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With your commercial future in mind

siRNA GMP Manufacturing

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Moving the elements of life

Supporting siRNA Programs Across Every Clinical Phase

Wherever you are in the clinical phases, BioSpring helps you scale your small interfering RNA (siRNA) programs confidently towards your future launch, with commercial-scale capacities and experienced teams that will enable smooth progression through all regulatory milestones.

With BioSpring at your side

From Clinical Supply to Commercial Readiness

At this stage, success depends on many critical factors that pave the way toward market authorization. Your program needs to scale reliably, withstand regulatory scrutiny, and be prepared for eventual market approval.

What's at stake:

  • Delays in tech transfer between CDMOs
  • Gaps in supply chain continuity
  • Reproducibility challenges at larger scales 
  • Revalidating analytical mathods too late
  • Lack of commercial-scale infrastructure
  • Fragmented regulatory and CMC documentation

You need a partner that prepares you not just for the next clinical phase but for long-term commercial success.

What We Offer

Phase-Appropriate Services That Scale Toward Launch

BioSpring supports GMP programs in clinical development and beyond with: 

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Clinical and Commercial GMP Manufacturing

Phase I-III supply under full GMP - leveraging commercial-ready infrastructure and commercial batch sizes

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Process Validation Services

Drawing on platform processes to accelerate GMP readiness and support commercial manufacturing

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Comprehensive Analytical Services

Development and validation of stability- and purity-indicating methods for oligonucleotide drug substance and product, supporting release analysis and stability studies

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Tech Transfer

Late-stage/commercial process and analytical method transfer, process optimization and scale-up, plus comparability studies to support regulatory submissions

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Regulatory Support

BioSpring's regulatory experts preparing compliant CMC documentation and supporting submissions to global authorities

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Commercial-Quality Systems

Proven track record and regularly audited by top 10 pharma

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Global Supply Chain Integration

We ship APIs to our clients everywhere in the world

Built to Scale

Facilities, Technologies & Experience

  • GMP-certified since 2007
  • FDA-inspected GMP facilities
  • ISO Class 7 certified cleanrooms 
  • Batch sizes from grams to tens of kilograms
  • In-house release testing & stability studies for drug substance & drug product
  • Commercial programs supported across US, EU, UK, Japan, Brazil, Saudi Arabia, China & more
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Even if you're not there yet

Set Up For Regulatory Submissions

We guide your program from first submissions to commercial approval with comprehensive regulatory and CMC support: 

  • Regulatory Submissions - preparation for Scientific Advice Meetings and review of global filings (IND, IMDP, NDA, MAA, J-NDA, BLA)
  • Validation Packages - complete documentation for analytical and process validation, submission-ready in line with ICH requirements
  • CMC & Quality Documentation - authoring of quality-related dossier sections (e.g. Module 3)
  • Risk Assessments - in-depth evaluations including nitrosamines and extractables & leachables (E&L)
  • Lifecycle Management - regulatory support for post-approval variations and ongoing compliance

We ensure your program meets global regulatory expectations.

Growing With Your Program

A Long-Term CDMO Relationship

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Dedicated cross funktional project teams

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Transparent communication & governance

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Full-service approach

Our full-service approach covers process development, GMP manufacturing, quality control, release testing, stability studies & more. 

We have supported clients from preclinical development all the way through to successful commercial launches - including 9 commercial programs supported to date. Let's plan for your future launch together! 

What comes next

Turning Clinical Progress Into Patient Access

BioSpring is ready to support your siRNA therapeutic program at every stage, from your next GMP batch to your first commercial launch. 

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