A wise plan as a starting pointWe support our client in building and executing appropriate industrialization roadmap from lab-scale to manufacturing scale.
We identify, select and assess relevant technologies to support Process Scale-up or Tech Transfer.
Success by Design
We provide methodologies required for Product (QTPP, CQA) & Process (CPP, KPP, nKPP) characterizations and related Process Control Strategy as expected by ICH Q8 and ICH Q11.
We define optimized Process validation and Product comparability strategies to support clinical batches, tech transfer or PPQ batches
Technical & cultural bridges
We make connections between biotech industry stakeholders by finding CDMO partner, by looking for new industrial applications of technology …
For a safe manufacturing processWe address product contamination risks by designing an adapted Contamination Control Strategy (CCS), by validating cleaning & decontamination processes, and by qualifying single-use systems.
Objective perspective before decisive milestones
We evaluate your organization maturity by leading GMP readiness or PPQ readiness assessment