In this Issue:
As new drug formats such as cell & gene therapies, bispecific antibodies, or even conjugates are filling clincical pipelines, new and cost-effective processes are needed to make them a business case. Contract manufacturers that have all the capacities in-house to develop a biologic/advanced therapy GMP compliantly from preclinical stage to the filled & finished product have good chances in the emerging new markets. As yields have been reported up to 16g/l for bispecific antibodies, formulation technologies that inhibit protein aggregation are crucial to assure drug safety and efficacy as well as DSP equipment to manage to USP yield.
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