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Manufacturing Services

Antisense Oligonucleotides (ASOs)

Moving the elements of life

ASO Manufacturing

What Are Antisense Oligonucleotides?

Antisense oligonucleotides (ASOs) are short, synthetic strands of nucleotides designed to specifically bind to RNA molecules, typically mRNA. By binding to their target RNA, ASOs can modulate gene expression, providing a highly targeted approach to treating genetic disorders and various diseases. This well-established technology represents a significant tool in the field of precision medicine, offering targeted therapeutic solutions for conditions that were previously considered untreatable.

Gapmers
Gapmers are antisense oligonucleotides that contain a central DNA gap flanked by chemically modified RNA nucleotides. They work by inducing RNA cleavage through RNase H recruitment, making them effective in gene silencing for therapeutic applications targeting mRNA​​.

How ASOs Work

Antisense oligonucleotides work by binding to complementary RNA sequences, thereby interfering with the normal processing or translation of the target RNA. This binding can lead to the degradation of the RNA molecule, block its translation into protein, or alter its splicing. The specific mechanism depends on the design and target of the ASO, allowing for precise and customizable interventions.

Key Applications


  1. Genetic Disorders: By targeting the underlying genetic mutations, ASOs can correct or mitigate the effects of these diseases at the molecular level. So far, ASOs have primarily been approved to treat genetically driven neurological disorders.
  2. Cancer Therapy: Targeting specific oncogenes or other cancer-related genes, providing a novel approach to cancer therapy. By silencing genes that drive cancer progression, ASOs can potentially halt tumor growth and enhance the effectiveness of existing treatments.
  3. Viral Infections: Targeting viral RNA to inhibit viral replication and reduce the viral load in infected individuals, offering a promising strategy against viruses such as HIV and hepatitis B.

Antisense oligonucleotide (ASO) therapies have already been approved for various conditions, particularly genetic disorders. Learn more about nucleic acid applications and approved therapies.

Customized Manufacturing and Analytical Excellence

BioSpring Services Overview

We are supporting our clients from early small-/mid-scale manufacturing of their drug development candidates to late-stage clinical and commercial manufacturing, including all related analytical activities.

Research_to_commercial_

Our Manufacturing Services At One Glance

Research & Discovery

  • Manufacturing for R&D, lead screening & lead optimization
  • Custom manufacturing solutions & chemistries
  • High-throughput manufacturing

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Preclinical

  • Early preclinical, mid-scale batch manufacturing
  • Regulatory tox batch manufacturing
  • Process development & scale-up

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Clinical & Commercial

  • Commercial manufacturing
    & process validation
  • cGMP manufacturing for
    clinical Phase I-III (ICH Q7)
  • Process transfer, optimization
    & scale-up

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Our Analytical Services At One Glance

Analytical Services

  • Release testing for drug substance & drug product
  • Stability studies for drug substance & drug product (ICH compliant)
  • Raw material method transfer, development & validation (for API & drug product)
  • Raw material analysis
  • In-house impurity marker synthesis
  • Analytical method transfer, development & validationn
  • Stress tests / forced degradation studies
  • Reference standard characterization
  • In-process control analysis

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Bioanalytical Services

  • Extraction of nucleic acids from various biofluid & tissues
  • Quantification by hELISA, LC, LC-MS, LC-MS/MS & qPCR in the lower ng/mL range
  • Metabolic stability, pharmacokinetics & identification of metabolites
  • Non-GMP & GMP analyses available
  • Method validation according to ICH M10

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Your Success Begins with us

Why Choose BioSpring?

Project Management and Regulatory Support

With your success as our priority, our dedicated project managers and subject matter experts provide strategic and technical support from your initial inquiry to product delivery and beyond. Our regulatory team offers comprehensive support, handling everything from technical writing and dossier maintenance to thorough reviews of submissions like IND, NDA, BLA, and DMF filings, ensuring all documentation meets regulatory standards. Count on us to be by your side throughout the entire project lifecycle, ensuring your goals are achieved every step of the way.

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Project Management
Your success begins with us

Why Choose BioSpring?

State-of-the-Art Facilities

Our FDA-inspected facilities are designed to optimize capacity utilization and ensure rapid turnaround with high-throughput capabilities, allowing us to support versatile batch requirements for programs targeting both ultrarare and more prevalent diseases. Equipped to manage every aspect of nucleic acid manufacturing and analysis—from small-scale preclinical batches to commercial-scale production—BioSpring brings nearly three decades of experience to ensure your nucleic acid programs are delivered on time and meet the highest quality standards.

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Facilities
Your success begins with us

Why Choose BioSpring?

Comprehensive Services

At BioSpring, we provide a full suite of manufacturing and analytical services to support your project from start to finish. Whether you’re in the early phases of your therapeutic nucleic acid program or looking to scale up production, we’ve got you covered.

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Comprehensive Services
Your success begins with us

Why Choose BioSpring?

Decades of Expertise

With almost 30 years of experience in oligonucleotide process chemistry, we have been at the forefront of nucleic acid technology, advancing the limits in nucleic acid manufacturing and analysis. Since achieving cGMP certification in 2007, we have continuously upheld the highest standards in quality and compliance. Our commitment to excellence and almost a decade of commercial experience helps you harness the full therapeutic potential of nucleic acid-based therapies​​.

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Experience
Your success begins with us

Why Choose BioSpring?

Flexible Timelines

We understand that timing is everything in drug development. That’s why our services are designed with flexibility in mind. From clinical trials to commercial production, we work closely with you to meet your goals efficiently and on schedule. No matter where you are in your development cycle, we ensure that our services align with your unique timeline​.

Flexible timelines

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Keep Exploring

Learn more about the nucleic acids we can manufacture for you:

CpG ODNs, guide RNAs, mRNAs, siRNAs, & more

Learn more about the manufacturing grades we offer for your nucleic acids: 

cGMP - Commercial / Clinical, Pre-GMP, Preclinical,
Research, Diagnostics