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Biofortuna Expands Dried PCR Reagents Business Citing Increased Demand from Dx Clients

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NEW YORK (GenomeWeb) — Citing increased demand from companies outsourcing freeze-drying of diagnostic kits, molecular diagnostics firm Biofortuna has expanded its PCR reagent lyophilization production service.

After receiving a £1.3 million ($2.0 million) investment last August to expand its custom service and manufacturing business, the company has now doubled its production capacity and enhanced infrastructure at its Wirral, UK, headquarters.

In an interview with PCR Insider this week, Harry Singh, commercial director at Biofortuna, suggested that the growth in Biofortuna's contract services business, which officially launched two years ago, seems to also be a general trend occurring across the industry. "There are some competitors," he said, "and from what we can tell, the market is growing for them as well."

Companies with molecular tests are keen on creating freeze-dried products because of increased stability and no requirement for cold-chain transport or storage, Singh explained.

Diagnostic kits containing freeze-dried reagents are particularly in demand in emerging markets, he said. Areas that have issues with transportation, temperature control, refrigeration, storage, or power shortages may find freeze dried kits ideal, as they can be stored at room temperature.

Also in emerging markets, where there may be "technical constraints on staff," freeze drying is useful because "they don't have to calculate the mixes and the volumes that they need to add to a tube, all they do is just add their sample," Singh said.

Biofortuna has a number of products in feasibility testing, Singh said. They also have kits now in the market for third parties that are "CE-marked and in formal production" by Biofortuna, as well as a number going through tech transfer from R&D to production.

"What we can tell is that there's really a demand and an appetite for diagnostic providers to freeze dry their mixes," he added.

Biofortuna has proprietary cryoprotection reagents that can be added in the development and validation stage for a particular PCR reaction. The company also makes available its own line of PCR reagents, including real-time hot start mixes, Singh said. "If you have a high glycerol content it's very difficult to freeze dry," for example, and the company's mixes are glycerol-free.

"Quite a lot of what we do is feasibility work up front," Singh said. "We are effectively a group of molecular biologists, and that in itself makes us unique. Some of the other companies, you just give them stuff and they'll freeze dry it and send it back to you. We look at the buffer, the Tris, the pH, the magnesium content, the enzyme, the primer, the probes … we understand diagnostics."

Production of freeze-dried diagnostic kits is done to ISO13485 standards, he said.

In addition to the freeze drying service, Biofortuna continues to offer its own line of molecular assays called SSPgo, which are HLA testing kits.

In 2010, the company raised £1.1 million ($1.6 million) in a Series A round to launch SSPgo, its first diagnostic genotyping product, which it officially unveiled later that year. In 2012, Biofortuna inked a deal for an undisclosed amount whereby Abbott Molecular became the exclusive distributor of SSPgo kits.

The kits have since been CE-marked, and in February they were cleared by the US Food and Drug Administration. "They've just gone to market in the US this year [after] we launched in March. [Abbott is] doing demonstrations at the moment, and in the rest of the world we're picking up sales," Singh said.

"Abbott is a great partner," he added. "We get quite good global access to lots of different labs in different countries."

Biofortuna's expansion — which included acquisition of additional automated freeze drying equipment and climate control units in its facilities — is part of its effort to offer freeze drying to more customers, Singh said.

The cost of the new equipment will be offset by large batch processing, he said. The company also uses automated dispensing of reagents and lyophilizes in situ in the reaction tube, rather than making beads that need to be transferred. In this way "you can bring the price right down so that it becomes reasonable; and that's kind of our model really, to get as many companies as we can to the production stage of our business."

Biofortuna currently has a growing number of clients, but due to confidentiality agreements Singh was not free to name them.

"It's understandable — you don't want people to know who is manufacturing your flagship product, or your kit, and who you're outsourcing it to … We don't really advertise the relationships that we have with other companies, but they are diagnostic companies," he said.

"Going forward we're looking to add to [SSPgo] with potentially a pipeline of other products, but that's still in discussion at the moment with very preliminary initial discussions around that," Singh said.

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