UK-BASED contract manufacturing Organisation (CMO), SCM Pharma, has completed a three-year product supply programme with the University of Cambridge for a clinical trial involving patients suffering from rheumatoid arthritis.
Fill/finish specialist SCM delivered this critical phase of the study from its GMP facility, which involved the encapsulation of an active tablet of differing strengths and a placebo for a randomised, double blind and crossover clinical trial. The work also involved packaging and labelling for the study and packing into patient kits with randomisation envelopes.
The Department of Clinical Medicine at the renowned University headed-up the investigator-led project investigating anti-inflammatory effects of an angiotensin-converting enzyme inhibitor, lisinopril, for patients suffering from rheumatoid arthritis.
The charity-funded clinical study is a multi-site project with the trials being undertaken at Addenbrooke’s NHS hospital, a renowned UK hospital that recently hit the national headlines for a high-profile research project that has led to a potential cure for nut allergies in children.
Operating as a centre for excellence in sterile and non-sterile services, SCM caters for clients in the pharmaceutical, bio, medical device and healthcare sectors. Commenting on the successful delivery of products for the study, project lead, Frances C. Hall, university lecturer and honorary consultant in rheumatology, said:
"SCM were very insightful, professional and helpful from start to finish. Even when the project required some documentation changes, they were able to guide us through the process, while being flexible to adapt to the new project requirements.
"As this was the first clinical trial I have personally been involved with, I was very pleased the team at SCM was able to guide us through the project and run this element of the study in a smooth, trouble-free manner. Critically, it was delivered on-time and on budget."
With the trial being carried out with patients suffering from an inflammatory joint disease that can affect the hands, SCM’s experience was essential in ensuring the outer packaging was suitable for the study.
Shirley Dann, managing director at SCM Pharma, explains: "Given that patients involved in the trial could often have arthritis of their hands, we recommended and used tamper evident HDPE bottles, which were child resistant and included ‘arthritis-friendly’ tops."
The studies are now successfully well underway with around 60 patients initially involved in the trial, with the hope that lisinopril will be able to help patients with this inflammatory type of joint disease.
SCM, which provides a range of small-medium scale manufacturing, filling, development and packaging services for clinical trial and commercial projects, worked closely with the University of Cambridge from the onset in getting to grips with the needs of the project, helping subsequently secure funding.
The set-up phase required SCM’s expertise in generating specifications and documentation, originating label design, sourcing and purchasing materials, issuing batch documents and printing labels.
Following production, SCM’s in-house Quality Assurance (QA) and Quality Control (QC) teams analysed the quality of the finished products. The products then secured a Quality Person (QP) release from one of the company’s QPs, before being distributed on deadline ready for the trial.
SCM offers some of the most advanced cleanroom facilities in the UK and recently launched its radiopharma and biologicals’ services to complement its existing aseptic and terminal sterilisation offerings.
The company has two sites in the UK, offering a vast array of bespoke outsourced solutions from its MHRA-approved state-of-the-art manufacturing facility. In addition, the specialist firm provides a range of testing services and technical and quality consultancy to meet its clients’ needs.
