SCM Pharma is to develop and manufacture an injectable neonatal product for BrePco BioPharma to be used in a clinical trial researching the treatment of critically ill premature babies suffering from hypotension.
Ireland-based BrePco selected the development and contract manufacturing organization (CDMO) to initially produce development and clinical batches for eight clinical trial sites across Canada and Europe and then scale-up to commercial production should the product get licensed.
In line with SCM Pharma’s expertise in filling sterile products, this latest vial filling project involves the product needing to be presented as a terminally sterilized vial.
The CDMO has already manufactured engineering batches and will commence work on a stability study with process validation batches next in the project plan.
The product is based on an established and approved inotropic agent. However, the currently approved drugs were developed for adults and are not specifically licensed for use in children.
The aim of the trial is to therefore develop a ready-to-use, licensed treatment for vulnerable preterm infants.
Paul Breen, co-founder and chairman at BrePco Biopharma, said: “With a few years of research already completed on the project, we needed a drug manufacturing partner like SCM Pharma that has a proven track record both in terms of quality and its capability to manufacture products for clinical trials.
“It was vital for us to have a contract manufacturing organization that not only understood the challenges of clinical manufacturing but could also provide the potential to scale up to commercial production when required.
“The project is progressing well and already the SCM team has shown its technical ability and commitment to meet our deadlines and deliver the project to the available budget.”
BrePco along with 12 research partners across Ireland, Europe and Canada led by Cork University Maternity Hospital secured €5.6m from the European Commission's Healthcare FP7 Programme for the project last year.
This was based on hypotension (low blood pressure) being a common problem amongst very premature infants and is often associated with tragic outcomes, including brain injury and death.
At present, the existing licensed product is typically diluted before use depending on the dosage required but involves a challenging administration process, as it is usually needed immediately following birth of a low weight child.
Dianne Sharp, managing director at SCM Pharma, said: “This project with BrePco is a very significant one given the beneficiaries of the product. With our established vial filling capability, we will be working closely with the BrePco team to fast track their project as quickly as possible to help them meet their clinical trial deadlines.”
SCM Pharma is specialist in the global contract drug manufacturing market with its ability to provide cGMP sterile services for C-14 radiolabeling and potent products such as cytotoxics.
The contract filling specialist offers aseptic processing and sterile manufacturing services to pharma companies across the world and along with vials, has specific expertise in ampoule filling and syringe filling of liquids, gels and powders.
At the back-end of last year, SCM Pharma launched its own formulation development capability after acquiring new facilities at the University of Sunderland.
The company now provides developmental services for liquid formulations including emulsions and suspensions for parenteral, oral and topical administration using either proprietary or customers’ novel delivery systems.