GenIbet Biopharmaceuticals

GenIbet Biopharmaceuticals

http://www.genibet.com

GenIbet is a biopharmaceutical CDMO (Contract Development and Manufacturing Organization) offering highly specialized microbial, cell culture and viral propagation process development and cGMP manufacturing services to research groups, biotech and pharma companies. This, combined with in-house fill and finish capabilities, gives our clients the opportunity to go from bench to clinic in one facility. GenIbet’s core activity is the manufacture and supply of materials for use in early stage drug development, pre-clinical studies and cGMP manufacturing from Phase I to Phase III clinical trials. Our services include: Process development for biopharmaceuticals; cGMP biopharmaceutical production (drug substance and drug product; cGMP master and working cell bank production; cGMP master and working virus seed stock production; cGMP cell and gene therapy production; Fill and finish; Quality control and quality assurance services.

Role in the TRANSVAC project

Manufacture of GMP master/working cell banks; Manufacture of GMP master/working virus seed stocks; Manufacture of clinical-grade vaccine candidates (drug substance and drug product).

Main staff involved in TRANSVAC

Raquel Fortunato, PhD, CEO; Tiago Ferreira, PhD, Operations and Planning Director;

The Facility

GenIbet offers 1000 m2 of GMP-compliant upstream and downstream manufacturing facilities, including QC labs and R&D facilities, three BSL2 units for the cultivation of bacterial cells (50 L capacity), insect and mammalian cells (50 L capacity for suspension cell cultures, 168,000 cm2 capacity for adherent cells) and the propagation of viruses (50 L capacity, with space to expand up to 200 L). GenIbet has also manual filling capacity of up to 1500 vials with volumes of 0.1 to 100 ml.

TNA or Training provided

GenIbet provides GMP production Services that can be accessed on a pay-per service basis.

Description

Description