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From RUO to GMP

siRNA Manufacturing for Clinical Readiness

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From Research to GMP

Scalable Manufacturing for siRNA Therapeutics

As you prepare for your first clinical milestones, BioSpring provides phase-appropriate manufacturing, process development, and analytical support to rapidly scale your small interfering RNA (siRNA) program from research to GMP supply for first-in-human clinical trials.

The research to GMP Challenge

Scaling siRNA Therapeutics from Research to the Clinic

Moving siRNA programs into early clinical development presents unique challenges. Key considerations at this stage include: 

  • Scaling up manufacturing processes
  • Developing and validating analytical methods to meet regulatory expectations
  • Establishing appropriate GMP documentation such as batch records
  • Adressing increasing regulatory requirements - even in Phase I

With decades of experience, BioSpring is the partner that helps you navigate these challenges with confidence.

What We Deliver

Phase-Appropriate Solutions, Designed for First-In-Human Sucess and Beyond

With three decades of oligonucleotide manufacturing and analytical expertise, BioSpring advances your siRNA program through every clinical phase with:

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Optimized Process Development

Scalable, reproducible processes from lab-scale to GMP supply, leveraging platform technologies to save development time and reduce costs.

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Development & Validation of Analytical Methods

Purity- and stability-indicating analytical methods for oligonucleotide drug substance and drug product.

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Clinical-Grade GMP Manufacturing

Flexible batch sized tailored to your needs across all clinical phases, from grams to tens of kilograms.

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Regulatory & Documentation Support

Full traceability, GMP-compliant batch records, QC data packages, and scientific writing expertise.

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Dedicated Development Teams

Cross-departmental coordination and project chemists ensuring timely execution and seamless scale-up.

Built to Scale

Purpose-Built Facilities to Support Every Clinical Phase

  • GMP-certified since 2007
  • FDA-inspected GMP facilities
  • Manufacturing and process technologies backed by over 20 years of experience
  • Capacity to immediately onboard your program
  • Nine in-house laboratories
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Your Research to GMP Pathway

The Journey from Research-Grade to GMP Production

  1. Initial Sequence Review & Manufacturability Assessment - manufacturing of multiple lead candidates and evaluation of the oligonucleotide sequences to provide early insights into their manufacturability, defining a clear course for process setup and scale-up.
  2. Process Adaption - small scale test run to confirm purity and yield expectations. Optionally, the process can be further adapted and optimized on client request.
  3. Analytical Development - establishment of phase-appropriate analytical methods.
  4. Pre-GMP Engineering / Tox BatchRisk - confirmatory scale-up batch prior to GMP manufacturing, where required, commonly used for regulatory tox studies.
  5. GMP Production (ICH Q7) - compliant batch manufacture with in-process controls, full QC testing, and documentation.

This structured pathway ensures a transition into Phase I and beyond, reducing unnecessary scale-up risks from the very first GMP batch.

Hundreds of oligonucleotide programs successfully supported

Let Us Help Bring Your siRNA Program to the Clinic - And Beyond

  • Dedicated to synthetic nucleic acids since 1997 - specialized in siRNA, ASOs, aptamers, guide RNAs, mRNA, and more! 
  • Trusted by leading pharma and biotech companies worldwide
  • End-to-end capabilities - from early development through commercial GMP supply
  • Dedicated technical teams with extensive siRNA expertise

What comes next

Let's Build Your Clinical Manufacturing Pathway - Together

Whether you’re entering Phase I or still defining your development roadmap, BioSpring can help you bridge the research to GMP transition with confidence.

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