Newsletter | June 14, 2019

06.14.19 -- Process Development And Regulatory Guidance For Today's Biomanufacturing Challenges

 
CMC Strategies For The Development Of A Bispecific Antibody Platform For Cancer Immunotherapy
 

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. 

Development Pathways For ATMPs: Virus Safety Challenges And Regulatory Perspective
 

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.

The Current Landscape For Developing Biosimilars In India
 

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.

Benefits And Challenges Of Driving Modernization In Vaccine Development
 

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

Addressing New Chromatography Challenges With Fiber Adsorbents
 

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.

A Plasma Problem: Dwindling Supply In The Face Of A Growing Demand
 

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.