Goodwin Biotechnology has started process development work on a monoclonal antibody that will be used by client Q Therapeutics to purify its lead cell therapy product.
Q Therapeutics is developing the cell therapy based on neural glial cells - dubbed Q Cells - to repair neurons that have lost the myelin shealth that surrounds them. Demyelination of nerve cells is a feature of diseases such as transverse myelitis, multiple sclerosis, cerebral palsy and spinal cord injuries.
Goodwin's contribution to the development of the therapy will be to make an immunoglobulin M (IgM) that will bind to a market on the surface of neural glial cells. The IgM will be used in a purification step as part of the manufacturing process
Q Therapeutics hopes to begin Phase I trials of its Q cells in the treatment of transverse myelitis, a rapidly paralyzing subset of multiple sclerosis (MS), in 2009.
SynCo Bio Partners of the Netherlands says it has completed the manufacture and release of ActoGeniX' drug substance AG011 for use in a Phase II clinical trial with ulcerative colitis patients due to start in this summer.
The protein-based biopharmaceutical can be orally administered and has previously been successfully tested in a Phase I clinical trial involving patients with Crohn's disease. A Phase II trial in Crohn's is also scheduled for 2009.
SynCo developed and scaled up the manufacturing process involving cultivation, purification and lyophilisation of AG011.
Pierre Warffemius, SynCo's CEO, said the completion of the contract on schedule "is a clear endorsement of our growing reputation for manufacturing live biopharmaceuticals."
UK contract manufacturer Cobra Biomanufacturing has won a new contract to produce a plasmid DNA-based treatment with Korean company ViroMed. VM206 is being developed to treat tumours expressing Her2/neu, including breast, ovarian, pancreatic and stomach cancers.
Under the agreement, Cobrabio will produce ViroMed's Master Cell Bank and GMP-grade VM206RY for clinical trials which will be carried out in Korea and in the US. ViroMed is Cobra's first client in Asia. In animal studies, administration of VM206 could suppressed tumour growth and prolonged the life in a mouse model of breast cancer.
The announcement prompted an upgrade for Cobra from financial analysts at Seymour Pierce, who said the firm was recovering from a challenging period in the second half of 2007. Cobra lost a manufacturing contract to produce two HIV vaccine candidates for GlaxoSmithKline Biologicals in May 2007.
Atlas Group of India has signed the first contract manufacturing contracts for its new facility in Haridwar, Uttarakhand, including one with leading Indian drugmaker Cipla, according to executive director Aswin Kapur. The company's Atlas Laboratories and Pharmaceuticals unit claims the plant is one of the largest in Northern India.
It has already invested over 100 crores ($23.3mm) in this plant and "a further investment to the tune of 400-500 crores is in the pipeline," said Kapur.
The company is aiming to achieve revenues of 500 crores in the next five years, with the bulk coming from the sale of generic medicines and other healthcare products. The contract business is seen as a way to make use of capacity "and to reach breakeven faster on the project," said Kapur.
