The addition of single-use technology at the site in Visp, Switzerland is part of a series of expansions, which include the CHF14m ($15.5m) move to double ADC capacity announced in January 2013, spokesperson Constance Ward told Biopharma-Reporter.com.
“This new investment is necessary to continue to support the growing pipeline of novel ADC platforms from our customers by offering them new manufacturing technology with increased throughput,” she said.
For now, the firm is only implementing single-use systems in its clinical ADC manufacturing facility, which makes toxicology lots, early-phase GMP lots and GMP re-supply lots for a number of products currently in clinical trials.
The addition of single-use technology will allow “flexible ADC manufacturing,” Ward told us, whilst reducing potential contamination risks and increasing capacity.
As part of the upgrade, the layout of the plant has been redesigned and the Heating, Ventilation, Air Conditioning (HVAC) systems revamped which, according to the company, has led to a larger ADC production area.
Lonza’s Visp site manufactures Roche’s HER2 breast cancer drug Kadcyla - according to the EMA’s assessment report – and is one of only two ADCs currently approved, by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA). The other is Seattle Genetics and Takeda’s Adcetris.
However, whilst Kadcyla is in trials being investigated for additional applications, this latest expansion “is not for any specific product in particular, but to broaden [Lonza’s] offering to all clients with early clinical stage products,” Ward said,
CMO competition
As pharma companies look to develop the latest generation of oncology drugs, there has been a wealth of investments in ADCs by a number of contract manufacturing organisations (CMOs), including Catalent, Piramel and Carbogen Amcis.
However, Ward says in light of CMO competition for ADC services, Lonza has the full range of development tools available from the manufacturing of antibodies, linkers and toxins through to the conjugation of these components.
“Furthermore, Lonza has validated and commercialized leading ADC products [Kadcyla] on a commercial scale,” she added.