Recipharm partners with Infant Bacterial Therapeutics on drugs for premature infants
Recipharm Advanced Bio, part of global contract development and manufacturing organization Recipharm, and pharma company Infant Bacterial Therapeutics AB (IBT) announced the initiation of Process Performance Qualification (PPQ) for IBT’s lead product, IBP-9414, which targets mortality and gastrointestinal injury in premature infants.
The PPQ program will be conducted at Recipharm’s microbial manufacturing facility in Cuxhaven, Germany, which offers integrated bacterial capabilities covering the full product lifecycle from pre-clinical development through commercial supply, according to Recipharm.
The Cuxhaven site provides comprehensive support including viral and bacterial cell bank production, development, scale-up, as well as production of virus-based therapies and vaccines (AAV, lentivirus, oncolytic virus), sterile fill-finish, analytical services, recombinant proteins, and monoclonal antibodies.
“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, said in a statement. “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, bringing this lifesaving treatment for premature infants fast to market.”
In October, Recipharm announced that its Cuxhaven facility has been designated as the company’s Center of Excellence for Analytical Services tailored to advanced modalities. With more than 15 years of experience in analytical method development and qualification, Cuxhaven’s team specializes in both compendial and non-standard assays, including microbiological and viral assay validation, nucleic acid quantification, and advanced molecular techniques such as ddPCR, qPCR, and Western blot.
According to Recipharm, these capabilities make the site a key asset for biologics and advanced therapy medicinal products (ATMPs).
The facility in Cuxhaven provides support in 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 (mAbs).
"IBP-9414 will be the first LBP (Live Biotherapeutic Product) globally, and after careful consideration, we now proceed to Process validation for Drug substance with Recipharm Advanced Bio in Cuxhaven,” says 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. We feel that we are in good hands for this work, given Recipharm Advanced Bio's deep expertise and understanding of pharmaceutical quality requirements for scalable commercial manufacturing."
Recipharm Advanced Bio has the ability to enable comprehensive and accelerated manufacturing via its network of advanced therapy medicinal products facilities, along with its centers of excellence, in order to support partners from early development through commercial supply.
In October, Recipharm announced the inauguration of newly commissioned parenteral development and sterility laboratories at its Bengaluru, India site, according to the company. The purpose-built facilities are designed to enhance Recipharm’s sterile pharmaceutical development and testing capabilities, expand its analytical services function and build on its established strengths in oral dosage and advanced therapies.