This project has received funding from the European Union's Horizon 2020 research and innovation programme under grant agreement N° 730964.

Designed by European Vaccine Initiative

Description of service

Access to a GLP production platform suited for production of recombinant vaccine candidates in multi-mg range. SSI offers a GMP-directed evaluation of the user's vaccine candidate production process. SSI will be able to scale up bench scale production processes to achieve sufficient amounts of vaccine for the following tasks: characterisation, verification of proof-of-principle data, toxicity studies and development of robust assays.

Timeline 

3–12 months, depending on the maturity of the customer’s process

Contact 

Ida Svahn Rasmussen 

idsr@ssi.dk

0045 32683943

Services do NOT include

Fill and finish and training is not included.

Possible Output

A report on the technical, economical and regulatory aspects of an existing bench-scale process. Drug substance up to the multi-mg range. Drug substance and/or drug product specification. Drug substance formulation development report. Formal stability study, according to the relevant guidelines. Detailed development status including a list of action points to complete the IMPD. Preclinical material generated in a “comparable” process.

Sample Requirements - input of users

The user must provide a described bench-scale process and culture stabs to start up the GLP-production.

Lead Scientist

Ida Svahn Rasmussen

Pre-clinical GLP production services in E. coli and L. lactis 

expression platforms

Paid Service