Current Edition

New Manufacturing Technology Platforms for Biosimilars

Innovation in process and bioreactor technology, a better understanding of cell lines, advances in analytical methods and equipment, continuous processing, and single-use technologies, have accelerated, de-risked and lowered the cost for biosimilar development. Regulators are similarly clearing the path for biosimilar developers to enter the market. Biosimilar developers and CDMOs operating in the space that have invested in the appropriate technologies and have the expertise in handling other biologics have an immediate, inherent advantage over reference molecule owners. Gerrit Hagens at BioXpress Therapeutics and Simon Keen at Abzena’s Scientific Leadership Group, explain that, as more biosimilar products clear the final commercial hurdle, it becomes vital that manufacturers maintain focus on quickly and efficiently moving through development and stripping costs from their processes wherever possible.