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

Cost coverage opportunities

If you are interested in this service please contact the service provider directly

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

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