In the bioprocessing industry, in order to make full use of upstream advances in an efficient manner, it is essential that downstream processes are intensified.
This article outlines six recent regulatory changes in China intended to protect patient safety as well as reduce regulatory burdens and minimize delays.
This white paper outlines how connectivity and comprehensive automation solution can facilitate technology transfer and scaling from process development to final manufacturing scale.
Through common sense and creative thinking, the industry can discover new ways to achieve success and sustainability in the biosimilar market.
A single-step downstream process using protein A chromatography to purify a bispecific antibody (BsAb) in early screening has been successfully developed to replace an existing-three step process.
Follow the paths of two companies as they learn how a science-led, risk-based development approach yields a more successful outcome in the long run.
Organizations recognize the growing need for control of the entire cold chain as the changing global scenario requires highly efficient processes and flexibility.
Here we describe a process development methodology that enables design of either a batch or a continuous chromatography step based on the same set of experimental data.
Once deemed an “experts-only” approach to chemical synthesis, flow chemistry is a cost-efficient technique growing in popularity that can increase safety and flexibility and improve product quality.
Developed by the FDA, the Biopharmaceutics Classification System helps companies when they file for bioequivalence of dosage forms based on in vitro dissolution testing.
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