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The patents for a number of parental biologic formulations are destined to expire in the United States between 2016 and 2027. This provides development opportunities for many companies, but also provides significant challenges. This paper discusses important development considerations of a lyophilized biosimilar as well as providing an example/case study with outcome/results.
Antibody Drug Conjugates (ADCs) are complex molecules consisting of a monoclonal antibody (mAb), linker, and cytotoxic drug. Formulation development must focus on maintaining the stability and potency of the mAb, while maintaining the integrity of the linker. This case study describes product development for phase 1 clinical manufacturing of an ADC. The goal of the study was to develop a solution formulation with an option of developing a lyophilized formulation if early stability studies indicated it was needed.
This case study provides an in-depth look at Baxter BioPharma Solutions’ latest expansion at their Halle, Germany cytotoxic facility, offering insight on:
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