SCM Delivers for University of Oxford
Fill/Finish specialist SCM Pharma has successfully completed a fast-tracked aseptic processing project for internationally-famous academic institution, the University of Oxford.
The project team at the university’s Clinical Biomanufacturing Facility approached the UK-based contract manufacturing organisation (CMO) with a requirement to wash, depyrogenate and aseptically process a batch of 2000 2ml vials using isolator technology.
Following the aseptic processes which took place in a sterile isolator located in one of SCM Pharma’s GMP-compliant grade C cleanrooms, the vials were specially packed using suitable packaging materials, QP released and delivered to the University of Oxford for use in upcoming clinical trial projects.
This is the latest high-profile university the CMO has worked with having assisted a number of universities on various sterile and non-sterile projects over the past few years, most notably, a clinical trial project last year with the University of Cambridge.
Ian Pardo, quality assurance manager at the Clinical Biomanufacturing Facility, University of Oxford, said: “We were instantly impressed with the approachable, friendly and knowledgeable nature of the team at SCM Pharma.
“When the project faced some challenges, their team kept us informed and up-to-date with the status of the project timelines. More importantly, having rejected the initial batch due to a quality issue, this filled us with confidence in the sense that this was a CMO with robust quality systems that would not release a batch unless the product was 100% right.
“The products delivered were great and overall, we had a very positive experience dealing with SCM Pharma. We have already recommended their services to other industry contacts and are looking forward to working with them on a regular basis in the future,” added Ian.
The project with the University of Oxford highlights the more straightforward work SCM Pharma is involved with and contrasts hugely from the vast majority of its projects that involve novel, difficult and dangerous drugs, devices and processes.
Its more specialist service offerings include short-run GMP filling of highly potent products, radio-labelled compounds and biologicals, aimed specifically at clinical trial and low volume commercial product supply.
Mike Parry, business development manager at SCM Pharma said: “We thoroughly enjoyed working with the team in Oxford and were delighted to be able to deliver their products to assist with their clinical project requirements.
We are very much looking forward to working with the University of Oxford for many years to come to help meet its clinical trial manufacturing, filling and packaging needs,” added Mike.
Aside from academic-based healthcare projects, most of the work at SCM Pharma involves assisting clients in the pharma, biotech and medical device sectors.