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Breaking News on Biopharmaceutical Development & Manufacturing

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Biosimilar interchangeability

FDA calls for switching studies in draft interchangeability guidelines

The US FDA expects biosimilar developers to provide data from switching studies to demonstrate interchangeability with a reference biologic in draft guidance published today.

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Single-use bioreactors: 2,000L a ceiling, says new BPSA board member

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 to use CRISPR tech to enhance CHO cell lines for biomanufacturing

Horizon Discovery Group has extended its CRISPR technology license to improve the performance of CHO cell lines for biomanufacturing.

GEA and Siemens team on continuous processing tech

Siemens and GEA have developed a continuous manufacturing platform for pharmaceuticals that integrates the former’s quality control software.

US FDA sticks with four-letter random suffix for biosimilar names

‘Meaningless suffixes’ slammed by industry in FDA naming guidance

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.

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