Production of a clinical batch of a therapeutic antibody

A client has obtained the authorization for the employment of an antibody in phase I clinical trials and has approached us requestion the generation Master and Working Cell Banks and the production and release of a clinical batch of a few grams of purified antibody. The hybridoma, which was previously adapted to grow in serum free medium (SFM) in areta's R&D division was then expanded and fully characterized cell banks were generated in our GMP facility. Based on the productivity determined after the adaptation to SFM, the hybridoma was grown using disposable bioreactors and the bulk harvest was concentrated and purified on Protein A chromatography followed by polishing steps as established in the Drug Master File. The antibody was subjected to nanofiltration and filled in the final vials. After passing the extensive QC analysis as established in the Quality Agreement, the clinical batch was released. The batch was also subjected to a stability study at different temperatures and time points according to a protocol established with the client.

Isolation and expansion of mesenchymal stem cells from a tissue

A client who had previously requested the establishment of a defined protocol for the isolation and expansion of mesenchymal stem cells starting from a donor tissue in our R&D laboratories, further inquired us for the validation of the same process and production of batches of mesenchymal cells for a clinical trial.

The process that was previously developed using GMP-grade media was validated in our GMP facility in order to assess the reproducibility and robustness of the procedure to avoid changes in cell phenotype and karyotype and ensure a sterile product without traces of manufacturing materials. The shipment from the facility to the hospital was validated and a qualified courier was identified to guarantee the correct temperature during the transport of highly perishable material such as living cells.

Production of a plasmid DNA vaccine

areta was contacted for the production of a plasmid DNA for use in clinical trials of DNA vaccination in the field of oncology. We optimized a process for the production of plasmid DNA in GMP conditions and described it in the Drug Master File. We supported the client in the preparation of the required regulatory documentation to obtain the approval for the clinical trial from the authorities. The production is performed using disposable bioreactors for the growth of E. Coli, an innovative approach that allows us to address the manufacturing of patient-specific drugs very easily and with reduced risks and costs. The DNA was extracted and purified from the bacterial cells and subjected to exhaustive QC tests to verify its compliance for the use in humans.