SynCo has a well-established process and analytical development team (APD) ready to collaborate with you on the development of your biopharmaceutical.
Our philosophy is to ‘plan for success’. This means that we do not simply develop a process that will work at the scale of production required for Phase I clinical trials, but we will focus on your long term goals and plan with these in mind. This essentially means that we will develop a process with the eventual commercial scale in mind and scale-down to fit your early phase clinical requirements in the shortest possible time.
Our success in doing this has been repeated time and time again, with the development of processes for multiple biopharmaceutical products that later were licensed successfully.
Our APD team’s experience includes:
- Fermentation development for a wide range of bacteria, including Escherichia coli, Neisseria meningitidis and Lactococcus lactis. This experience enables us to handle a wide range of microbial production systems.
- We are also capable of advising you on the expression system options that should enable you to meet the production challenges of your particular protein of interest
- Cell culture development using Wave bioreactors. Our experience includes working with CHO and PerC6® cell lines to produce a range of proteins
- SynCo currently has multiple 2L, 20L and 200L Wave systems available in its development labs. This enables full scale-up in a development environment, prior to entering the GMP facility, saving you both money and time
- Purification development for recombinant proteins, antibodies and polysaccharides
- Specialist experience in live-biotherapeutics. This involves the development of scalable and closed production systems. As a world leader in this field, we are able to offer both bulk drug substance and final product production (aseptic liquid filling and lyophilization) within our facilities in Amsterdam
If you are interested in learning more about SynCo's Process and Analytical Development services, please do not hesitate to contact us or to Download our Factsheet