Ajinomoto Althea expanding GMP production at California facility

Syringe
Japanese CDMO Ajinomoto Althea is expanding its GMP production offerings at its recently completed high-potency products manufacturing facility in San Diego.

Japanese CDMO Ajinomoto Althea is expanding its GMP production offerings at its recently completed high-potency products manufacturing facility in San Diego.

The plant, which offers process development and analytical services, is scheduled to begin GMP bioconjugation and complex formulation in November, the company said. The new facility is located about three miles from Althea’s current operations. Full operations with the addition are expected to begin by late 2018.

Additionally, the company announced it secured its first manufacturing contract for the new facility. Terms of the deal were not disclosed.

Webinar

Striving for Zero in Quality & Manufacturing

Pharmaceutical and medical device manufacturers strive towards a culture of zero – zero hazards, zero defects, and zero waste. This on-demand webinar discusses the role that content management plays in pharmaceutical manufacturing to help companies reach the goal of zero in Quality and Manufacturing.

“There is limited capacity in the marketplace and customers are eager to secure availability in a state-of-the-art facility,” Jason Brady, Althea’s senior director and head of business, said in a statement.

RELATED: Ajinomoto Althea adding ADC, HPAPI manufacturing with new California plant

The Japanese conglomerate Ajinomoto bought Althea in 2013 for an undisclosed price. The company announced in 2015 it would retrofit its 57,000-square-foot facility to add capabilities to handle bioconjugation, formulation, purification, quality control, and aseptic fill finish including lyophilization.

In recent years, there has been a push by CDMOs to add ADC and HPAPI manufacturing capabilities. Swiss contract manufacturer Lonza announced several years ago a $15.2 million investment 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 purpose. Fujifilm and Indian manufacturer Piramal teamed up to develop and manufacture ADCs as well.

Suggested Articles

The FDA has lambasted the Torrent Pharmaceuticals in a warning letter for making OTC meds using water tainted with bacteria.

Eli Lilly is investing $400 million in its Indianapolis site to expand production of insulin and other diabetes meds, and add 100 jobs.

Recipharm has been building its capabilities in sterile injectable and inhalation drugs. Now it is buying a CDMO that manufactures devices for both.