Ajinomoto Althea adding ADC, HPAPI manufacturing with new California plant

The Japanese conglomerate Ajinomoto gave its biologics manufacturing a shot in the arm several years ago when it bought San Diego-based CDMO Althea Technologies. Now it is building on that play with plans to add a facility capable of handling highly active materials such as antibody drug conjugates (ADCs).

What is now Ajinomoto Althea said Wednesday that it is retrofitting a facility it took over May 1, near its current operations in San Diego. It said construction is already underway on the 57,000-square-foot facility and that it will have the capabilities to handle bioconjugation, formulation, purification, quality control, and aseptic fill finish including lyophilization.

The company expects to be handling some work there beginning in the second quarter of next year and to have "full manufacturing activities coming online the first half of 2017," it said Wednesday in a release. It did not disclose how much it is investing in the new operations.

With oncology therapeutics including ADCs and highly potent active pharmaceutical ingredients (HPAPIs) a big growth area, Jason Brady, senior director and head of ADCs for the company, said in a statement that the operations will add significantly to the "limited capacity of high containment manufacturing in the United States."

There has been a push by CDMOs globally to add ADC and HPAPI manufacturing capabilities. Swiss contract manufacturer Lonza a couple of years ago said it would invest $15.2 million in its plant in Visp, Switzerland, to add to its ADC capacity, while French contract manufacturer Novasep invested about $3.7 million in a plant in LeMans, France, for the same. Fujifilm and Indian manufacturer Piramal have paired up to develop and manufacture ADCs.

- here's the release