Procos launches high containment HPAPI oncology production to new plant
Press Release | Procos S.p.A.
NOVEMBER 29, 2016
Cameri, Italy: – Leading Italian contract manufacturer (CMO) and Generic APIs manufacturer Procos is launching its oncology-related HPAPI (High Potency Active Pharmaceutical Ingredient) unit into its new 4,000m2 cGMP production facility at Cameri.
The new HPAPI unit will feature some of the highest containment production facilities in the world and will allow Procos to manufacture HPAPIs for the oncology generic market as well as undertake custom synthesis.
The R10 facility has been running at one-third capacity since its completion in December 2015 while it completed a full inspection regime and is now ready to expand to full production.
Laboratories and Production Unit
The oncology Laboratories with its high containment GMP-compliant HPAPI kilo lab and production Suite will occupy the second third of the four-storey facility.
“Additional investment into this building is ongoing and we are working to fill up the last third of it,” said Procos Sales & Marketing Director Kingo Yamashita.
“This second tranche will be fully dedicated to oncology production unit, organized as two main spaces: a GMP kilo lab and a GMP Production Suite for Highly Potent APIs, plus R&D and QC laboratories,” Yamashita explained.
Both laboratories and Production Unit feature very high containment facilities. The production Suite is rated at Occupational Exposure Band (OEB) 4, an occupational exposure limit (OEL) down to 1 microgram per cubic meter (μg/m3). The Kilo Lab is rated OEB 6 with OEL of 0.03 μg/m3.
“This is one of the highest level possible and is only provided by a select few companies in Europe,” commented Kingo Yamashita.
Custom synthesis and Generic HPAPIs
“All of these areas and facilities will be exclusively dedicated to the production of highly potent APIs and will allow us to target custom synthesis projects as well as generic API within the oncological sector,” said Yamashita.
“The QC and R&D labs will be finalized by end of January 2017, ready for lab activity to commence in 1Q 2017,” he added.
Procos plans to finish occupation of the new HPAPIs Production Plant by second half 2017, completing a long term plan to raise overall manufacturing capacity.
Procos S.p.A. is an Italian Contract Research and Manufacturing Organization (CRO, CMO) that specializes in development, scale-up and production of active ingredients and advanced intermediates for the pharmaceutical industry.
Procos is an important member of the international CBC Group, headquartered in Japan. This network provides Procos with global reach, reinforced with subsidiary sales offices in the USA, Slovakia, Germany and India.
Over 70 years, Procos has built up a comprehensive range of technologies and capabilities to provide high quality products and services that have been widely accepted in worldwide pharmaceutical markets. It continuously develops and adds unique generic APIs and key intermediates to its product portfolio.
Procos’ two core business sectors are the development and supply of high potency active ingredients (HPAPIs) and GMP advanced intermediates along with contract manufacturing services.
Procos manufactures more than 30 products, mostly under uniquely designed synthetic methods and under strict regulatory compliance management. In contract manufacturing, Procos provides related services for the pharmaceutical industry acting as a CRO/CMO for custom synthesis on exclusive base, supporting customer from early clinical stage up to full -scale commercial production. Development services include IP analysis expertise and effective patent challenge skills.
Innovation is a driving force of Procos’ activities. The company’s products are based on patented technologies and cost-effective processes. Procos chemistry expertise is focused on the most complex organic reactions, including organo-metallic catalysis, multi-catalytic hydrogenation, Enantioselective and hazardous chemistry.
Kingo Yamashita, Sales & Marketing Director, Procos SpA
Tel: +39 0321 642211
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