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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
Related services
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
Currently not available