By CERBIOS-PHARMA SA
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With more than 45 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 Active Pharmaceutical Ingredients (APIs) and High Potency Active Pharmaceutical Ingredients (HPAPIs) product pipeline alongside exclusive third-party CDMO services for APIs, HPAPIs, Antibody Drug Conjugates (ADCs) and recombinant proteins from preclinical and clinical stages to commercial supply. The company supports 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:
Cerbios portfolio covers 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.
Starting from 1993 Cerbios specialized further in development, scale-up and commercial manufacturing of HPAPIs, with a particular focus on Vitamin D Derivatives, (analogues), such as Calcitriol, Calcipotriol/Calcipotriene(anhydrous and monohydrate), and Doxercalciferol. Cerbios is currently expanding its portfolio through the development and manufacturing of Drug Substances used in respiratory inhalation therapies; in particular Tiotropium Bromide Monohydrate, Glycopirronium Bromide and Indacaterol Maleate.
Cerbios has also a long standing experience in the probiotics field. Since more than 45 years Cerbios produces infact in Lugano site its finished pharmaceutical drug based on proprietary strain Enterococcus faecium SF68®, for treatment of diarrhea and dysbiosis by antibiotics.
Due to the unique characteristics of SF68®, starting from 2018 Cerbios decided to investigate new possible applications meant for different therapeutic areas. In 2021 Cerbios finalized the development of two new Food Supplements for the management of ACNE & Seborrheic dermatitis and to boost immune response. Both products are supported by robust scientific evidences.
New products with innovative indications are part of the 2022 pipeline, for management of cholesterol and of IBS symptoms.
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, Payloads, ADCs, 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/Payloads and recombinant proteins to offer CMO services in development and manufacturing of Antibody Drug Conjugates (ADCs).
Within its ADC dedicated division, Proveo (TM), CERBIOS together with its partners AGC Biologics and Oncotec , is providing end-to-end development and manufacturing services for ADCs. Proveo services cover the entire supply chain of an ADC: antibody, payload, conjugation and Fill&Finish offering customers a simplified program management from early development to clinical and commercial manufacturing.
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. A new HPAPI production unit for large batch scale (up to 35kg) resulting in containment level at Category 3 (up to OEL < 30 ng/m3) was lastly approved by Swissmedic in June 2021.
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. In September 2011Cerbios-Pharma SA became the main shareholder of GMT Fine Chemicals SA, a Swiss company (still operating as separate legal entity) founded in 1998 in the industrial area of Couvet in the French speaking region of Switzerland, specialized in the production of reduced folates (Calcium Folinate and Calcium Levofolinate). With such acquisition Cerbios became a worldwide market leader in the supply of reduced folates.