PROCESS DEVELOPMENT AND CONTROL IN ANTIBODY MANUFACTURING: FROM CELL LINE ENGINEERING TO FINAL PRODUCT QUALITY

Аннотация

The continuous expansion of antibody-based therapeutics has fundamentally
reshaped the landscape of modern biopharmaceutical manufacturing. Monoclonal
antibodies (mAbs) now constitute the dominant class of biologic medicines due to
their high specificity, predictable pharmacological behavior, and proven clinical
efficacy across a wide range of therapeutic areas, including oncology, autoimmune
diseases, and infectious disorders. This rapid growth has placed significant
pressure on manufacturers to develop production platforms that are not only
efficient and scalable but also capable of delivering consistently high-quality
products.