Nucleic acid manufacturing firm Hongene has partnered with contract development and manufacturing organization (CDMO) ReciBioPharm to provide gene editing services to customers, supplying plasmid, messenger RNA (mRNA), and single-guide RNA (sgRNA) used in lipid nanoparticles (LNPs). The CDMO will manage key components of the supply chain and seek to streamline manufacturing and development processes. 

A spokesperson for ReciBioPharm told BioProcess Insider that Hongene will provide the former company with fragment oligonucleotides, which will be joined together using ligase to produce full-length sgRNA that will be purified for assembly into gene-editing drugs.

Manufacturing services will be performed at ReciBioPharm’s Watertown, Massachusetts facility with the possibility of expanding into the company’s greater network of facilities in the future.

The collaboration began more than a year ago when Hongene visited the Watertown site to explore collaboration opportunities. “We are aligned in striving to make sure that customers get the highest quality at reasonable prices,” the spokesperson said. “Hongene’s experience and expertise in nucleic acid chemistry is outstanding and they're a great partner to have with the sgRNA technology.”

ReciBioPharm stated that Hongene’s novel technology for sgRNA synthesis will enable the CDMO to reduce impurities when compared with traditional production methods.

“In traditional sgRNA manufacturing, impurities are very challenging to control during synthesis, and also difficult to remove during purification,” the spokesperson said. “The ligation technology uses shorter oligonucleotides as raw materials, so there are fewer synthetic steps and opportunities for impurities to form during their synthesis. These shorter oligonucleotides are joined with ligase to make the full-length sgRNA with minimal formation of new impurities. However, some shorter oligonucleotide impurities are purged during that process. We can therefore achieve purities of 95% for sgRNA using Hongene’s process whereas for traditional synthesis, it's a huge challenge to routinely achieve even 80% purity with consistent batch-to-batch quality.”

A spokesperson for Hongene told BioProcess Insider “Through this collaboration, we can now provide an integrated suite of services, including this improved sgRNA synthesis technology, for gene-editing customers.”

The two companies are preparing to begin manufacturing for clients while exploring the needs and timeline expectations of their customer base. The ReciBioPharm representative said that “a typical gene-editing program might take anywhere from nine to 15 months from the time someone signs a contract to the time they get clinical material, depending on the program complexity.”

The Hongene spokesperson acknowledged that the companies are working through logistical challenges to ensure the best experience for customers. “ReciBioPharm and Hongene have a common customer base in gene editing and other spaces, such as mRNA and oligonucleotide therapeutics,” the spokesperson said. “There’s potential for us to collaborate in other areas of business in the future. Our priority though is to bring success for customers in the gene-editing field.”