Alter Ego biotech

As experts in bioprocess industrialization, we provide CMC strategy setting up & operational support from pre-clinical stages to product commercialization.

Chemistry Manufacturing Control (CMC)
Scale-up
Tech transfer
Process Validation
Comparability
Cleaning processes
Viral decontamination
Single Use system qualification

PROCESS INDUSTRIALIZATION :
We 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.

PROCESS CONTROL :
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 related to Quality By Design (QbD).
We define optimized Process validation and Product comparability strategies to support clinical batches, tech transfer or PPQ batches

INDUSTRIAL PARTNERSHIP :
We make connections between biotech industry stakeholders by finding CDMO partner and by looking for new industrial applications of technology

CONTAMINATION CONTROL :
We address product contamination risks by designing an adapted Contamination Control Strategy (CCS), by validating cleaning processes and decontamination processes, and by qualifying single-use systems.

COMPLIANCE :
We provide customized GMP training courses to support your quality culture
We evaluate your organization maturity by leading GMP readiness or PPQ readiness assessment

• antibodies
• cellular immunotherapy
• immunomodulators
• Gene Therapy

• cardiology
• genetic diseases
• hematology
• infectiology
• immunology
• oncology
• ophtalmology