Recombinant respiratory antiviral now ready
to evaluate a new antiviral drug against respiratory synytial virus
(RSV) - the major cause of pneumonia and bronchiolitis in children.
The investigational drug, ALN-RSV01, is an injectable recombinant (RNAi) therapeutic for the treatment of the highly-contagious RSV infection.
The US biotech firm had recruited Meridian Life Science (MLS) as a contract manufacturing partner to make a clinical infectious inoculum of RSV in its biopharmaceutical facility in Memphis, TN, and production has just been finished.
"The manufacturing process utilised clinical viral isolates and cell culture to generate infectious respiratory syncytial virus for use in human challenge studies," said Dr. Preston Dorsett, vice president of Science and Technology, MLS.
The RSV clinical material is now being used by Alnylam to establish optimal infectious levels in healthy adult volunteers.
"MLS played an important role in Alnylam's ability to undertake an experimental infection study for the development of ALN-RSV01," said Barry Greene, COO of Alnylam.
"This study represents a significant step forward for Alnylam as it advances this program toward generation of human proof-of-concept anti-viral data."
Therapies involving recombinant technologies are increasingly entering the biopharma pipelines and MLS's contract biopharmaceutical manufacturing facility is one of a few that can now produce recombinant proteins and other biologicals on behalf of the biopharma firms undertaking research and development of these new generation drugs and vaccines.
The firm specialises in Phase I and II clinical trials and last year completed manufacturing of a recombinant protein for the National Institutes of Health for use in a Phase I/II clinical trial of a vaccine for parvovirus.
Meanwhile, Cardinal Health, Halozyme, DSM Biologics, SAFC and Dor Biopharma are among a growing number of other firms active in various aspects of this promising new field of biologic drugs.
Cardinal Health says it is experiencing a "robust market" for its patented GPEx cell line engineering technology, and recently attracted the attention of pharma giant Wyeth as well as Trubion Pharmaceuticals.
The US-based firm has recently signed a new feasibility study deal to develop mammalian cell lines for the two firms at its plant in Wisconsin.
Roche has invested $20m in a new technology that it has the potential to dramatically enhance the delivery of subcutaneous drugs by acting like a 'molecular machete'.
The novel technology was developed by Halozyme Therapeutics and is based on recombinant human hyaluronidase (rHuPH20).
According to Jonathan Lim, Halozyme CEO, Enhanze can deliver up to 100 per cent of subcutaneously-delivered drugs into the bloodstream, compared with around only 60 per cent absorption for a typical monoclonal antibody.
