We guide you through scientific due diligence, identify gaps in your strategy, and work together to create a solid development plan.

We partner with you to identify the right targets—and the right indications—for your unique capabilities and capacity. After all, your development pipeline is the heartbeat of your business.

Together, we design therapeutic strains that are fit for human use, the cornerstone of your innovative journey.

With you, we broaden your synthetic biology platform to meet your needs and to open perspectives.

At your side, we facilitate seamless communication with authorities, investors, and stakeholders who need to fully understand your vision — from concept to product, from biological safety to deliberate release, from regulatory to CMC, IP, legal, and every 'near-impossible' question that may arise.

We can assist your team with scientific inventiveness, problem solving and strategic planning and help you to communicate about it.

Your project's roadmap, from idea to product

Strategic thinking

Compliant manufacturing

Pharmaceutical standards become your standards

We provide guidance and expertise at every step in the development of your GMO Live Biotherapeutic Product, ensuring compliance with pharmaceutical industry standards tailored to each stage of your project.

We support your Chemistry, Manufacturing and Control (CMC) activities, including LBP Drug Substance (DS) and/or Drug Product (DP) design, manufacturing process development, and operational leadership throughout manufacturing and follow-up.

We assist in drafting CMC sections for IND (Investigational New Drug) and IMPD (Investigational Medicinal Product Dossier) submissions, and support communications with authorities, investors, and other key audiences.

We help to develop analytical methods for characterization, QC release, and stability testing of LBP DS/DP — including method development, validation, and tech transfer.

We also support QC release and stability data generation. To enhance and secure your manufacturing process through all clinical stages and beyond. Further, we implement trending analyses across batches.

And finally, we support you throughout QA audits conducted by stakeholders who need a clear and confident understanding of your development strategy.