CMO expansion and deals news round up
Lonza is investing CHF24m ($27m) to add cytotoxic manufacturing capacity at its plant in Visp, Switzerland. Investing in multi-kilogram good manufacturing practice (GMP) cytotoxic capacity adds to gram-scale capabilities to allow Lonza to meet clinical and commercial needs from Visp.
“With the anticipated expansion to be completed in the second quarter of 2012, Lonza Visp will offer a fully integrated end-to-end development and manufacturing solution”, said Stefan Stoffel, head of the chemical manufacturing business unit at Lonza.
Products manufactured at the Visp plant will include highly potent active pharmaceutical ingredients (HPAPI), cytotoxics, peptides and antibody drug conjugates. Once the expansion is complete manufacturing scale-up of these products can occur within the Visp plant.
SAFC is performing process validation, clinical trial supply and commercial production of Reolysin (wild-type reovirus) for Oncolytics Biotech. The work will support Oncolytics as it builds inventory for potential commercial sales.
Gilles Cottier, president of SAFC, said: "SAFC has worked closely with Oncolytics to develop, scale-up, and optimize manufacturing of Reolysin, advancing it to the commercial level."
Canada-based Dalton Pharma Services is providing cGMP aseptic fill and finish services and analytical support to Zafgen, a virtual company from Cambridge, Massachusetts, US. The services will support development of Zafgen’s lead obesity treatment.
"Dalton's expert capabilities in the sterile manufacture of API's and analysis combined with its strength in aseptic filling solidified the manufacturing agreement", said James Vath, head of drug discovery and development for Zafgen.
Shire Pharmaceuticals is using Aegis Analytical’sDiscoverant to manage relationships with contract manufacturing organisations (CMO) by improving data sharing. Technology transfer to and from CMOs, data aggregation, and analysis of paper batch records are supported by the tool.
“Access to data is especially important to improving process predictability, quality and yield when manufacturing sites are geographically dispersed and include CMOs”, said Robert Di Scipio, CEO and president of Aegis.
SynCo Bio Partners is supporting scale-up and manufacture of bulk drug substance and finished product for Syntaxin. The materials will be used in preclinical to Phase II development of SXN101959.
“We aim to establish a long-term relationship with Syntaxin to support its unique TSI (targeted secretion inhibitors) platform and expanding product portfolio, by providing high quality manufacturing and filling services", said Pierre Warffemius, CEO of SynCo.
In an interim management statement Hikma Pharmaceuticals reported US and European growth in its injectables contract manufacturing business. Hikma expects the overall injectables business to deliver “strong organic growth for the full year”.
Althea Technologies is to fill commercial drug products for Biotest Pharmaceuticals. The work will be done at Althea’s commercial manufacturing facility in San Diego, California, US, which opened in 2009, and the products will be sold in the US.
"We are very pleased to be selected by Biotest as their strategic partner and commercial filler”, said Rick Hancock, president of Althea Technologies.