Diagnostics Manufacturing
Biopharma Group offers an extensive range of manufacturing solutions for the diagnostics industry. From small-batch manufacturing to large-scale production, our expert team has the capacity to support projects of all scopes and sizes.
With our flexible production facility, we can tailor our services to your project’s unique requirements. Our facility features three Category D cleanrooms, which enable us to swiftly and safely manufacture your non-sterile formulations at scale. We can also accommodate a host of product formats, including vials, tubes, well plates, bulk strips, cartridges and lyobeads.
Everything that we manufacture is produced in our ISO 13485 accredited facility, providing assured quality control and regulatory compliance. We also offer full packing and kitting services as part of our production solutions – even for non-standard products.
From 2020 to 2022, Biopharma Group produced 2.5 million diagnostic tests per month for the UK’s National Health Service (NHS) during the COVID-19 pandemic.
Our production facility features:
- 15 freeze dryers to provide high capacity
- More than 10m² of shelf space
- Flexibility to run batches ranging from 1 to 150 plates in a single machine
- Production capacity of 96,000 tests per day on a 24-hour cycle basis
- Capability to support mastermixes, RNase inhibitors and positive controls
- A dedicated positive control suite in a separate building
Quality control is at the heart of everything we do at Biopharma Group. All our diagnostic manufacturing services undergo rigorous quality and regulatory checks and are ISO 13485 compliant. 
