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Cellectis to build CAR-T manufacturing sites in US and Europe

In a step towards the commercialisation of its ‘off-the-shelf’ CAR-T therapies, Cellectis begins construction of a facility in France and enters lease agreement for US facility.

First oncology mAb biosimilar from Pfizer approved by FDA

US FDA approves Pfizer’s Trazimera, a biosimilar to Roche’s blockbuster product, Herceptin, for the treatment of HER2 positive breast cancer.

‘Can you manufacture consistently?’ The big question in regenerative medicine

Regenerative medicine raised $13.3bn in funds during 2018 but investors question whether treatments can be manufactured consistently, according to AMR annual report.

Biocon receives Form 483 due to risk of contamination

The US FDA issues Biocon a Form 483 with two observations, including failure to establish proper aseptic practices and lack of follow-up on data discrepancies.

GE and Amgen seek out raw material variability through data exchange

GE Healthcare partners for digital data exchange collaboration program with Amgen to advance understanding of biomanufacturing process on raw material variability.