New Cambridge facility aims to ease clinical trial supplies challenge
11 Jun 2022
Pharmaceutical and medical manufacturer SMC has opened its new 20,000 sq ft Cambridge Pharma facility, which incorporates a sterile fill-finish facility, process development laboratory and an analytical laboratory.
Services will include process development and scale up, sterile fill finish for clinical trials, QC and stability testing and QP release of clinical trials supplies.
The sterile fill finish facility designed to latest regulatory requirements includes independent HVAC systems and two clean rooms equipped with isolators and fill finish equipment to support batch sizes from 100 units to 15,000 units in vials, cartridges, or syringes.
Industrialisation engineers will apply customers’ laboratory scale formulations and develop a process for clinical trials in phases one to three including process development and filling of viscous formulations, suspensions, and gels. Non-standard primary drug containers can be accommodated, and container closure integrity tests and associated equipment can also be developed.
Commercial director Tim Holden commented: “Our principal aim is to meet the challenging schedules pharma clients face when planning clinical trial supplies. Our process development laboratory means we can support this, it certainly gives us an edge in completing timely technology transfer.
“We have the equipment and facilities designed specifically for smaller flexible manufacturing runs. Specialising in this service ensures that development timelines can be minimised, and cost savings can be made by our customers.”
