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From lab to life

GMP Oligonucleotide Manufacturing

Manufacturing and analytical support for therapeutic oligonucleotide programs, from early development to commercial supply.

Discuss your project

Support across development and supply

BioSpring combines oligonucleotide manufacturing with analytical services and regulatory support. The scope is tailored to the development stage and requirements of each program, with a focus on quality, scale and CMC readiness.

Specializing in synthetic nucleic acids since 1997, BioSpring supports a broad range of therapeutic oligonucleotide modalities.

Built on trust. Enabling your therapeutic breakthroughs.

Commercial record

10 commercial oligonucleotide
programs supported

Quality systems

cGMP-certified since 2007
FDA-inspected since 2016

No lead time

Immediate onboarding of your therapeutic program

Integrated support

Manufacturing, analytics and
regulatory expertise

Capacity

Multi-kg capacity with ongoing expansion 

One partner

Preclinical development through commercial supply

Specialized CDMO support

Why GMP oligonucleotide manufacturing requires a specialized partner

Therapeutic oligonucleotides place specific demands on manufacturing, analytics and quality systems. As programs move toward GMP manufacturing, early process choices can influence scale-up, impurity control, analytical comparability and the long-term ability to supply clinical or commercial material.

BioSpring supports this transition with teams that work specifically on therapeutic oligonucleotides. Manufacturing, process and analytical development, QC and project management are coordinated to help clients establish a practical path from early-stage material to GMP supply.

What BioSpring manufactures

Therapeutic oligonucleotides across modalities and development stages

BioSpring supports a broad range of therapeutic oligonucleotide modalities. Manufacturing strategies are adapted to the molecule’s sequence, chemistry, scale, quality grade and development stage.

Looking for the full category overview? Explore nucleic acid manufacturing →

Development path

From early development to GMP supply

A program may begin with limited material requirements and still need to be designed with later scalability in mind. BioSpring supports clients across research-grade, preclinical-grade, pre-GMP ("GMP-like") and GMP manufacturing, allowing programs to progress through development stages with increasing quality and documentation requirements.

The objective is not to overbuild early work. It is to identify the right level of manufacturing and analytical control for the current stage while keeping later GMP and commercial requirements in view.

 

Integrated manufacturing and analytics

Analytical control built into the manufacturing path

For oligonucleotide therapeutics, analytical strategy is essential to high-quality manufacturing. Method development, impurity characterization, release testing and stability studies all influence how confidently a molecule can progress through development.
BioSpring integrates analytical support into manufacturing workflows, helping clients align process development, scale-up, release testing and documentation in one coordinated project environment.

Looking for the full analytical overview? Explore Analytical Services →

Late-stage and commercial readiness

Built on proven late-stage and commercial support

BioSpring supports 10 commercial oligonucleotide programs and has more than 10 years of commercial manufacturing experience. Commercial products manufactured by BioSpring are marketed across major global markets. These signals are highly relevant for clients evaluating risk, long-term supply and regulatory readiness.

For late-stage and commercial programs, BioSpring supports process characterization, validation activities, comparability studies, commercial analytical testing and regulatory documentation.

Commercial support can include

✓ Documentation for regulatory milestones and lifecycle activities

Infrastructure and scale

Capacity, quality systems and expansion aligned with program demand

As therapeutic oligonucleotide programs mature, manufacturing requirements often increase sharply. BioSpring supports multi-kg batch sizes for high-volume indications and continues to expand manufacturing and analytical capacity for future program needs.

For clients, this supports more reliable supply planning, fewer handovers and a clear pathway from clinical demand to commercial supply.

Manufacturing infrastructure includes

✓ Platform technologies supporting rapid scale-up
✓ Ongoing expansion toward metric-ton capacity

Regulatory and CMC support

Documentation and technical support for clinical and commercial milestones

Manufacturing decisions become part of the regulatory story. BioSpring supports clients with documentation and technical input for clinical filings, market authorization and lifecycle activities. 

Clients benefit from BioSpring's in-depth experience with international regulatory agencies like FDA, EMA, PMDA, and ANVISA. 

 



 

Regulatory and CMC support may include

✓ IND, IMPD, NDA, BLA and DMF-related support, as applicable
✓ Authoring and review of regulatory documents
✓ Support for authority requests
✓ Risk assessments and post-approval change management

Ready for what's next? 

How we start
1
You share the basics
Sequence and modality, desired manufacturing grade and target scale
2
We evaluate your requirements
Our team reviews the project requirements and curates a project plan
3
You receive a proposal and timeline
Scope, deliverables and costs
Icon_BioSpring_30 years experience

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Accelerate your success with us:

Reduce CMC risk, keep timelines predictable, and progress confidently to submission and launch.

Learn more about our solutions

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Explore our manufacturing grades

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CommercialClinicalPre-GMPPreclinicalResearchDiagnostics

Explore the nucleic acids we manufacture

View all nucleic acids
AOCsASOsCpG ODNsguide RNAsmRNAssiRNAsXNA& more