation to the wild type gene (gene editing). To get the gene into the genome inside the cells, modified viruses or other vectors are used.
Some developments that have been crucial for gene and cell therapies are gene editing, induced pluripotent (iPS) cells and safer viral vectors for gene delivery.”
Texcell offers a large panel of tests and methods to ensure the safety of gene therapy products.
Viral vaccines can be developed by classical techniques with attenuated infectious agents or by genetic engineering to produce proteins from a pathogen. As for any bioproduction of therapeutic component, thorough testing of the production process and the products are required.
Texcell has a large collection of tests and testing methods to satisfy most of manufacturers’s needs using biological materials.
- Sterility, Mycoplasma, Prions testings
- Virus in vitro and in vivo testings
- Porcine and Bovine contaminants (testing according to 9CFR §113, media supplements…)
- Retrovirus testings
- PCR and Q-PCR assays
Each manufacturing process is unique and Texcell designs and executes each assay on a case-by-case basis.
Texcell offers cGMP testing to provide you a certificate of analysis of your raw materials and cell derivatives, including monoclonal antibodies, recombinant proteins, vaccines, and cell and gene therapy products.
Depending on your cell derived-products and raw materials, Texcell offers tests for adventitious viruses using in vitro assays.
Texcell has developed an extensive array of technical documents validating the usage of various cell lines coupled with qPCR to detect viruses from different origins including human, simian, rodent, equine and insect.
For CHO produced MAb, Texcell deploys a dedicated strategy to release your batches, combining in-vitro assays, TEM and MVM testings.
Texcell offers a vast array of services and bioassays, by PCR and on sensible living cells. 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 or GMP-guidelines.
Do not hesitate to entrust us with your biotech products for viral safety testing including batch release testing to qualify the biosafety of your bioproducts.
Texcell innovates and is agile and equipped to respond to new contaminations
Against SARS-COV-2 / Covid19 and soon Monkey Pox virus, Texcell offers a broad range of biosafety testing. Check out Texcell’s offer. Our bioassays can be customized to meet your needs.