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Biologic Therapeutics Development, Part 1: Definition and Distinct Characteristics

Camargo

Recombinant therapeutic proteins. Fusion proteins. Monoclonal antibodies (mAbs). They are often heat sensitive, membrane impermeable, subject to enzymatic degradation, and susceptible to microbial contamination (a factor which impacts manufacturing steps and quality considerations). Gene and cellular therapies.

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HPAPIs – Current Interest of the Pharmaceutical Industry

Roots Analysis

This has led to their widespread production and extensive use in the treatment of various indications including hormonal imbalances, oncological disorders and respiratory disorders. Antibody-Drug Conjugates: ADCs are monoclonal antibodies (mAbs) attached to surface antigens by chemical or a liable linker.

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PFIZER REPORTS STRONG FIRST-QUARTER 2021 RESULTS

The Pharma Data

Biosimilars, which grew 79% operationally to $530 million, primarily driven by recent oncology monoclonal antibody biosimilar launches of Ruxience (rituximab), Zirabev (bevacizumab) and Trazimera (trastuzumab) globally, as well as continued growth from Retacrit (epoetin) in the U.S.; A decision from the EC is expected in 2022.