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Non-GMP protein manufacturing

GTP’s unique combination of expertise, manufacturing capabilities, flexibility and quality is perfectly suited to protein programmes that do not require production under cGMP environment.

We are dedicated to meeting your needs for supply quality, consistency and timelines

GTP is the ideal partner for your non-GMP protein development programs

For recombinant protein development programmes that do not require manufacturing under GMPs, you might find it challenging to identify a service partner with the right combination of industrial capabilities, rigour and expertise together with the flexibility and costs expected from a light structure.

Most GMP compliant CMOs have a constraining and heavy structure, ill-suited to customisation and lacking pricing options suited to lighter projects. When it comes to manufacturing, most academic platforms and CROs appear limited in capacity, industrial expertise or quality management.

Purposely positioned as a non-GMP CDMO, we are well suited for projects that do not require full GMP compliance. As such, we are entrusted by diagnostic, biopharma and other biotech companies for the supply of their antigen or antibody reagents for diagnostic and analytical assays, protein-based ancillary reagents for cell and tissue therapies and protein reagents for innovative technology tools.

Our capabilities and quality management system are perfectly suited to meet your non-GMP manufacturing needs

We have a substantial and diverse experience in recombinant protein manufacturing with all classical microbial, mammalian and insect cell expression systems, including E. coliP. pastoris, CHO, HEK, Sf9. Our facilities host a range of pilot scale fermenters, bioreactors and downstream equipment scaled for decagram batches. 

We also offer a comprehensive range of characterisation methods and competencies in analytical development, early stage formulation and stability studies, to build a customised package for your molecule.

We understand that when GMP compliance is not mandatory, projects still require a level of documentation that supports the process and product consistency. Our quality management system provides process controls and traceability consistent with the highest standard practices of most industries. While clearly inspired by GMP guidance, we are free to adapt our practices and offer to best fit your demand for rigour and flexibility.

 

Non GMP manufacturing 1 P. pastoris