Will develop and manufacture an injectable neonatal product
Dianne Sharp says the firm will work closely with the BrePco team to fast track its project to help the firm meet its clinical trial deadlines
SCM Pharma is to develop and manufacture an injectable neonatal product for Cork, Ireland-based pharmaceutical firm BrePco BioPharma to be used in a clinical trial researching the treatment of critically ill premature babies suffering from hypotension.
BrePco selected the UK-based development and contract manufacturing organisation (CDMO) initially to produce development and clinical batches for eight clinical trial sites across Canada and Europe and then scale-up to commercial production should the product be licensed.
In line with SCM Pharma’s expertise in filling sterile products, in this latest vial filling project the product needs to be presented as a terminally sterilised vial. The CDMO has already manufactured engineering batches and will next begin a stability study with process validation batches.
The product is based on an established and approved inotropic agent. However, the currently approved drugs were developed for adults and are not licensed for children. The aim of the trial is therefore to develop a ready-to-use, licensed treatment for vulnerable preterm infants.
Paul Breen, co-founder and chairman of 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 organisation 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 in very premature infants and is often associated with brain injury and death.
Dianne Sharp, managing director at SCM Pharma, said: ‘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 a leading specialist in the global contract drug manufacturing market with its ability to provide cGMP sterile services for C-14 radiolabelling and potent products such as cytotoxics.