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CPC Biotech s.r.l
CPC Biotech is a producer and contract manufacturing organization (CMO) that specializes in the development and supply of enzymes for Quality Control (QC) for the pharmaceuticals and other industries as well as ready to use media for microbiology.
The company has in-depth expertise in the specialized field of antibiotics inactivation that is crucial for the QC/QA of antibiotics producers and a commitment to genuine innovation.
CPC Biotech is known in the market mainly for its specialization in the development and production of enzymes able to inactivate antibiotics. These enzymes are used in micro QC analysis for sterility testing and total count on antibiotics as well as in environmental monitoring of clean rooms. It was the first company to develop highly stable, broad-spectrum beta-lactamases and is the only company in the world that has developed an enzyme for inactivation of macrolids antibiotics. CPC Biotech is also distinctive in offering heparinases for QC testing of low molecular heparins like enoxaparin.
CPC Biotech offers a range of products and services grouped into two fields.
Enzymes for pharmaceutical and industrial use
CPC biotech enzymes for Pharmaceutical QC include five main products:
- Lactamator™: The leading broad spectrum inactivator of Penicillins, Cephalosporins, Penems and Monobactam.
- Macroduster™: A pioneering and unique solution for Macrolids inactivation.
- Penase:: A specific inactivator of Penicillins.
- Carbamator™/ Carbamator™ Plus: CPC developed a carbapenemase (beta-lactamase) extremely efficient in the inactivation of high levels of carbapenems.
- β-Lactamase CTZ: Specifically active on Ceftazidime, Ceftibuten and Cefepime.
The company also has in late stage of development an enzymatic product for aminoglycosidic antibiotics inactivation that promises to be the first product available in the market for aminoglycoside inactivation.
Media for microbiology
CPC Biotech produces and distributes a wide range of products for pharmaceutical and industrial microbiology.
The previous ready to use (RTU) microbiology media portfolio of Neomed srl has been leveraged by CPC Biotech, with the ability to add its own developed enzymes.
This has allowed CPC Biotech to expand the microbiology portfolio to include sterile liquid and agar-based soils to be used mainly in the pharmacological environment for sterility testing, total count and environmental monitoring.
It also offers RTU media specifically indicated for microbiological analysis of water and surfaces.
Company history and structure
CPC Biotech srl was founded in 2006 with a core mission to develop and produce enzymes for QC, mainly for the pharma sector but also for use in food and beverages, clinical chemistry, etc. The company qualified for ISO 9001 quality certification in 2009 and in the same year registered Lactamator as its trade mark. , signing an exclusive agreement for the use of this product with Heipha Dr. Müller, the Merck Millipore brand for high quality culture media for microbial diagnostics, environmental monitoring and sterility testing.
In 2018 CPC Biotech’s acquisition of Italian-based Neomed srl marked its expansion into the production of ready to use media for microbiology, particularly for the pharma industry. The new business was a synergistic fit, with CPC enzymes added to microbiology media for specific applications.
In 2012, CPC Biotech moved into a purpose-built production facility.
During 2015, CPC signed a further licensing agreement with Merck Millipore for the use of Lactamator and also trademarked Macroduster as a pioneering product for macrolide antibiotics inactivation.
During 2019, CPC has commenced building of a new facility for the production of ready to use media for microbiology.
CPC Biotech has two plants located around Monza. One plant is dedicated to enzymes development and production, the second on is dedicated for media for microbiology manufacturing.
A series of agreements with international distribution partners allows CPC Biotech to market its products worldwide.
Quality, Regulatory and Standards
CPC Biotech is fully quality certified to ISO 9001 standards, with a QC system that meets GMP standards, emphasizing traceability, selection of high quality source materials and personnel training.
Its facilities are modern, with the enzyme facility purpose built and equipped in 2012 and a brand new microbiology media production plant due to come on line during 2020.
Both plants boast state-of-the-art equipment.