- Recipharm Advanced Bio and Infant Bacterial Therapeutics have begun Process Performance Qualification for IBP-9414 at the CDMO’s Cuxhaven site.
- IBP-9414 holds Breakthrough Therapy and Rare Paediatric Disease designations and targets mortality and gastrointestinal injury in premature infants.
Recipharm Advanced Bio and Infant Bacterial Therapeutics AB (IBT) have initiated Process Performance Qualification for IBT’s lead product, IBP-9414. The programme will take place at Recipharm’s microbial manufacturing facility in Cuxhaven, Germany, and marks a key milestone on the pathway to regulatory approval.
IBP-9414 is designed to address mortality and gastrointestinal injury in premature infants. The therapy holds Breakthrough Therapy designation for gastro-intestinal mortality and Rare Paediatric Disease designations. PPQ represents the next step towards commercial readiness for the product.
Recipharm Advanced Bio, a segment of Recipharm and a Contract Development and Manufacturing Organisation, will support the process validation activities for the drug substance.
“Partnering with Infant Bacterial Therapeutics on this breakthrough therapy underscores our shared commitment to addressing critical unmet needs in vulnerable patient populations.”
Vikas Gupta, president of Recipharm Advanced Bio
IBT stated that IBP-9414 will be the first Live Biotherapeutic Product globally. The company has selected Recipharm Advanced Bio for drug substance process validation and highlighted the potential for the CDMO to serve as a future supplier within its commercial supply chain.
Recipharm Advanced Bio provides development and manufacturing services for modalities including live-microbial biopharmaceutical products, viral vectors, and nucleic acid-based technologies. The Cuxhaven site operates under Vibalogic GmbH, with regulatory documentation listed under that entity.
