Oligonucleotides in Generic API Management

Our vast experience in commercialization of complex generics including fermentation, peptides, and inorganic complexes makes us a perfect choice as a partnership for Oligonucleotide development. We have multiple products in our pipeline and portfolio, and offer efficiency and scale to suit your business requirements.

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Our Process

We offer an optimized robust automated synthesis process, and our downstream process capabilities include a variety of purification techniques, from Lyophilization to UF/DF and more. We use the DOE approach (Design of Experiments) a branch of applied statistics known for effective planning, analyzing and interpreting tests in a controlled way. Our computational tools allow for scale-up/scale-down modeling that applies to all process stages, and we offer deep engineering support on scale-up.

Process Assets
Process Assets

What are Oligonucleotides?

An Oligonucleotide is a short sequence of RNA or DNA spirals. They are considered to be big-small molecules and fall under the small molecule regulation, at the range of 5-15K Da. They can contain up to ~100 nucleotides, but typically contain ~18-42 mer. Common types of oligonucleotide include:

  • ASO – Single stranded DNA/RNA, target mRNA binding, splicing.
  • siRNA – Double stranded RNA, target RNA termination.
  • Micro RNA – Double stranded RNA, marking target mRNA blocking its translation to protein.

Our Solution

Our solution is characterized by its full process control, from RM through to the final product.

Our impurity profile is characterized by IP-LC-MS, using either extraction or deconvolution method. We approach sequencing by applying high-resolution LC-MS, and can offer residual and trace analysis, counter ion analysis, and spectral P-NMR.

We use a stability and degradation pathway study, as well as general physico-chemical properties characterization. In terms of scale, we have a lab scale of up to 200g annually, and we are mid-scale for GMP material, with 1-2kg annual production, with a tech transfer lead time of 18 months. Talk to us about higher manufacturing scale per your capacity demands.

Our Advantage

We have vast experience in the commercialization of complex generics, including fermentation, peptides, inorganic complexes and more.

We offer tailor-made development for Oligonucleotide development, with end-to-end global RA support.

We put a strong focus on efficiency in R&D and in the commercial phases, and can curate a collaboration model that works for your business needs.

When you’re ready, we have the ability to scale and support a wide portfolio, as an industry leader in generic API development and production. In terms of Oligonucleotide development, we already have multiple products in our pipeline and portfolio, making us best-placed to enter a partnership for your business growth.

Interested in Oligonucleotids, or learning more about our work on molecular development?

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