Construction of new cGMP cleanroom will support large-scale viral vaccine and gene therapy projects
Lonza is to expand its viral-based therapeutics business with the construction of a new, state-of-the-art cGMP cleanroom located adjacent to its existing Houston, Texas operations. Construction and validation are expected to be completed early in 2012.
The cleanroom will offer large-scale capacity to support late-stage viral vaccine and gene therapy projects. It will utilise disposable process systems and be able to support production and fill/finish operations of up to 2,000 litres.
Enhanced EU-compliant fill and finish capabilities are in high demand from Lonza’s pharma and biotech customers, the company says. The expansion will also reduce clients’ wait times for cleanroom capacity due to the ability to run multiple cGMP operations simultaneously.
‘We are very pleased with the growing number of opportunities we are seeing in the viral vaccine and viral vector sector,’ said David Enloe, head of Lonza’s viral-based therapeutics unit. ‘This investment only furthers our commitment to a leadership position in this exciting space of new therapeutics and vaccines.’
Today, viral vaccines are being studied closely for infectious diseases such as AIDS, influenza and malaria. The achievable volumes and relative costs to manufacture virally delivered vaccines versus traditional egg-based vaccines makes this field a compelling alternative production approach.
Viral-delivered gene therapy is also a growing market, with many programmes in development for cancer, central nervous system diseases and eye-related conditions such as advanced macular degeneration.
Lonza entered the viral manufacturing business through the acquisition of Vivante GMP Solutions in August 2010. The company has broad experience in preclinical through to commercial scale cGMP production of multiple viral products; its viral-based therapeutics team has more than 15 years of experience in process and analytical assay development and validation, scale-up, cGMP production, product storage and distribution.