By Monica Heger
This story was originally published Jan. 21.
Beckman Coulter Genomics and UK-based biologics safety testing company Vitrology have announced that they will offer joint services combining Beckman Coulter's expertise in next-generation sequencing with Vitrology's more traditional safety tests.
The announcement follows developments last year in which next-gen sequencing uncovered fragments of a porcine circovirus within a rotavirus vaccine, prompting the US Food and Drug Administration to consider the use of sequencing as a quality-control measure for vaccines and biologics (IS 5/11/2010). The vaccine was ultimately deemed safe because the virus was shown to not be infectious in humans, but the FDA still recommended that the vaccine be temporarily suspended in the US until further safety tests could be performed.
Since then, both Beckman Coulter Genomics and Vitrology said that they have seen an increase in sequencing requests from their customers, which include vaccine and biopharmaceutical companies.
"Our customers were requesting [next-gen sequencing] and the FDA has recommended it," Archie Lovatt, director of scientific operations at Vitrology, told In Sequence. While the FDA does not require the sequencing of vaccines or other biologics, Lovatt said that the agency has encouraged the use of the technology, and he thinks that it eventually will require it, prompting companies to seek those services.
Konstantin Chumakov, the associate director for research at the FDA's Office of Vaccines Research and Review told In Sequence via e-mail that "the new sequencing methods have not been validated yet, so there is still a long way to go before they could become a part of routine vaccine QC tests."
Elena Jouravleva, global product manager for biologics testing at Beckman Coulter Genomics, said that it, too, has seen an increase in requests to sequence vaccines. The two companies have worked together in the past, she said, so the partnership was a natural and logical next step that would allow drug and vaccine manufacturers to get both their sequencing and the required safety tests offered by Vitrology in one stop.
Clients will deal with one representative who will design customized packages utilizing services from each company, based on the project and its requirements, she said. Under the agreement, the companies can sell each others' services, and will potentially expand their customer base, although they are already largely overlapping.
"Our expertise in next-gen sequencing will be complementary with Vitrology's expertise in biologics safety testing," Jouravleva said. Vitrology's services are compliant with good manufacturing practice and good laboratory practice requirements.
Beckman Coulter offers next-gen sequencing services on the Illumina Genome Analyzer, Roche's 454 GS FLX, and Life Technologies' SOLiD.
Jouravleva said that platform choice will be driven by the particulars of the project. For a project evaluating a vaccine vector with many repeat proteins, they will likely use the 454 because of its longer read lengths. However, for projects such as searching for adventitious agents in abundant host material, they will be more likely to use a shorter read platform to take advantage of its higher depth of coverage, she said.
Lovatt said he envisioned a vaccine manufacturer using sequencing services to screen for both known and novel contaminants in the vaccine seeds or starting material. Then, if the sequencing screen turned up anything, it could be further tested with either real time PCR or culture-based technology from Vitrology.
Aside from vaccines, he said sequencing could also be used for drugs being developed for gene therapy, which are often delivered to the tissue via a viral vector.
Financial details of the agreement, including how revenue will be divided and the price structure of different service packages, were not disclosed, and Jouravleva said the agreement would be revisited in six months to see if any adjustments needed to be made.
Even though the FDA does not require the sequencing of vaccines, it has been testing the technology on live viral vaccines, and has evaluated the ability of both the Illumina Genome Analyzer and Roche's 454 GS FLX to identify pathogenic mutations in live polio vaccine (IS 11/16/2010).
While the agency has not purchased a sequencer of its own, it recently indicated it was interested in purchasing a Pacific Biosciences machine (see story, same issue).
Meantime, it has been contracting out sequencing services, and Chumakov has said that he thinks sequencing will become the ultimate tool for monitoring the stability of all viral vaccines, although that is still a ways away.
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