For more than 25 years, Texcell has been providing comprehensive, standard protocols for evaluating your cell banks, raw materials and cell derivatives such as monoclonal antibodies, recombinant proteins, vaccines and gene therapy products.
Each study plan is drawn up in accordance with the EU or US Pharmacopoeia and EMEA or FDA guidelines. To verify assay accuracy and reproducibility during development, each test has followed a specific development process (set out in a validation file). Each study plan is designed to GLP standards, and if you request GMP-standard assays for batch release testing, we will provide you with SOP dedicated to suit your needs.
To guarantee the biosafety of your product, this section provides you with an exhaustive list of the study plans we offer. All of our study plans and assays are able to be customized to suit a clients request.
Moreover, at the end of the section, you will find several case studies with specific testing strategies, depending on the cell line used.
If you need to evaluate the biosafety of recombinant proteins, monoclonal antibodies, gene therapy vectors or cell lines, do not hesitate to contact us!