Recipharm Advanced Bio, a segment of CDMO Recipharm, and Infant Bacterial Therapeutics (IBT) began a process performance qualification (PPQ) for IBT’s lead product, IBP-9414. The PPQ program will take place at Recipharm’s microbial manufacturing facility in Cuxhaven, Germany.
“By combining IBT’s innovative approach with Recipharm Advanced Bio’s microbial expertise and accelerated path to manufacturing, we are ensuring PPQ and commercial readiness are delivered on a fast and reliable timeline,” said Vikas Gupta, president of Recipharm Advanced Bio.
“IBP-9414 will be the first live biotherapeutic product (LBP) globally and we now proceed to process validation for drug substance,” added Staffan Strömberg, CEO at IBT. With the possibility of Recipharm Advanced Bio being a future drug substance supplier, we are strengthening our commercial supply chain possibilities.”
According to Gupta, Recipharm Advanced Bio’s Cuxhaven site offers integrated bacterial capabilities covering the full product lifecycle, from preclinical development through commercial supply. The facility provides viral and bacterial cell bank production, development, scale-up, and production of virus-based therapies and vaccines (AAV, lentivirus, oncolytic virus), sterile fill and finish, analytical services, recombinant proteins, and monoclonal antibodies.
The company runs a network of advanced therapies medicinal product facilities and centers of excellence (Cuxhaven: viral vectors and bacteria; Oeiras, Portugal: recombinant proteins and LBPs; and Watertown, United States: nucleic acids).
