Biotechnology Unit
Your partner from the laboratory to commercial production
- Transition of production process to GMP
- Process development and scaling
- Equipment selection
- Definition IPCs
- Consultancy GMP (EMA, FDA)
1
Research facilities design
Process development and optimization
2
Pilot plant design
Process Scale Up
3
Process industrialization assessment
Process modelling and simulation
4
GMP production facility design
Basic and detailed engineering
Production equipment selection
Delivering a new therapeutic molecule to the market is a long and complex process that requires involving the right professionals in each step.
Recombinant proteins
Secondary metabolites
Advanced Therapies
(cell & gene therapy)
Vaccines
Monoclonal antibodies
Research facilities design
Klinea has a broad experience in designing facilities for development and research; in recent years Klinea has also succesfully designed facilities for advanced therapies research, including those related to hospitals
Process development optimization
Klinea engineers experience helps its customers to technically and economically optimize laboratory processes; this is essential to avoid facing troubles during scale-up
Pilot plant design & Process Scale Up
Before reaching production scale, it is essential testing processes at an intermediate scale to reduce uncertainty and risk; it is the right moment to carry out transition from lab to production equipment and get real performance data. Klinea works side-by-side with its customers at these project stages.
Process industrialization assessment
Klinea engineering and experts team works to match customer requirements and expectations for market and regulations issues
Feasibility studies
Technical and economic assesment in order to evaluate if a project is viable. These studies are helpful to evaluate projects feasibility to potential investors and to raise fundings.
Process modeling and simulation
We offer modeling and simulation tools and applications to help its customers to achieve a better understanding and control of their processes. These tools are also extremely helpful for production forecast and combining them with AI algorithms can also be used to predict process deviations.
GMP production facility design
GMP are mandatory to ensure that products are manufactured and controlled according pharma quality standards. Klinea GMP professional experts are involved from the beginning of the projects to ensure that designs are according to GMP.
Basic and detailed engineering
The engineering team in Klinea with expertise in different areas prepares the basic and detailed engineering studies to cover all the technical aspects in a project
Equipment selection
Specific equipment is calculated and selected by Klinea engineers, covering from biotechnological/pharmaceutical upstream, downstream, filling, clean and black utilities and HVAC.
