Pre-clinical GLP production services in Mammalian and/or insect (transient or constitutive) expression platforms
Description of service
Infrastructure in its non-GMP development laboratories and pilot scale facility for technical runs and production of preclinical material. iBET will be involved in activities related with GMP-directed evaluation of vaccine candidate production processes, production scale-up for vaccine candidates, definition of specifications for pilot-scale production, product stability testing and delivery for GLP toxicology studies, and evaluation of development, manufacturing and finishing documentation.
2-16 weeks, depending on the expression system (insect/
mammalian cells) and method (transient/stable)*
*Date when the service will be available: From M1 to M42, with 3 months lead time (4UA in first year).
Services do NOT include
Other services available at iBET that are NOT included in the free access:
GMP Analytical Services Unit certified by the INFARMED (the Portuguese medicines authority, EMA Portuguese branch) and by DGAV (the Portuguese veterinary authority) for quality control and batch release of human and veterinary pharmaceuticals, biopharmaceuticals as well as experimental new drugs.
GMP Mass-Spectroscopy Unit that provides state-of-the-art MS services to the scientific community and Industry.
Maximum of 12 products shall be produced and provided to the user.
Sample Requirements - input of users
The user(s) shall contact iBET with at least 3 months lead time to define (1) service(s) to be provided by iBET, (2) expression system and process conditions to be used, (3) analytics to be performed, (4) cost and timelines, and provide all other relevant information.
Regular contacts per email and/or TCs shall be kept with the user(s) to inform about project progression.