SERAING, Belgium--(BUSINESS WIRE)--Eurogentec, a custom service and contract manufacturing company, announced today that its Seraing, Belgium Drug Substance manufacturing facility has recently completed a Pre-Approval Inspection (PAI) by the U.S. Food & Drug Administration (FDA) and that it has been granted "acceptable" status under the FDA's current regulatory guidelines. This FDA status allows Eurogentec to manufacture a commercial bulk parenteral biopharmaceutical for one of its clients for the US market.
Ingrid Dheur, Business Unit Director, says, “We are very pleased with the status we have received from the FDA; this demonstrates our continued commitment to a high level of scientific knowledge, and the strict cGMP compliant manufacturing and quality management system maintained at Eurogentec.”
Jean-Pierre Delwart, CEO, says “We are very pleased with this result and anticipate it as one of several future inspections as we work to bring other products closer to commercialization with our clients.”
About Eurogentec
Eurogentec SA (part of the Kaneka group) is
a contract manufacturing organization providing custom products and
services to researchers in the biological sciences, diagnostic and
biopharmaceutical industries. The company operates under ISO 9001, ISO
13485 and cGMP quality systems. Eurogentec’s two business units fully
support diagnostic and drug development projects from early R&D to
commercial phases.
• The “Genomics & Proteomics” business unit provides custom oligonucleotide, peptide, RT-PCR products, customized polyclonal and monoclonal antibody production and a range of kits and consumables in a variety of scales for basic research to commercial in vitro diagnostics applications.
• The “Biologics” business unit offers contract process development and GMP manufacturing of recombinant proteins, conjugates, plasmids and vaccines for clinical trials and commercial uses. Eurogentec received its cGMP accreditation in 1994 and since then has developed over 80 different GMP processes for clients around the world. Focused on microbial production (E. coli, P. pastoris, etc) Eurogentec offers expertise in protein refolding, periplasmic expression, and protein expression by secretion. Technological offerings include high yielding fed-batch fermentation processes for proteins and plasmids, off-patent pichia expression systems, and protein modifications by chemical couplings (PEG, peptide-protein, etc).
Headquartered in Belgium and with strategically located subsidiaries worldwide, the Eurogentec Group employs a team of 400 people.
About Kaneka
Kaneka is an innovation-oriented chemical
company. Traditionally the company has been active in polymers,
fermentation, biotechnology and electronics, as well as other fields.
Business activities now span a broad spectrum of markets ranging from
plastics, EPS resins, chemicals and foodstuffs to pharmaceuticals,
medical devices, electrical and electronic materials and synthetic
fibers. The life science related activities are currently one of the
strategically important domains for Kaneka. The company has been a
pioneer among Japanese chemical companies in establishing overseas
operations, beginning in 1970 with a subsidiary in Belgium.
Kaneka Corporation is a company headquartered in Osaka-Japan, with subsidiaries in Belgium, the United States, Singapore, Malaysia, China, Australia, Vietnam, India, South Korea and Taiwan. Net sales in the last financial year were 454 billion Yen, corresponding to about 4.4 billion Euro. Kaneka employs more than 8,400 people worldwide.