Operation, Qualification and Documentation of Tangential Flow Filtration System to produce Drug Substance of Vaccines in Good Manufacturing Practices Facility

Abstract

Vaccines against infectious diseases including emerging etiological agent are being produced through various major steps in Good Manufacturing Practices approved world class facilities with the core divisions of Upstream & Downstream processes followed by quality attribute testings as per approved license from the regulatory authorities. The current review article will afford the reviewer to get hold of awareness on the operation and qualification of downstream equipment's especially Tangential Flow Filtration system and its validation as a purification tool for the manufacturing of Drug substance in vaccines against various pathological agents. The Scope of current article nourish and educate the industrial scientific personnel’s and entrepreneur, who are working in biopharmaceutical industries like vaccines and Bio-therapeutics to acquire the scientific knowledge for operation, optimization, qualification and documentation of tangential flow filtration system to produce drug substance of vaccines in GMP facility. Even though the article summarizes and offers the methodological approach for the selection of TFF system as a purification tool for downstream process, The authors opinionated that the thorough familiarity given in this article regarding the pre-process concepts which starts from the industrial equipment selection & purchase procedure of the system and its operation, dual side qualification, validation, optimization of process variables with experimental execution for the successful production of vaccine drug substance would be definitely be unique and worthy. After review of this article, one can gain the complete comprehensive knowledge and assurance about the Selection, Purchase, Qualifications, Validation and Process utilization and Optimization of process variables with sustaining consistent quality of the product as output with benefit of expertise.