Cost Analysis
Start-Up Costs
Pre-launch Costs – Brewing, product design, and estimation. Legal & Regulatory Expenses – Business setup, trademark, patent registration and compliance. Laboratory Organization – Equipment procurement, facility rent, and infrastructure construction. Staffing & Training – Employing researchers, labworkers and front office staff. Marketing & Branding – The costs associated with managing your website, scientific publications, and networking.
Ongoing Production Costs
Materials and Reagents – Purchase of cell culture media, antibodies, and assay kits. Manufacture & Process Development – Operation of bioreactors, isolation methodologies, and quality control. Regulatory- Compliance with the GMP, DUC, product documentation and risk management. Operational Excellence – Adopt practices that help reduce cost such as single-use technologies and process intensification. Supply Chain & Logistics – Distribution, warehousing, and transport of biotech goods.
Scale of Operation
FROM R&D TO COMMERCIAL ACTIVITIES – has the process been validated and is it regulatory compliant? Facility Design & Equipment Optimisation – Cleanroom standards and bioprocessing best practices. Quality Control & Standardization – Standardization of Anti-CTLA-4 molecule production. Strategic Partnerships – Work with pharma companies, research entities and investors to scale up operations.