1. Plant flexibility Market factors – Flexibility to produce alternative products – Produce multiple products simultaneously Societal trends – Utilization of disposable equipment

2. Plant flexibility Auxiliary downstream equipment – Redundant depth filtration – Redundant ultrafiltration cassette holders Separate rooms – Redundant seed train room – Bioreactors room dividers

3. Good manufacturing practices Provide for proper flow Uncontaminated raw materials Segregated activities Cleanable surfaces Minimization of equipment density

4. Good manufacturing practices Our solutions: ProblemRemedy Cross-contamination Unidirectional personnel flow Segregated activities Contaminated raw materialsWater for injection system Vapor compression distillation Falling film clean steam generation Surface contamination Stainless steel construction Minimization of equipment density Pure product recovery