There is an increasing trend towards the application of biotechnology in the development and production of pharmaceutical products, which generates a need for both pilot plant and production scale facilities.
Pilot plants may have dual functions; both for scale up from laboratory bench operations to produce appropriate quantities of material for further research and testing, and for the development of new production materials and manufacture of clinical trial batches. Production facilities also fall into two categories: small scale facilities for the production of highly active agents utilising technologies such as cell culture and genetically modified micro-organisms, and large scale facilities for the production of bulk products (such as vitamins and amino acids).
Such facilities require particular attention to aspects such as safety and cGMP.
Aker Kvaerner has a dedicated team of high quality experienced personnel with wide-ranging experience in all aspects of biopharmaceuticals.
They work with other team members from disciplines such as facility design, construction, building services, GMP compliance and validation. Together, our team can provide advice and execute projects covering aspects including:
- Media and buffer preparation
- Package or custom-designed fermenters
- Batch, fed batch and continuous fermentation
- SIP and CIP systems
- Computer control and process simulation
- Biomass separation
- Product recovery, purification and finishing including ultrafiltration and chromatography
- Laboratory research and evaluation of data
- Purified water, WFI, clean compressed air and clean steam generation and distribution
- Process development and scale-up
- Building layout design and optimisation
- Building services design (including complex HVAC systems)
- Design, construction and operation at pilot and commercial scale
- Sterility testing
- High integrity leak testing (He, SF6)
- Environmental control
- Commissioning and validation
Printable version