Lonza has completed an expansion at its API manufacturing site at Nansha, China, as part of its recent investment to expand mid-scale capacity there. This focused on extending the capabilities and capacity of development laboratories and kilo-scale cGMP manufacturing laboratories for clinical supply of HPAPIs.
Italian CDMO Olon has completed a large-scale high containment production line (OEL < 1 mg/m3) at its Rodano site at a cost of about €10 million. This is part of a planned €27 million it will roll out over 2022-3 that is fully allocated to the expansion of further internal expertise and capacity of high containment production. The new line, which is already operative, enables Olon to produce HPAPIs in batches of 30-250 kg.
Catalent has completed a $10 million expansion in large-scale isolator units at its sites in Malvern, Pennsylvania, and Dartford, UK. These provide advanced containment capabilities for the micronisation of highly potent drug compounds.
CDMO Hovione used CPhI Worldwide 2021 in Milan to announce plans to invest $170 million over the years 2020-2022 to expand both capacities and capabilities at three sites in Portugal, Ireland, and New Jersey. About 300 jobs will be created as a result. These reflect its increasing focus on spray drying, high potency and particle engineering.
Flamma USA, the North American arm of the Italian CDMO, has completed the re-commissioning of the HPAPI suite at its site at Malvern, Pennsylvania, following an “exhaustive qualification” over the past six months. This is meant to be a viable alternative for customers early stage HPAPIs when lead times are long for others.
Merck KGaA’s Life Science business sector has launched ChetoSensar, a technology that improves the solubility of antibody-drug conjugates (ADCs). Over 20% of ADC candidates are terminated in clinical trials because of poor solubility. The company said that this supports it efforts to double its ADC and HPAPI capacity in the near future.
In partnership with Aguettant Pharmarmaceutical, Italy’s Olon Group is to expand and renovate its plant in Mulazzano, which is dedicated to the production by enzymatic transformation. It will install reactors, filters and ancillary equipment, as well as automating and digitalising some steps performed there.