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Manufacturing Services

CpG ODNs

Moving the elements of life

CpG Oligodeoxynucleotide Manufacturing

What are CpG ODNs?

CpG oligodeoxynucleotides (CpG ODNs) are synthetic short single-stranded DNA molecules that contain unmethylated CpG motifs. These sequences mimic bacterial DNA and are recognized by the immune system via Toll-like receptor 9 (TLR9). Upon activation, CpG ODNs stimulate immune responses, making them valuable for enhancing vaccines, cancer therapies, and autoimmune disease treatments​​.

How CpG ODNs work

CpG ODNs bind to TLR9, which is predominantly found in certain immune cells like B-cells and plasmacytoid dendritic cells. This interaction triggers a cascade of immune responses, including the production of cytokines like interferon-alpha and interleukin-10. These immune responses help enhance the body's ability to fight infections, tumors, or respond to vaccines​.

Key applications

  1. Vaccine Adjuvants: Enhancing the efficacy of vaccines by boosting antigen-specific immune responses.
  2. Cancer Therapy: Stimulating the immune system to recognize and attack tumor cells.
  3. Autoimmune Diseases: Modulating immune responses to potentially alleviate conditions like lupus.

Learn more about nucleic acid applications.

Off-the-shelf product

CpG 7909

CpG 7909, also known as ODN 2006, PF-3512676, or Agatolimod, is a synthetic oligodeoxynucleotide immunostimulant composed of unmethylated CpG motifs with the power to activate the immune system through Toll-like receptor 9 (TLR9) signaling. Originally developed for cancer treatment and as an adjuvant for vaccines, CpG 7909 has shown promising properties.

CpG 7909 is commonly used as an adjuvant in a clinical setting for the testing of novel immunotherapeutic approaches. This compound can stimulate human B-cell proliferation, enhance antigen-specific antibody production, and induce interferon-alpha production, interleukin-10 secretion, and natural killer cell activity. This comprehensive immunomodulation makes it a valuable candidate in immunotherapy.

At BioSpring, CpG 7909 is manufactured using an established, multi-kilogram manufacturing process, ensuring reliability, safety, and consistency. It is produced following GMP standards to meet regulatory requirements and ensure the safety and efficacy of the therapeutic or vaccine candidate.

A DMF is available to speed up your IND. Customer access is facilitated by an authorization letter.

Need more information on pricing and availability?

STAY TUNED! Off-the-shelf ODN 1018 available soon.

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

ASOs, 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