Life Sciences

Redefining possibilities: PROCOS' commitment to High Potency APIs*

In a rapidly evolving landscape, PROCOS has strategically directed its focus towards continuous investment and sustainable growth. The primary goal of this strategic approach is to deliver unparalleled services and an expanded product range to its customers. 

Following its 2006 acquisition by CBC, PROCOS has consistently dedicated significant investment towards site enhancements. This includes the expansion of Research and Development (R&D) and Quality Control (QC) capabilities, exemplified by the establishment of a stand-alone building dedicated to the Quality Unit. Over the course of a decade, PROCOS has invested over EUR100 million, reinforcing its commitment to excellence. A pivotal development occurred in 2018 when PROCOS ventured into the High Potency Active Pharmaceutical Ingredient (HPAPI) business.

Building on years of success in this domain, PROCOS established a state-of-the-art workshop with cutting-edge R&D and QC laboratories. This facility features two current Good Manufacturing Practice (cGMP) manufacturing lines capable of achieving Occupational Exposure Limit (OEL) as low as 10 ng/m3.


Buoyed by this success, PROCOS is now taking a further stride into the high potency business. An additional investment of over EUR17 million is earmarked for the introduction of two more cGMP small-scale manufacturing lines and dedicated HPAPI milling units. This expansion will elevate PROCOS’ capacity to the highest containment level, with advanced technologies such as high-pressure chromatography, a nanofiltration system and a freeze dryer. The investment also includes unlocking PROCOS’ established technologies for High Potency products. This encompasses the installation of a dedicated autoclave for high-pressure chemistry, along with a jet mill, pin mill and conical mill for micronisation, supporting particle size distribution control requirements. These suites will accommodate reactors ranging from 5 to 100 L, covering batch sizes from a few grams to 1-2 Kg.

This strategic investment aims to boost support in the Antibody-Drug Conjugate (ADC) field, increasing capacity for payload-linker manufacturing to over 25 kg per year. PROCOS is also set to hire experts in this chemistry field. The overarching goal for PROCOS’ HPAPI unit is to emerge as a leading Contract Development and Manufacturing Organisation (CDMO) in Active Pharmaceutical Ingredients (API) and payload-linkers. This involves delivering superior services and a diverse technology portfolio to partners engaged in oncology and immunology research, from early clinical development to commercialisation.

PROCOS remains steadfast in its belief that oncology drugs play a crucial role in addressing unmet medical needs. The company is committed to supporting Biotech and Pharma in their programs within the challenging field of oncology. The High Potency unit expansion was successfully completed in the second quarter of 2023 and has already received full approval from the relevant authorities.


*PROCOS SpA ( is a CDMO specialising in the development, scale-up and production of APIs, advanced intermediates and related services for the pharmaceutical industry. Located in Cameri, Italy, PROCOS provides 155,000 sq m of cutting-edge, multi-purpose plant, fully designed under cGMP compliance, with 560 cu m of reactor capacity. The site is fully audited and approved by the main regulatory authorities, including AIFA, FDA and PMDA. The company provides 360° support to customers, providing the most advanced techniques such as flow chemistry, Quality by Design QbD), automation, etc, to ensure successful development and supply of their API from preclinical to commercial through all the necessary phases.