Open AccessBest practices for successful implementation of single‐use technology and qualification
Author(s) -
Hess Philipp N.,
Dudziak Gregor
Publication year - 2014
Publication title -
engineering in life sciences
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.547
H-Index - 57
eISSN - 1618-2863
pISSN - 1618-0240
DOI - 10.1002/elsc.201300094
Subject(s) - biomanufacturing , bioprocess , manufacturing engineering , product (mathematics) , factory (object oriented programming) , engineering , computer science , risk analysis (engineering) , operations management , systems engineering , business , microbiology and biotechnology , geometry , mathematics , chemical engineering , biology , programming language
Single‐use bioprocessing facilities are providing flexible capacity for clinical trials and low‐ to mid‐volume market supply. However, while this production technology reduces manufacturing cost, quantum jumps in healthcare cost efficiency can be expected from new product technology. In the future, new product technology such as virus‐based systems will need smaller bioprocessing capacities which may be provided by single‐use facilities. The single‐use biomanufacturing facility at R entschler B iotechnologie received the 2012 F acility of the Y ear A ward in the category E quipment I nnovation. The award recognizes the project for its flexible, multiproduct manufacturing facility designed to minimize manufacturing costs and product cycle times. This clinical manufacturing facility proves concepts that pave the way toward the factory of the future for commercial biologics manufacturing. From that and more recent projects, we derived the best practices when implementing such a facility during all project phases (when assessing its feasibility, designing, constructing, qualifying, starting up, and operating it). Challenges, potential solutions, and future single‐use bioprocessing facility design objectives are discussed.