Advent Bioservices
Contract development and manufacturing organisation (CDMO) focused on cell and gene therapy. Operates a multiproduct GMP facility near Cambridge (Sawston) providing GMP manufacturing, process development, analytical development, quality control and biobank/ultra-cold storage services. Holds regulatory licences and certifications for regulated manufacture and licensed storage of human cells and tissues.
Industries
Nr. of Employees
medium (51-250)
Advent Bioservices
Services
Multiproduct GMP manufacturing in validated cleanrooms for ATMPs, including clinical- and commercial-scale production.
Process design, optimisation, scale-up/scale-out, automation assessment, and technical transfer to GMP production.
Product characterisation, phenotyping, functional and biochemical assays, assay development and transfer to quality control laboratories for release testing.
HTA-licensed cryostore and freezer facility offering vapour-phase LN2 storage and -20°C to -80°C freezer storage with on-site LN2 generation and 24/7 monitoring.
Validation of cleanrooms, environmental monitoring systems and cold-chain equipment to support GMP operations and regulatory compliance.
Support for meeting HTA, MHRA and other regulatory standards, and operation of GMP/GLP-quality management systems.
Multiproduct GMP manufacturing in validated cleanrooms for ATMPs, including clinical- and commercial-scale production.
Process design, optimisation, scale-up/scale-out, automation assessment, and technical transfer to GMP production.
Product characterisation, phenotyping, functional and biochemical assays, assay development and transfer to quality control laboratories for release testing.
HTA-licensed cryostore and freezer facility offering vapour-phase LN2 storage and -20°C to -80°C freezer storage with on-site LN2 generation and 24/7 monitoring.
Validation of cleanrooms, environmental monitoring systems and cold-chain equipment to support GMP operations and regulatory compliance.
Support for meeting HTA, MHRA and other regulatory standards, and operation of GMP/GLP-quality management systems.
Expertise Areas
- Cell and gene therapy manufacturing
- Biobanking and cryogenic storage
- Process development and scale-up for ATMPs
- Analytical and potency assay development
Key Technologies
- GMP cleanroom manufacturing
- LIMS
- eQMS / electronic batch/medical records
- 21 CFR Part 11-compliant monitoring software
News & Updates
Overview of CDMO services including R&D, process development, QC, GMP manufacturing and cold storage at Sawston near Cambridge.
Participation and presentation on potency assay development and standard setting for cell and gene therapy products.
Exhibited at Advanced Therapies 2024 conference.
Announcement that the Sawston CDMO site received GMP certification from MHRA and approval to manufacture ATMPs.
Announcement of HTA-licensed cryostore and freezer facility with LN2 storage and -20 to -80°C freezers available for client off-site storage.
HSE confirmed clearance for storage of external client GMO material(s) in vapour phase LN2 and freezers (notified activity GM3660/22.1).
Overview of CDMO services including R&D, process development, QC, GMP manufacturing and cold storage at Sawston near Cambridge.
Participation and presentation on potency assay development and standard setting for cell and gene therapy products.
Exhibited at Advanced Therapies 2024 conference.
Announcement that the Sawston CDMO site received GMP certification from MHRA and approval to manufacture ATMPs.
Announcement of HTA-licensed cryostore and freezer facility with LN2 storage and -20 to -80°C freezers available for client off-site storage.
HSE confirmed clearance for storage of external client GMO material(s) in vapour phase LN2 and freezers (notified activity GM3660/22.1).