Biopharmaceutical manufacturing has undergone multiple waves of transformation.
Single-use technologies have brought flexibility, process intensification has improved productivity and digital systems have increased visibility into operations and product quality.
Together, these advances have helped the industry to manufacture increasingly complex biologic medicines with greater speed and consistency.
Beate Mueller-Tiemann, Chief Technology Officer at Cytiva, reports.
A new challenge is emerging
The next generation of therapies is becoming more diverse, more complex and, often, more difficult to develop, transfer and manufacture at scale.
Bispecific antibodies, antibody-drug conjugates, cell and gene therapies, viral vectors, RNA-based medicines and other emerging modalities place very different demands on process development and manufacturing.
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