By CERBIOS-PHARMA SA
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With more than 40 years’ experience in the pharmaceutical industry, Swiss-based CERBIOS specializes in the development and manufacture of both chemical and biological active ingredients for its partners worldwide.
Cerbios offers its own API and HPAPIs product pipeline alongside exclusive third-party CDMO services for APIs, High Potency Active Pharmaceutical Ingredients (HPAPIs), recombinant proteins and Antibody Drug Conjugates (ADCs) that it can develop from preclinical through clinical stages to commercial supply.
The company serves customers in Europe, North America and Japan as well as emerging markets in Central and South America, India, China and South East Asia.
Products & Services
CERBIOS product and service offers are based on its impressive track record in developing and manufacturing New Chemical Entities (NCEs) and New Biological Entities (NBEs), together with expertise in scale up and optimization of production processes. These offers are grouped into three streams:
A wide range of drug substances and drug products including reduced folates such as Calcium Folinate (Leucovorin Calcium), Calcium Levofolinate, Folinic Acid, 5-Methyl-Tetrahydrofolic Acid Calcium Salt, Sodium Folinate, as well as other folates manufactured exclusively for customers.
Since 1993 Cerbios has also specialized in development, scale-up and commercial manufacturing of HPAPIs, in particular Vitamin D Derivatives, (analogues), such as Calcitriol, Calcipotriol/Calcipotriene, and Doxercalciferol.
Its drug products are pharmaceutical probiotics based on the proprietary strain Enterococcus faecium SF68®.
Animal Health Products:
CERBIOS offers a range of products for animal feed or veterinary application including probiotic feed additives Cernivet® LBC G35, Cernivet® LBC ME5 PET, Cernivet® LBC M10, Cernivet® LBC M20 plus.
With a long-term expertise in the development and industrial scale manufacturing of APIs and HPAPIs, Cerbios is the ideal partner from clinical to commercial supply of API, HPAPIs, live Biotherapeutics, Proteins and Antibodies. Services offered include Process & Analytical Development, Scale-up and Clinical Supply, Industrial Validation, Commercial Supply, Full CMC Regulatory Support.
Antibody Drug Conjugates
CERBIOS has leveraged the combined experience in HPAPIs and Mammalian Cell Culture to offer CMO services in development and manufacturing of Antibody Drug Conjugates (ADCs).
Within its Division, Proveo (TM), CERBIOS together with its partners Oncotec and AGC Biologics, is able to offer one-stop and end-to-ed development services for ADCs.
Conjugation process is performed in Cerbios cGMP bioconjugation suite.
CERBIOS holds numerous patents related to particle engineering, bioavailability enhancement and continuous flow chemistry. Its R&D pipeline also includes an innovative patented form of recombinant Urokinase (r-UK).
Structure and history
Headquartered in Barbengo-Lugano, Switzerland, CERBIOS is a privately held company.
The CERBIOS name recognizes the 1994 merger of three Lugano-based companies: Cernitin, Bioferment, and Sapec; all three of which had been under the same ownership since the mid 1970s.
Quality, Regulatory and Standards
CERBIOS operates an internal quality assurance system based on FDA, EMA, PIC/S and ICS guidelines.
Its Lugano manufacturing site is GMP compliant and is regularly inspected by partners as well as Swissmedic, FDA, SQS (Swiss Association for Quality & Management System) and Japan’s PMDA. CERBIOS production site has been fully accredited for international manufacture since 2005.
CERBIOS has several approved Drug Master Files (DMFs) active in the USA, EU and Japan and uses eCTD software for electronic submissions.
CERBIOS has developed and implemented an outstanding Management System to provide the framework and tools to manage evolving issues efficiently, while meeting high levels of HSE performance in addition to gaining the satisfaction of both our customers and regulatory authorities.
CERBIOS HSE objectives of prevention of accidents, injuries and pollution and maintenance of world-class performance are achieved through QbD quality design, risk assessment and continuous training.
SafeBridge assessment has confirmed that CERBIOS achieves highest containment level at Category 4 (up to OEL < 10 ng/m3) for both its small scale and batch production HPAPI production units.