EMA approves Biocon Biologics’ new mAbs facility in India
Renews GMP certifications for India and Malaysia sites
Renews GMP certifications for India and Malaysia sites
This approval reflects Biocon Biologics' compliance with the highest international regulatory standards
The inspection report contains no 'critical' observations and only one of the deficiencies is categorized as 'major' which is being addressed expeditiously in consultation with the regulatory agency
The multi-partner team will integrate new technologies across the entire mAb production workflow, from cell line development to purification
The antibody was designed and developed at Abzena’s Cambridge, UK,
This collaboration aims to combine Molcure’s cutting-edge AI technology with Boehringer Ingelheim’s extensive expertise in drug discovery
Data highlight ambition to transform prevention and treatment for serious bacterial infections and develop novel preventative strategies for respiratory viral infections
The new site will increase Syngene's total single-use bioreactor capacity to 50,000L
Overall investment in the US facility is estimated around US$50 million
The transaction is expected to result in approximately $175 million to support further development of IMG-007
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