Facilities at a glance
Eden Biodesign’s facilities support world-class process development, cGMP manufacturing and analytical services for every significant biopharmaceutical and novel vaccine production technology.
Our state-of-the-art licensed facility located in Liverpool, UK is custom designed for multi-product operation and delivers a comprehensive range of services necessary to take novel biopharmaceuticals from proof-of-concept through to cGMP manufacture for clinical trials, market launch and commercial supply.
Facility specifications
- 4100m2 (43,000 sq. ft.) facility
- Fully equipped Analytical and QC laboratories
- Dedicated pilot production process development suites
- Fully segregated cGMP suites designed for rapid, flexible and robust manufacturing of products derived from mammalian, microbial, insect cell and viral production platforms at a range of scales
- Dual generation of clean utilities to provide robust and reliable manufacturing
- Isolators in Process Development and cGMP suites
- Validated independent monitoring system for key equipment with 24 hour service call-out
- UK MHRA Manufacturing Licence for Investigational Medicinal Products
- Custom designed to be fully compliant with EMEA and FDA cGMP guidelines
- All laboratories and manufacturing suites classed as Biological Safety Level 2
Process Development areas
- Segregated pilot production suites in process development to mimic cGMP unit operations and process flows
- Common equipment and control platforms between pilot production and cGMP areas to ensure rapid, successful technology transfer
- Applikon stirred tank bioreactors and fermenters at a range of scales
- A range of disposable bioreactor platforms, including single use stirred tank bioreactors, rocking bags, roller bottles and cell factories
- GE Akta Explorer and Pilot purification systems
- Sartorius Slice and Alpha ultra filtration units
- Niro Homogeniser
- Analytical and process centrifuges and ultra centrifuges
- A wide range of state-of-the-art 21 CFR compliant analytical equipment for in-process and release testing
- Wide range of product-specific bioassay methodologies
cGMP Manufacturing areas
- Scale - Mammalian 200L*, Microbial 100L, Viral 20-100L
- Large, flexible dedicated cGMP suites with ‘plug-and-play’ utility supplies and capacity for additional larger-scale production
- Upstream capacity: Applikon stirred tank bioreactors and fermenters at a range of scales for support of clinical development and market supply. A range of disposable production systems to 100L scale for viral production
- GE Bioprocess and Pilot purification systems
- Sartorius Alpha and Beta ultra filtration units
- 2 x Niro homogenisers
- Centrifugation
- Extensive capacity expansion options
Validated Cryo and ultra-low temperature storage
- 4 x 38,000 vial capacity liquid nitrogen vapour phase units
- 2 x ultra-low temperature freezers with CO2 back-up
- Continuous temperature monitoring through validation
- Independent Monitoring System with automated call out for 24 hour support
*Large scale partner available
