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    The various GMP (good manufacturing practice) guidelines and international ISO standards regarding GMP cleanrooms are complex and often seem contradictory in their guidance, leading to confusion and, at times, misinterpretation. In the case of routine environmental controls, there is little prescriptive guidance and it is up to the cleanroom owner to devise an appropriate control plan. In the generally prescriptive GMP industry, this lack of direct instructions leaves users perplexed.
    Reducing costs while developing efficient bioprocesses as fast as possible is a rigorous task. Intensive screenings, including a vast number of different experiments regarding strains, media composition and process conditions, have to be conducted in order to create high yields and product titers.