06.17.19 -- Strategies For Success With Novel Therapeutics

Bispecific antibody development presents many challenges in product expression, bispecific purification, product stability, and scale up of the manufacturing process; therefore, CMC strategies are critical for developing and marketing bispecific drugs. 

There is an increased risk of viral contamination in settings where ATMPs are prepared, making it critical to understand the contamination risks and the solutions available to control them.

As India’s biosimilar market moves toward a promising future, it is important to gain an overview of the current regulatory and clinical expectations in India for biosimilar products.

Protein Sciences learned several valuable lessons during the development and final regulatory approval of its recombinant hemagglutinin (rHA) influenza vaccine, Flublok.

A new adsorbent material using a novel proprietary structure overcomes the diffusional and flow limitations of packed bed chromatography purification systems and also aims to address the capacity issues of chromatography membranes.

An outlook on the market shows plasma fractionators will have to look to innovation and other opportunities for supply, in order to meet the needs of patients.