CDMO Services

We are a lentiviral vector GMP CDMO offering personalized solutions for ex-vivo and in-vivo administration based on a complete adaptation to customer requirements.

Early-phase development adapted to the requirements of each vector:

Cloning activities: from design to cloning aimed at increasing productivity and conforming to regulatory requirements, among others.
Various tailored optimization activities: from adaptations in producer cell lines, to adjustments in transfection, to different pseudotyping strategies, etc.
R&D manufacture in 2D format.

R&D manufacture in bioreactors.

Manufacture of engineering batches for preclinical phases.

GMP batches for clinical and commercial phases.

Batch release by our own Qualified Person.

Stability studies: long-term and in-use.

Regulatory support including:

Chemistry, Manufacturing and Control (CMC) section of the Investigational Medicinal Product Dossier (IMPD).
Chemistry, Manufacturing and Control (CMC) section of Investigational New Drug (IND).

Comprehensive management of outsourced partners (analytical testing and plasmid manufacturing, among others).

GMP CDMO business model.

Covering the different phases.

Meeting regulatory requirements.

Compliance with EMA and FDA regulations.

Expertise in virology.

We make scalable, cost-effective and regulatory compliant lentiviral vectors.

Customized approach to projets.

Technical adaptation and slots availability in a timely manner.

Ability to adapt to different stages of development.

Scales available for every stage, from early development to commercial manufacturing.

No own pipeline.

Total priority to our customers’ projects.

International company.

Projects in the U.S., Europe, Asia and Australia.

Certificates