Synthon opens ADC plant in the Netherlands
pharmafile | January 29, 2013 | News story | Manufacturing and Production | ADC, Synthon
Synthon Biopharmaceuticals says it has opened officially opened a new antibody-drug conjugate (ADC) manufacturing facility in Nijmegen, the Netherlands.
The plant will help support Synthon’s pipeline of ADC candidates, which rely on the use of anti-cancer antibodies linked to cytotoxic drugs known as duocarmycin analogs, which disrupt cancer cell DNA at any stage of the cell cycle and have potential against multidrug-resistant cancers.
The Dutch biopharma company’s lead ADC candidate HER2-ADC contains trastuzumab – the antibody used in Roche’s blockbuster breast cancer drug Herceptin – and has shown promise in breast and lung cancer xenografts in test animals.
HER2-ADC induced complete tumour remission when dosed as a single-agent therapy in these xenograft studies, and the company now intends to advance the drug into clinical trials in 2014.
“We strongly believe that advancing this second-generation ADC technology will lead to a new class of effective, targeted medicines in oncology,” commented Dr Marco Timmers, Synthon’s chief scientific officer.
“Our GMP plant will also accelerate future patient access to oncology products based on this pioneering technology,” he added.
The Nijmegen facility operates to Good Manufacturing Practices (GMP) and will be able to handle production capacity for Synthon’s ADC candidates through to Phase III testing, according to the company.
Synthon specialises in the development of generic medicines and moved into biosimilars and biobetters in 2007, hitting a milestone last year when it licensed its biosimilar version of Herceptin to Amgen and Watson.
The company has had a manufacturing network for small-molecule generics in place – comprising a mixture of in-house production plants and contract manufacturing partners – but the Nijmegen facility is its first major investment in in-house biologics production.
Phil Taylor
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