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Highly Potent Facility Details |
| Lonza has over 110 years of chemistry know-how and an API development and production track record few contract manufacturers can match. Our experience in producing highly potent APIs goes back over 15 years.
Over the past decade we’ve invested $150 million to build cutting-edge facilities for highly potent drug success. Today, we are able to offer a wide range of advance capabilities, from process development to large-scale manufacturing, with the potential for expansion and improvements to meet customer demand.
At the heart of our high potency capabilities is our Visp, Switzerland, site. Here a dedicated high potency team is able to leverage all of Lonza’s resources for effective and efficient highly potent API manufacturing. |
HPAPI Production Facilities
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• Three multi-purpose trains
-- 2 x 630L
-- 2 x 2,500L
-- 4 x 10m3
-- Target OEL 0.1 – 1 µg/m3
• Scale up from lab to > 500kg per batch
• Hydrogenation capabilities
• Highly motivated and well-trained operators
-– Permanent training
• Concept
-- Isolators
-- Big bags handling
-- Dedicated clean room
-- Cleaning in place
-- Cleaning based on MAC concept
-- Validated cleaning procedures
-- Effective cross-contamination prevention
• Potential expansion reserve (lead time 12-18 months)
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HPAPI R&D Laboratories
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• 4 separate labs for chemical synthesis
• 4 separate labs for peptides and antibody drug conjugates
• Lab-scale production up to 10L
• AHSK4 and AHSK5 (down to OEL 30 ng/m3)
• SafeBridge® certification
• Operating under cGMP
• Concept
-- Glove box
-- Dedicated HVAC system
-- A1 Safetech hoods
-- Laminar flow type work benches equipped with HEPA filters enabling efficient lab work
• Preparatory HPLC / chromatography
• Lyophilization
• Experienced chemists with track record in scale-up and tech transfer from lab to 10m3 scale
• Dedicated, specialized training program
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HPAPI QC Laboratories
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• 2 Dedicated and fully equipped laboratories
• AHSK4 and 5 analysis, solid handling
-- OEL minimal 40 ng/m3
• Methods Available:
-- HPLC / GC
-- ELISA
-- UV
-- TOC
-- Endotoxin
-- Bioburden
-- Osmolality
-- Moisture by KF
-- Turbidity
-- Ion Mobility Spectroscopy
-- Solid state: PSD, TGA, NIR (up to AHSK4)
• SafeBridge® Certified
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