02.03.12
SCM Pharma has entered an agreement with BrePco BioPharma to develop and manufacture an injectable neonatal product for clinical trials researching the treatment in critically ill premature babies suffering from hypotension.
SCM will initially produce development and clinical batches for eight clinical trial sites across Canada and Europe and then scale-up to commercial production if the product gets licensed. SCM has already manufactured engineering batches and will begin work on a stability study with process validation batches next in the project plan.
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. 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.”
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 will initially produce development and clinical batches for eight clinical trial sites across Canada and Europe and then scale-up to commercial production if the product gets licensed. SCM has already manufactured engineering batches and will begin work on a stability study with process validation batches next in the project plan.
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. 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.”
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.”
