Cali OK for Avrio manufacturing plant

By Staff Reporter

- Last updated on GMT

Related tags: Food and drug administration, Pharmacology

US CDMO Avrio Biopharmaceuticals’ new aseptic fill-and-finish facility in Irvine, California has been approved for the manufacture of biologics by state drug regulators.

The firm, founded by contracting group Irvine Pharmaceutical Services in 2008, said that California Department of Public Health, Food and Drug Branch (Cal FDB) clearance for the 20,000 sqft facility completes its portfolio of services.

Initially, Avrio will try and capture a share of the rapidly expanding contract fill-and-finish market for biopharmaceuticals, which most observers predict will continue to grow rapidly as drug makers move away from traditional small molecule production.

The contract development and manufacturing organisation (CDMO) went on to say that, in addition to aseptic fill-and-finish services for biopharmaceuticals, the new plant houses laboratory space, a formulation unit and a pilot plant.

Irvine Pharmaceutical Services’ CEO, Assad Kazeminy was pleased that the new business and facitlity are operational, explaining that: "The addition of Avrio, we can now support our clients from start to finish via a seamless partnership​."

Irvine has been operating since 1988, initially serving as an independent contract testing and chemistry support laboratory for the pharmaceutical and biopharmaceutical sectors

Since then it has gradually extended its portfolio to include a broad range of services including method development and validation, analytical chemistry, stability storage and testing, microbiological support, preformulation and formulation, drug delivery testing, as well as inhalation and nasal testing.

More recently, Irvine began offering biopharmaceutical development services, such as API manufacturing, cell line development, peptides and proteins production as well as the development of dosage forms.

Related topics: Bio Developments

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