Viral Safety
Viral Safety is a key testing service that provides assurance in your bioprocessing or manufacturing does not contain or introduce adventitious agents.
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.
“Is there an accidental viral contamination of my product?”
Texcell offers a wide range of PCR reactions for the detection of viral nucleic sequences. A PCR cannot tell 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
Methods
Texcell offers viral safety 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 viral safety of biosafety testing. Check out Texcell’s offer. Our bioassays can be customized to meet your needs.
Products
Texcell is an experienced viral safety testing vendor with a diverse product, from the conventional Mab (monoclonal antibody) 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.
Recombinant Proteins or Monoclonal Antibodies (mAbs)
At the forefront of biomedical research, biological medical products, also called biopharmaceuticals, “Advanced Therapy Medicinal Products” 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, to cell and gene therapy
Cell 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.
Gene Therapy
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
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.
Human or Animal origin Products
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
Batch Release
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.