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Manufacturing Services

Conjugated Oligonucleotides

Moving the elements of life

Conjugated Oligonucleotide Manufacturing

Manufacturing, conjugation support and analytical services for oligonucleotide conjugates across therapeutic modalities

What are oligonucleotide conjugates?

Oligonucleotide conjugates are oligonucleotides that are chemically linked to another molecule to support a specific therapeutic or technical objective. Depending on the program, the conjugated component may help improve delivery, target a specific tissue or cell type, influence pharmacokinetic properties, support cellular uptake, or enable additional functionality.

Conjugation strategies are used across different oligonucleotide modalities, including siRNAs, ASOs, aptamers, and other nucleic acid-based constructs. Common examples include GalNAc-conjugated siRNAs or ASOs, lipid-conjugated oligonucleotides, peptide- or protein-oligonucleotide conjugates, antibody-oligonucleotide conjugates and PEG-ligated aptamers.

Because each conjugated oligonucleotide combines oligonucleotide synthesis with additional conjugation, purification and analytical requirements, successful development depends on a well-aligned strategy for modification site, linker chemistry, conjugation route, analytical characterization and phase-appropriate manufacturing.

 Capabilities 

Conjugate modalities we support

GalNAc | Antibodies / AOCs | Peptides / POCs| Proteins | Lipids | PEG | Other conjugates
(Bio-)conjugation
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BioSpring can support the development of conjugation and purification strategies aligned with the oligonucleotide modality, target molecule, intended application, and clinical phase. Our integrated approach combines oligonucleotide manufacturing expertise with analytical method development, release and stability testing, and GMP-compliant documentation where applicable. Depending on project requirements, conjugation steps can be performed in-house or coordinated in collaboration with the client’s preferred partner.

  • In-house (bio)conjugation and purification options available to support programs
  • Optimization of bioconjugation strategies aligned with your modality, target tissue, and clinical phase
  • In-house execution or collaboration with your preferred partner, based on your development strategy
  • Integrated analytical method development and validation for conjugated molecules and intermediates

Modification Options & Linker Chemistries

We offer a wide range of options for introducing conjugates, including post-synthetic 5’ modifications and modified amidites; internal modifications via modified amidites, and; 3’ modifications through pre-loaded solid supports including UnyLinker and modified amidites. In addition, we offer a variety of linker chemistry options suitable for most applications.

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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.

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Our Manufacturing Services At One Glance

Research & Discovery

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

Learn more about our manufacturing services for research & discovery.

Preclinical

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

Learn more about our preclinical manufacturing services.

Clinical & Commercial

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

Learn more about our clinical & commercial manufacturing services.

Our Analytical Services For Conjugated Oligonucleotides At One Glance

Conjugated oligonucleotides can require dedicated analytical strategies for the oligonucleotide, conjugation partner, intermediates and final conjugated molecule. BioSpring supports analytical method development, method transfer and validation, release testing, stability studies, impurity analysis, reference standard characterization and in-process control analysis.

We have established methods to analyze:

  • Antibodies
  • Peptides & proteins
  • Antibody- & protein/peptide-oligonucleotide conjugates
  • Lipid-conjugated oligonucleotides

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

Learn more about our analytical services for nucleic acids.

Bioanalytical Services

  • Extraction of conjugated oligonucleotides 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

Learn more about our nucleic acid bioanalytical services.

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.

Learn more about our project management and our regulatory support.

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 oligonucleotide and mRNA 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.

Learn more about our facilities.

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 oligonucleotide/mRNA program or looking to scale up production, we’ve got you covered.

Learn more on our manufacturing and analytical services.

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 oligonucleotide- and mRNA-based therapies​​.

Learn more about our history.

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

Learn more about our solutions

Keep Exploring

Explore the nucleic acids we manufacture

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