POMPEY, France - Novasep is pleased to announce that its site in Le Mans - France, specialized in the development and manufacturing of Highly Potent Active Pharmaceutical Ingredients (HPAIs), has received the “Potent Compound Safety Certification” from SafeBridge(R) Consultants, Inc.
The SafeBridge(R) Potent Compound Safety Certification program verifies Novasep’s performance in the management, evaluation, containment, control and communication elements of HPAI production operations. SafeBridge(R) Consultants, Inc. conducted a 60-element review of programs, procedures, containment and control of the active pharmaceutical ingredients at Novasep’s Le Mans site. Based on the quantitative results of the Potent Compound Safety Certification program, SafeBridge(R) certified that Novasep meets current industry standards for the safe handling of potent APIs in the identified areas. The certification applies to the R&D laboratories, the kilolabs, a manufacturing scale synthesis area and their associated quality control laboratories.
“The SafeBridge(R) certification demonstrates the know-how, expertise and continued commitment of Novasep for more than 15 years at its Le Mans site in the safe handling of highly potent compounds”, says Rene de Vaumas, Head of the Novasep Synthesis business unit. “In Le Mans, Novasep offers a unique combination of total synthesis, extraction, semi-synthesis and chromatographic purification using Novasep’s own preparative HPLC technologies, for laboratory to commercial scale manufacturing of a broad range of HPAIs, including cytotoxics”, he added.
In addition to the potent compound certification, Novasep has integrated facilities and expertise for Monoclonal Antibody (mAb) production, with the recent acquisition of the Belgian CMO Henogen. Capitalizing on its unique ability to handle biopharmaceutical manufacturing as well as highly potent synthesis and purification, Novasep is now one of the sole CMOs in the world able to provide complete and safe manufacturing solutions for Antibody Drug Conjugates (ADCs), from early development to commercial scale.
Anticancer drug candidates, of which many incorporate cytotoxic compounds, represent the biggest R&D pipeline of the pharmaceutical industry, with more than 1000 products currently in clinical trials. Among them, the Antibody-Drug Conjugates (ADCs) composed of a toxic substance (”payload”) linked to a monoclonal antibody are designed to directly target cancerous cells. This new class of drug candidates are involved in more than 130 pharmaceutical development programs, from biological testing to late phase clinical trials.
About Novasep
Novasep develops, markets and operates innovative technologies providing life science industries with safe and cost-effective production of active molecules.
The global manufacturing solutions offered by Novasep include process development services; purification equipment and systems; contract manufacturing services; and complex active molecules. They apply to:
- Synthetic molecules, combining conventional chemistry with special technologies and know-how such as hazardous chemistry, asymmetric synthesis, HPAI handling, low temperature chemistry, biocatalysis, process chromatography, etc. - Biomolecules, with single unit operations or complete upstream and downstream processes including fermentation and cell culture, innovative batch and continuous purification technologies such as membrane processes, ion exchange, chromatography, crystallization and formulation.
As user of its own technologies, Novasep understands its customers’ challenges and shares its experience and know-how to provide the best solution with guaranteed performance.
The applications of Novasep’s offering cover the pharmaceutical, biopharmaceutical, food, functional ingredients and bio-industries markets.
Customers include pharmaceutical companies such as Pfizer, Sanofi Aventis, Roche, Wyeth, Eli Lilly, Bristol Myers Squibb, GSK Biologicals, Gilead, UCB Pharma.
The company has six FDA inspected manufacturing plants in France, Germany and the Bahamas, two biopharmaceutical production sites in Belgium, R&D and equipment manufacturing facilities in the USA, China and France, and an office in Japan. It employs approximately 1,300 people and had annual revenues of EUR324 million in 2008. More than 2,000 systems designed and produced by Novasep are currently purifying active molecules throughout the world. The company holds more than 300 different patents covering its technologies and processes.
About SafeBridge(R) Consultants, Inc.
SafeBridge(R) Consultants, Inc is the premier occupational health and safety consulting firm to the pharmaceutical, biotechnology and fine chemical industry with offices in Mountain View, CA, New York, NY and Liverpool, UK. SafeBridge has provided the Potent Compound Safety Triangle(TM) of services in industrial hygiene, occupational toxicology and industrial hygiene analytical chemistry to over 400 business units worldwide and is a leader in recognizing, evaluating and controlling exposures to potent active pharmaceutical ingredients and products.
www.safebridge.com
Contact Jean Blehaut, at: +33-383-49-70-99 Jean.blehaut@novasep.com
www.novasep.com
Source: Novasep
Contact: Jean Blehaut, at: +33-383-49-70-99, Jean.blehaut at novasep.com
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