Cambrex Nears Completion of Multi-Year, $100-M Small-Molecule API Expansion  

Matt Bio
Chief Scientific Officer 

Cambrex is nearing completion of a multi-year, $100-million expansion in small-molecule development and manufacturing. Matt Bio, Chief Scientific Officer, Cambrex, outlined the company’s recent expansion activity at the DCAT Member Company Announcement Forum held on March 18th, 2024, at DCAT Week. 

Cambrex is nearing completion of a five-year, $100-million-dollar investment project, one year ahead of schedule. The project, which expands the company’s capacity and capabilities across 70% of its North American and European drug development and manufacturing network, will be complete by the end of 2024.

The company’s investments span all scales of clinical and commercial drug-substance development and manufacturing and adds capacity, new capabilities, and advanced technologies Capital projects that have been completed as part of the five-year plan include:

  • The addition of analytical services co-located with API process development, formulation and early-phase drug substance and drug-product manufacturing at the company’s site in Longmont, Colorado.
  • A new high-potency API (HPAPI) lab for process and analytical development in its site in  Milan, Italy, which includes two high-containment isolators.
  • Secure cGMP intermediate supply at its site in Tallinn, Estonia, with a new 160-L reactor train, as well as non-GDP 150-L glass and stainless-steel reactors for kilogram-scale manufacturing of materials for preclinical toxicology studies.
  • A new, 40,000-ft2 stability storage facility in Liege, Belgium, with 35,000 temperature-controlled storage spaces for long-term, intermediate and accelerated stability trials, including 2 – 8°C and 25°C / 60% relative humidity (RH) and 40°C / 75% RH.
  • A 51,00- ft2 R&D buildout at its site in Waltham, Massachusetts, with five GMP kilo-labs, a stability suite, and 24 hoods to support continuous flow and batch process development and manufacturing. The facility is led by Matt Bio, Chief Scientific Officer at Cambrex.
  • 35,500 ft2 of clinical development and manufacturing capacity in High Point, North Carolina, which includes two clinical suites with paired 500-gallon and 200-gallon reactors, a new process chemistry lab with 65 bench hoods and 8 walk-in hoods, a dedicated 4,000-ft2 flow chemistry lab and a development scale-up lab.
  • 15,000 ft2 of small-volume commercial capacity in High Point, North Carolina, including two suites with 500-gallon reactors, one suite with 200/300-gallon reactors, and 0.1 microgram/m3 handling capability.
  • 30% capacity increase at its flagship commercial API manufacturing facility in Charles City, Iowa, with new reactors sized up to 16,000 L and totaling 25,000 gallon (100 m3) of reactor capacity.
  • A 25% increase in flexible API manufacturing capacity at is site in Karlskoga, Sweden, by modernizing an existing production line and commissioning a new, 6-m³ -cale production line.

In addition, the company is focused on completing the following projects as part of its five-year investment strategy:

  • Two additional 6-m³-scale production lines in Karlskoga, Sweden, marking a 50% increase in large-scale GMP capacity at the facility (April 2024); and
  • A 9,000-ft2 expansion and 21,000-ft2 renovation in Charles City, Iowa, which will enhance and modernize the facility’s quality control and R&D capabilities (December 2024).