The US FDA expects biosimilar developers to provide data from switching studies to demonstrate interchangeability with a reference biologic in draft guidance published today.
The majority of biomanufacturers use single-use systems at least in the development stage says Entegris’ Eric Isberg, but scaling-up will always be a problem.
Horizon Discovery Group has extended its CRISPR technology license to improve the performance of CHO cell lines for biomanufacturing.
Siemens and GEA have developed a continuous manufacturing platform for pharmaceuticals that integrates the former’s quality control software.
Pfizer and industry groups have criticised the US FDA over the randomness of a four-letter suffix demanded in the nonproprietary names of biological products.