Although shipments of the two products affected by the quality failures—the pediatric liquid pentavalent combination vaccine Quinvaxem (diphtheria (Corynebacterium diphtheriae), toxoid/tetanus (Clostridium tetani), toxoid/whole cell Bordetella pertussis (DTwP); Haemophilus influenzae type B (Hib) conjugate vaccine; and recombinant hepatitis B virus surface antigen (HBsAg) vaccine; trade name, Hepavax-Gene)—were, as Nature Biotechnology went to press, expected to resume by late November, full production will not be restored until February. Quinvaxem, which protects against five pediatric infections, is the company's most important product, having secured tenders worth $910 million since the end of 2006, including a $110 million order from the New York–based United Nations Children's Fund in May. Crucell has made provision for a €22.8 million ($31.8 million) charge on the inventory lost through the disruption. Even before the problems emerged, the company had been in the process of transferring production of the two vaccines to a new €50 million ($69.8 million) facility in Incheon, South Korea, which is scheduled to become fully operational next year.
Crucell's problems echo those of Shantha Biotechnics, of Hyderabad, India. Not long after Lyon-based Sanofi Pasteur gained an 80% stake in Shantha, the latter firm's Shan5 (DTwP-HBsAg-Hib) vaccine, a direct competitor to Quinvaxem, lost its accreditation on the World Health Organization's (Geneva) list of recommended vaccines because of the appearance of white sediment on vaccine vials. “They've had massive manufacturing setbacks,” says Peter Welford, analyst at Jefferies International, in London. “Crucell [has] had the least problems.” Others competing in this product segment include Panacea Biotech, of New Delhi, India, and the GSK Biologicals arm of London-based GlaxoSmithKline.
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