Lonza announced today investment plans for technology and facility improvements to its Antibody Drug Conjugate (ADC) clinical manufacturing facility in Visp, Switzerland. The planned upgrades include the introduction of single-use technology for flexible ADC manufacturing, along with a recently optimized plant layout and revamping of the Heating, Ventilation, Air Conditioning (HVAC) systems, which has resulted in a larger ADC production area. The addition of single-use manufacturing systems will reduce potential product contamination risks and allow for increased manufacturing capacity of existing and novel ADC platforms. Currently, Lonza’s clinical ADC plant in Visp produces toxicology lots, early-phase GMP lots and GMP re-supply lots to support ongoing clinical trials for several different product candidates.
Oncology therapeutics represents one of the fastest-growing segments of the pharma and biotech industry, and the deployment of ADC targeted therapies has intensified in recent years. This growth has led to an increased clinical pipeline, which necessitated the expansion of manufacturing capacity and the utilization of new single-use technologies.
ADC cGMP manufacturing facilities must be designed to handle both biological species and highly potent cytotoxic small organic molecule drugs. Since 2010, Lonza has validated large-scale commercial manufacturing of platform ADC technologies primarily utilized by ADC drug developers in conjunction with novel linker/payload platforms. The ADC facilities underwent a successful FDA Pre-Approval Inspection (PAI) in October 2012.
“We have witnessed significant growth in the early-phase ADC market in the last two years,” said Stefan Stoffel, Senior Vice President of Operations for Lonza’s Pharma&Biotech segment. “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.”
The facility re-design was already completely this spring over a seven-week period and will allow for greater flexibility in new clinical ADC product introduction. The second wave of single-use technology adoption and qualification is underway and will ultimately reduce cleaning and changeover times between manufacturing campaigns.
The Visp site will continue to offer integrated end-to-end development and manufacturing of ADCs, including the cytotoxic small organic molecules used in these products and all associated analytics. All current operations will continue without interruption.