Contract manufacturing news in brief

Related tags Clinical trial Smallpox

In-PharmaTechnologist provides its periodic round-up of new deals
and developments in the pharmaceutical contract manufacturing

UK biotechnology company Acambis​ has acquired a US-based fill/finish facility from contract manufacturing organisation BioReliance, a wholly owned subsidiary of Invitrogen, for $7.5 million (€5.8m). Acambis said it intends to develop a commercial-scale fill/ finish capability suitable for many of the vaccines in its development pipeline. Worldwide, there is a very limited capacity for fill/finish of live, viral vaccines, and BioReliance was one of only two commercial contract manufacturers filling live, viral vaccines in the US.

The facility was completed in 2000 and is designed to produce liquid or lyophilised (freeze-dried) pharmaceutical goods at a scale sufficient for clinical trials. Acambis is planning to undertake a $4-$6m expansion programme to bring the facility up to commercial scale.

Novavax​ has restructured its contract with Cardinal Health​ for the manufacture of its Estrasorb topical emulsion for oestrogen replacement therapy, in order to cut costs. Under the new terms, Novavax will manufacture the product, and Cardinal Health will be responsible for the fill- finish operation.

Two European CMOs, SynCo Bio Partners​ of the Netherlands and the UK's Cobra Biomanufacturing​, have formed an alliance to manufacture plasmid DNA for Phase III trials and commercial supply. Under the terms of the agreement, SynCo has acquired the license to Cobra's intellectual property rights in the pDNA manufacturing process. Cobra will continue to offer preclinical, Phase I and Phase II pDNA manufacture.

SynCo has also announced a major expansion and upgrade of its biopharmaceutical production facilities in the Netherlands, aimed at boosting its development and manufacturing capacity for recombinant proteins and vaccines in Europe. The improvements will focus on lyophilisation, vial filling and capping to double throughput in response to growing customer demand to 3,600 units per hour. Building works are due to start in June, with completion and validation in July and August. The first customer projects are due to enter the facility in September.

Meanwhile, Danish infectious disease specialist ACE BioSciences​ has signed a deal with SynCo for the production of its lead product, ACE 393, claimed to be the first commercial vaccine for traveller's diarrhoea caused by campylobacter. According to the Danish firm, the annual global market for such a vaccine is estimated to be $300m.

SynCo is responsible for delivering the initial vaccine for ongoing preclinical testing this year and clinical-grade material by the end of the first quarter of 2006, the groups said.

The US Department of Health and Human Services​ has awarded a $123m contract to BioPort Corp​ for the manufacture and delivery of 5 million doses of Anthrax Vaccine Adsorbed (AVA), a licensed anthrax vaccine. The supply is being purchased under the US Government's Project BioShield programme, aimed at countering the threat of bioterrorism.

ViRexx Medical​ has signed an agreement with Protein Sciences Corp​ (PSC) for the manufacture of a vaccine for hepatitis B virus called HepaVaxx B, due to start Phase I clinical trials in the third quarter of this year. The vaccine will be made using PSC's Baculovirus Expression Vector System (BEVS) technology.

Life Therapeutics​ of the US has been awarded a contract by DVC​ to provide the vaccinia hyperimmune plasma used to make vaccinia immune globulin (human) (VIGIV), used to treat rare serious reactions that sometimes occur with smallpox vaccination. The hyperimmune plasma will be supplied by Life Sera, an Atlanta, Georgia-based division of Life Therapeutics. DVC is contracted by the US Department of Defense Joint Vaccine Acquisition Programme to produce VIGIV. This contract is worth up to $1.6m to Life Therapeutics.

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