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Additional HPAPI Facility Details
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Lonza's SafeBridge® Certification |
• Dedicated and specialized labs in R&D and analytical
• Clean room facility
• Air classified clean rooms
Safety Health Environment (SHE) Compliance
• SHE assessment made by experts in occupational hygiene and toxicology and pharmacology
• Extensive infrastructure for waste management on site
• SafeBridge® certification (2008) for ADC facilities
Quality Assurance
• Fully cGMP-certified sites
• Regular inspections from authorities (FDA, Swissmedic, ...)
• Frequent customer audits
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Extensive Track Record
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click to enlarge |
• Historical expertise in handling hazardous compounds
• Over 15 years of experience of HPAPI manufacturing at various production scales (laboratory to10m3 scale)
• First peptide project in 2008 with AHSK5 classification
• Antibody drug conjugates unit with lab to plant scale experience since 2008 (OEL down to 40ng/m3 of air)
• Currently, active projects with OEL ranging from 5 to 0.04 mg/m3
-- oncology
-- immuno-suppression
-- veterinary
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