Case Study: Design of HPAPI Biomanufacturing Facility

Problem: Over-engineering costs a lot; however not meeting regulatory requirements costs much more. Target: To design a facility for biopharmaceutical HPAPIs that is: 1- Effective and comply with US & EU GMP and EHS regulations. 2- Efficient saving in both CapEx & OpEx. Methodology: 1- User requirements specifications. 2- Obtain BSLs for cell lines will be used. 3- Obtain and analyze products' toxicological data to estimate OEL & PDE. 4- Analyze process steps. 5- Conduct process closure analysis. 6- Apply quality risk management tools, eg: FMEA to assess different risks at different process steps. 7- Decide technical & procedural controls that are capable to reduce risks to an acceptable limit. 8- Cross check against EHS risk assessment to ensure that they are also controlled. 9- Decide primary and secondary containment measures based on risk assessment. 10- Reflect these controls on facility design & equipment URSs. 11- Verify suitability of chosen controls by quantitative risk assessment measuring carry over on equipment and residues in & outside production areas.