With the continued development and clinical availability of advanced therapeutic medicinal products (ATMPs), clinical and commercial manufacturers have had to adapt to both the greater complexity associated with production; as well as the implications of biocontainment associated with these therapies.
To an extent, the industry has already faced and overcome the challenge of dealing with biocontainment during the production of treatments now considered classical biological therapies. For example, the production of monoclonal antibodies (mAbs) require the use of genetically modified producer cells, such as Chinese Hamster Ovary (CHO) cells, which are typically classified as biosafety level 2 (BSL-2) by developers and so must have the appropriate biocontainment protocols and procedures in place to allow manufacturing to proceed. Fortunately, attaining BSL-2 containment can be relatively straight forward when using contained systems such as bioreactors.
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