Rockland Launches Novel Analytical Tools to Assess Drug Delivery: Revolutionizing Oligonucleotide Therapeutic Development

OCTOBER 17, 2023

The first and only panel of specialty reagents designed to detect PS modifications independent of sequence, format, or location, streamlining candidate triage for unparalleled cost and time savings in non-clinical/pre-clinical discovery assessment of oligonucleotide drug candidates, clinical trials for immunogenicity studies, and other applications.

LIMERICK, Pa .— Rockland is a leading USA-based life science company, developing analytical tools that assist in the collection of pharmacodynamic, pharmacokinetic, and toxicology data critical for satisfying regulatory requirements for biological drugs, cell and gene therapies, and RNA therapeutic drugs (e.g., ASO, siRNA, mRNA). To date, Rockland has successfully generated reagents against many diverse nucleic acid chemical structures and modifications, including conventional oligonucleotides, DNA-RNA hybrids, single- and double-stranded RNA, and more.

Presently, there is a need to replace in situ hybridization (ISH) assays and other assays that are not immunoassay-based for monitoring absorption, distribution, metabolism, excretion and toxicology (ADMET). Traditionally, ISH-type assays have been the mainstay method of detecting and localizing oligonucleotides in cells and tissues for nucleic acid therapy development. However, with the inability of ISH to bind and detect short oligo therapeutic drug sequences, and because it requires unique probes to each oligonucleotide candidate, the process for probe development and candidate triage continues to require significant time and budget—until now.

Introducing the ModDetect™ Phosphorothioate (PS) Panel (patent pending), an immunoassay-based alternative that provides robust detection of oligonucleotide therapeutic drug delivery and analysis, facilitating the collection of ADMET analytical data for regulatory approval.

The ModDetect™ PS panel is the first and only ready-to-use panel of specialty reagents that can detect phosphorothioate modifications independent of nucleic acid composition, structure, strandedness, configuration, or platform. The universal nature and unique specificity and sensitivity of these reagents eliminates the need for unique probe design, development, and use, and accelerates candidate triage for a cost-effective, low-risk solution that can save 9-12 months in drug development. The applications for the ModDetect™ PS Panel are endless—to determine biodistribution, intracellular localization, anti-drug antibody binding or immunogenicity, protein binding in serum and tissue lysates—just to name a few.

The ModDetect™ PS Panel consists of five different reagents reactive specifically to the phosphorothioate chemical modification commonly designed into oligonucleotide drugs and can be used in various immunoassays, such as ELISA, immunofluorescence (IF), and immunohistochemistry (IHC). The panel is also being made available in both unconjugated or biotin-conjugated formats.

ModDetect™ is a growing suite of analytical tools generated against different types of nucleic acid chemical modifications. Currently in development are 2’-O-Methoxyethyl (MOE) and 2’-O-Methyl (OMe) Panels. Learn more and stay up to date with the latest ModDetect™ offerings by visiting ModDetect™ Panels. Rockland also provides custom antibody generation against various oligonucleotide targets and modifications, including both modified backbones and nucleosides. In addition to custom anti-oligonucleotide antibodies, Rockland offers conjugation services, producing high-quality, oligo-protein conjugates as a complete solutions provider to the oligo therapeutics industry.

About Rockland:

Established in 1962, Rockland is a global biotechnology company developing leading-edge analytical tools for biologics, and cell, gene, and RNA therapy development. We specialize in fully customized, fit-for-purpose, anti-oligonucleotide antibodies as a contract research service or by way of immediately available specialty reagents. With USA-based R&D, manufacturing, and raw material facilities, Rockland can fully develop, optimize, and validate each analytical tool, ensuring supply chain security and protection of client confidentiality and intellectual property.

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