The manufacturing process for biologic therapies such as monoclonal antibodies (mAbs) is relatively complex, often involving several steps for production and purification. When using mammalian production systems, such as Chinese Hamster Ovary (CHO) cells, significant effort must be made to generate, select, and characterise the production cell bank. There must also be additional effort in developing and validating the production process ensuring not only that product yield and quality fall within the target specification, but also meet the requisite biosafety levels, for example through a viral clearance validation study. Where single-use manufacturing systems are now very common in the industry, this does not obviate the need for the validation of appropriate cleaning regimens across the manufacturing process. A further major consideration includes the assessment of raw materials used within the manufacturing process, these must be of the appropriate parenteral grade and have assurance over the continuity of supply or contingency for alternate/dual supply. Overall, this development can take several months.
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