Invitrogen brings animal-origin free media formulation to new facility

Advanced Granulation Technology (AGT) media are a dry form of cell culture media in a granular format suited to industrial-scale production applications which Invitrogen can now make in an animal-origin free environment in response to fears such as prion and microbe contamination.

These formulations are used by pharmaceutical companies in the manufacturing of protein therapeutics rather than small synthetic molecules.

Invitrogen's AGT format provides the biotechnology industry with several advantages compared to conventional dry powder media since they are complete and require no supplementation or pH adjustment, thus eliminating procurement, dispensing and process steps, and improving set-up time in large-scale media and buffer preparation operations.

The formulation also substantially improves dissolution rates compared to dry powdered media and greatly reduces the generation of dust, keeping preparation areas cleaner, safer and lessening the chance of cross-contamination.

What is more, the granules dissolve much more quickly than dry powdered media, reducing media preparation time.

So by reducing costs and time involved in materials planning and procurement, quality testing, supplementation and clean up of preparation areas, AGT media decrease total cycle costs while they increase yield.

Under construction for the past year, the new facility on Invitrogen's Grand Island campus has been validated for production of AGT media formulation in an animal-origin free environment and the company says several pharmaceutical and biotechnology clients have already begun receiving material manufactured in the facility.

Invitrogen invested over $9m (€7.1m) in the facility to utilise the 11,000 square feet of existing space on the campus for several functions, including production of AGT media for internal research projects, internalisation of technology for contract manufacturing capabilities and reduction of manufacturing costs.

"The technology used to manufacture this material adds some cost, however other factors including shipping and preparation at the customer sites offset the costs," Bob Burrier, Invitrogen's vce president of R&D in the firm's BioProduction Systems and Services, told In-PharmaTechnologist.com .

"In the end it is competitively priced to both other liquid and powder formats."

Burrier stressed that the fundamental technology behind these products has been used in the food, pharmaceutical, and chemical industries for many years but it is Invitrogen that advanced it to the biotechnology industry.

The company evaluated more than 800 raw materials involved in AGT production and verified that they were free of animal components.

It also created protocols for the manufacturing and production environment, including stringent requirements for staff gowning, contamination controls such as airlocks, irradiation of clothing and tools, as well as separate locker facilities.

The AOF production facility in New York - AOF is a designation indicating none of the components comes from an animal source - solidifies Invitrogen as one of the Buffalo area's largest life science entities with more than 500 local employees.