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Oligo Factory’s Low-Scale Synthesis Expands Access to Small, GMP-Ready Custom Nucleotides

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Throughout his career, Luke Dannenberg, PhD, has held multiple positions in industry and academia that have put him in close proximity to oligonucleotide technologies. Trained as a scientist, he transitioned into industry roles in 2006 working first at a microarray company that used oligos, which was later acquired by Roche. Over the next 17 years, Dannenberg held leadership positions across Roche Diagnostics, Foundation Medicine, and Dana-Farber Cancer Institute, with a focus on molecular diagnostics and precision oncology.

Now, four months into a new role as CEO of Oligo Factory, he is bringing all of those experiences to bear as the company rebrands its portfolio and expands its offerings for therapeutics, diagnostics, and life sciences.

“Our new tagline [is] accelerating discovery and power and innovation. It’s our commitment to helping biotech companies move faster without compromising quality. It’s to empower these researchers and developers to accelerate the pace of their discovery and develop innovative solutions that are really driving healthcare forward,” Dannenberg told GEN in an interview. “We see a future where we’re partnering with those companies and developers that are developing life-changing solutions.”

Described as a provider of custom DNA and RNA oligonucleotides for therapeutic, diagnostic, and life science applications, Oligo Factory announced that it is expanding its portfolio to include a low-scale oligo synthesis capability at the TIDES USA: Oligonucleotide and Peptide Therapeutics meeting, taking place from May 19-22 in San Diego. The company’s synthesis platform has historically been used to generate customized mid-scale oligos, defined as anything from about 25 mg up to about 100 g, according to Dannenberg. For its low-scale synthesis capability, Oligo Factory will be able to offer quantities as low as 500 micrograms, he said.

The decision to launch a low-scale offering comes down to customer demand. “If you’re a therapeutics developer, the mid-scale is great for late discovery through early clinical trials,” Dannenberg explained. But several customers at different stages of the drug development process have expressed a need for much smaller amounts of oligos than what the company has typically provided. “Expanding to a low-scale allows us to grow with our customers throughout their development journey, whether that be therapeutics or diagnostics.

Alongside its expansion into low-scale synthesis, Oligo Factory has rebranded its custom oligo offerings in ways that it claims better reflect its overall strategic shift. Furthermore, each product portfolio will offer oligos that meet the different quality standards that target customers are required to adhere to. Through the FactorTx
™
product portfolio, the company will offer low- and mid-scale RUO and GMP-grade (ICH Q7) custom oligos to research and development teams working on oligo-based therapeutics. The Factor Dx
™
solution will offer custom oligos manufactured under ISO 13485 standards to support molecular diagnostic assay development and commercialization. Finally, through the Factor LS
™
product, Oligo Factory will provide high-quality RUO-grade (ISO 9001) oligos for developing platforms and life science tools that support PCR/qPCR, next-generation sequencing, in situ hybridization, industrial, and agbio applications.

Part of what has always set the company apart was its rapid turnaround time, Dannenberg said. “We don’t have a product off the shelf. So to make those amounts of oligos at a very fast turnaround time—we’re generally four weeks or less—was one of the unique selling points of the product.” He anticipates that the company will continue to deliver oligos to customers within the same time frame for both low-scale and mid-scale orders. There could be some variation in timing depending on the length of the oligo and the types of modifications that are required. But “generally we’re at four weeks, in some cases we’re delivering much faster than that,” he said.

To meet the demand while keeping manufacturing costs down, the company is considering pre-making some types of oligos that could be used in next-generation sequencing applications, for example. They are also considering pre-making adaptors that will let users run multiple samples simultaneously.

The precision medicine and therapeutics markets are key growth areas for the company, Danneberg said. “There’s a major focus for us to deliver not only GMP oligos, but [also] partner early with those customers through their development phase.” Additionally, there are “interesting angles for oligo uses, whether that be industrial or agbio, [where] our customization and flexibility also gives us an advantage.”

Besides Dannenberg, Oligo Factory has added Baiju Parikh to its senior leadership. Parikh has been tapped to serve as the vice president of commercial. Before joining Oligo Factory, he founded InterpretBio, a consultancy focused on developing market strategies for precision medicine companies, and held senior leadership roles at IBM Watson for Genomics, GenomOncology, and Roche Diagnostics.

In 2023, the company opened a 13,000 square-foot facility in Holliston, MA, that expanded its synthesis capacity 12-fold and boosted its purification and lyophilization capabilities 10-fold. The company has also expanded its manufacturing infrastructure and quality systems to comply with GMP for Active Pharmaceutical Ingredients (ICH Q7) and ISO 13485:2016 compliance for diagnostics.

The post Oligo Factory’s Low-Scale Synthesis Expands Access to Small, GMP-Ready Custom Nucleotides appeared first on GEN - Genetic Engineering and Biotechnology News.
 
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