Before manufacturing a biologic product for Phase I through to Phase III, it is essential to set up the base for a robust process development, said Tony Mulcahy, Cobra Manufacturing general manager.
Mulcahy was speaking at Biotrinity, the South East's largest annual biotech business conference held this week in Oxfordshire, UK.
Process development consists of defining and developing a manufacturing process that meets specific requirements of a biopharmaceutical while meeting process quality and cost objectives.
He added that process transfer was also critical and sending a scientific team to the client's facilities to take the information back could help contractors transfer the manufacturing process as smoothly as possible.
During the development of a biomanufacturing process, problems are highlighted by the technology transfer and this gives contractors to chance to fix these problems very early on in the process, said Mulcahy. This can also happen when analytical methods are added to the process, he said.
"Developing the process further enables us to remove non-good manufacturing practice (GMP) compliant steps and provides a more robust process," Mulcahy told the conference.
He added that assay development was also a critical area.
Cobra Biomanufacturing is a UK-based contract manufacturer providing services from gene cloning to cGMP manufacturing for pivotal pre-clinical through to Phase III clinical trials.