Breaking News on Contract Research, Manufacturing & Clinical Trials

Contract manufacturing news in brief

By staff reporter, 05-Feb-2008

Related topics: Analytical testing, QC, Bulk ingredients, Drug delivery, formulation, Fill & finish, packaging, Contract Manufacturing

WuXi PharmaTech, Cobra Biomanufacturing, Scientific Protein Laboratories and IriSys have all recently announced new contract manufacturing news.

WuXi PharmaTech, China's contract research titan, has now completed its first acquisition, gaining biologics capabilities and a base in the US.

 

 

 

The firm paid $151m for US-based AppTec Laboratory Services in addition to taking on $11.7m of AppTec's debt.

 

 

 

Edward Hu, COO of WuXi PharmaTech said: "This is an acquisition of capabilities that we believe will drive our future growth by positioning WuXi as a high quality global drug R&D service collaborator with both small and large molecules expertise."

 

 

 

Cobra Biomanufacturing has entered into a manufacturing development agreement with GenVec, involving its lead product candidate TNFeradeT.

 

 

 

At its facility in Oxford, UK, Cobra will undertake scale-up, and validation of the manufacturing process for the biologic compound, which is being developed as a potential treatment for pancreatic cancer.

 

 

 

"Activities under this agreement will establish a clear path for the submission of the chemistry, manufacturing, and controls (CMC) portion of a biological license application (BLA) for TNFerade as GenVec works towards the completion of our current Phase III clinical trial," said Dr Bryan Butman, GenVec's senior vice president of Vector Operations.

 

 

 

Recently, Alfacell Corporation has initiated a purchase and supply agreement with Scientific Protein Laboratories (SPL) for the commercial production of its lead drug candidate, Onconase (ranpirnase).

 

 

 

The experimental product is currently undergoing a confirmatory Phase IIIb clinical trial as a treatment for unresectable malignant mesothelioma (UMM).

 

 

 

Commenting on the decision to award SPL the contract, Alfacell's CEO Kuslima Shogen said that SPL "has been involved in the production of Onconase from the very first batches".

 

 

 

SPL is a supplier of active pharmaceutical ingredients (APIs) from natural sources, and also provides contract process development and cGMP manufacturing services, including heparin derivatives, natural products extraction, fermentation and purification.

 

 

 

Onconase is a natural protein isolated from the leopard frog, and a first-in-class product candidate from Alfacell's proprietary ribonuclease (RNase) technology.

 

 

 

Meanwhile, GeNOsys (generated nitric oxide systems) has announced that IriSys, the contract formulation firm it hired to assist in the development of its nitric oxide generator portable tablet, has completed the job.

 

 

 

GeNOsys said that IriSys "successfully" formulated the tablets into a product "that could be manufactured in high quantities yet maintain the necessary tablet hardness, appropriate generated nitric oxide concentration and volume."

 

 

Clark Mower, GeNOsys' director said that developing a manufacturing process that could be translated into large scale production, while maintaining the product's quality requirements, was a necessary before the firm could submit the tablet technology to the US Food and Drug Administration (FDA) for approval.

 

 

 

Mower said that the company had now reached a point where it is close to being able to take this next step - all that is left to do now is to customise the tablets for a specific disease.

 

"The completion of the IriSys contract on time and under budget depicts a tremendous success for the company. We are moving rapidly toward a 510 (k) FDA approved device submission", he said.

Copyright - Unless otherwise stated all contents of this web site are © 2012 - William Reed Business Media SAS - All Rights Reserved - For permission to reproduce any contents of this web site, please email our Syndication department copyright@wrbm.com - Full details for the use of materials on this site can be found in the Terms & Conditions

© 2012 - William Reed Business Media SAS - All rights reserved.