This downstream and manufacturing focused issue features articles on change notification processes for single-use systems; the growth of biosimilars; a QbD implementation in analytical development case study; an examination of using an M-pleat pattern in filtration systems; and an update on viral safety from Editorial Advisory Board member, Hazel Aranha.
Biosimilars: Tackling the Technical and Regulatory Challenges
Biosimilar products have come about as a way to make biopharmaceuticals that are otherwise too costly available to a broader market. Like generic small-molecule drugs, they build on the success of licensed products. And although regulatory pathways allow biosimilar developers to bypass certain expensive testing, they are not generic drugs. Technical challenges remain a part of their development. This Featured Report contains an overview of those challenges and articles that dive into technologies that can help, regulatory hurdles that remain, and a look at the countries that are leading the way globally.
The US Food and Drug Administration has stated its appreciation of continuous bioprocessing (CBP), and some studies have shown that it can save manufacturers time and money. However, the bioprocessing industry is still reluctant to implement continuous bioprocessing right away. It will be interesting to see which companies will be among the first-movers to harness the competitive benefits. Although few biologics today are made using CBP-enabled equipment (e.g., advanced bioreactors), the industry is changing. For biologics already in production, it…