Paullo, Italy (25km southeast of Milan)
APIs and advanced intermediates
Cambrex Profarmaco, Cambrex’s Milan facility, is a cGMP manufacturing facility located 25km southeast of Milan, Italy. The facility manufactures small-molecule active pharmaceutical ingredients (APIs) and advanced intermediates for the pharmaceutical industry.
The site has a long history of cGMP manufacturing that extends back over 45 years. The facility manufactures a broad portfolio of products, including over 70 APIs and intermediates.
Cambrex has continually invested in the Milan facility since its acquisition. Most recently, capital expenditures included a new world-class cGMP-compliant API purification and finishing facility and state-of-the-art warehouse facilities.
The warehouse is equipped with automated conveyors and barcode scanning to minimise labour costs, improve inventory control and enhance cGMP compliance.
Cambrex Profarmaco was founded in 1946 in Milan and originally called Industria Chimica Profarmaco. Manufacturing operations were shifted to the Paullo facility in 1962. The site was officially named Cambrex Profarmaco in 2002.
The manufacturing complex is located in Paullo on a 13 acre site. The facility has seven multi-purpose manufacturing areas, a three-stage biological wastewater treatment facility and an onsite incinerator. A full-scale pilot plant plays a key role in the scale-up and optimisation of manufacturing processes prior to full-scale commercial production.
Pilot scale experiments help guarantee process safety, verify product quality and confirm estimated manufacturing costs for commercial production processes prior to initiation of full-scale manufacturing.
The manufacturing capabilities consist of 69 reactors including stainless steel, glass-lined and Hastelloy vessels. Product isolation is carried out with 22 centrifuges of varying sizes and materials of construction.
There are 11 dryers and multiple production trains in the facility. Cambrex Profarmaco is well equipped to handle a wide range of small-molecule API development and manufacturing services.
The pilot plant has 14 reactors with materials of construction including stainless steel and glass lined to accommodate a wide variety of manufacturing processes. It is equipped with three centrifuges for product isolation.
Capacity and manufacturing
The total capacity available at the site is 265m³ with reactor size ranging from 1,300 to 12,000l.
The pilot facility is equipped with 10m³ total capacity with reactor sizes ranging from 100 to 1,000l.
The Milan facility manufactures small-molecule APIs for a wide variety of therapeutic areas including pain management, gastrointestinal disorders, central nervous system, cardiovascular, vasodilators, endocrine and respiratory indications.
Environment and safety
Cambrex Profarmaco is committed to safeguarding the environment along with protecting the health and safety of its employees. To minimise air emissions, the facility has scrubbers that mitigate the gaseous emissions from manufacturing processes. Emissions from the scrubber tower are sent to the onsite incinerator for processing.
The incinerator is utilised for the disposal of waste solvents and process wastes generated during the manufacturing processes. The wastewater treatment facility handles process aqueous streams generated during manufacturing operations.
The company is a participant of the Responsible Care initiative. Responsible Care is a worldwide initiative that demonstrates the global chemical industry’s responsibility toward the environment and the health and safety of its employees.
To ensure the safety of employees and to protect the assets, Cambrex Profarmaco has all the necessary safety equipment including fire suppression systems, a fire truck and onsite power generation.
Cambrex’s headquarters are located in East Rutherford, New Jersey. Founded in 1981, Cambrex Corporation is a leading life sciences company that provides APIs and services to the pharmaceutical industry.
In addition to the Milan facility, the company has two cGMP manufacturing facilities located in Charles City, Iowa and Karlskoga, Sweden that, in addition to custom API development and manufacturing, supply controlled substances (Schedule II-V), high potency active ingredients, taste-masked APIs and high-energy compounds.