Processing of HPAPIs in isolator

Reach Our HPAPI Experts:

highlypotents@lonza.com

Developing Highly Potent Drugs

Lonza has an API development and production track record few contract manufacturers can match.  This is in part due to Lonza's commitment to improving facilities to lead the industry in highly potent manufacturing.  In the past decade we have 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 in process development and scale-up with plenty of potential for expansion and improvements in the future.  Lonza’s facility in Visp, Switzerland offers dedicated and specialized labs for R&D and analytical testing, as well as a highly technical process R&D staff.

 

Features of Lonza’s HPAPI R&D Laboratories:

  • Four segregated labs for peptides and antibody drug conjugates
  • Lab production up to 10L
  • Laminar flow work benches equipped with HEPA filters enabling efficient lab work
  • Preparatory HPLC / chromatography
  • Lyophilization
  • AHSK4 and AHSK5 (down to OEL 30 ng/m3)
  • Four separate labs for chemical synthesis
  • Operating under cGMP concept with dedicated HVAC system and A1 Safetech hoods
  • Experienced chemists with track record in scale-up and tech transfer from lab to 10m3 scale
  • Dedicated, specialized training program

 

Features of Lonza’s HPAPI QC Laboratories:

  • Two dedicated and fully equipped laboratories with minimum OEL of 40 ng/m3
  • AHSK4 and 5 analysis, solid handling

 

Available QC Tests Include:

  • HPLC / GC
  • ELISA
  • UV
  • TOC
  • Endotoxin
  • Bioburden
  • Osmolality
  • Moisture by KF
  • Turbidity
  • Ion Mobility Spectroscopy
  • Solid state: PSD, TGA, NIR (up to AHSK4)