Overview
BioSpring is a GMP oligonucleotide CDMO providing end-to-end manufacturing services for RNA therapeutics, from early discovery through commercial-scale production. The company specializes in solid-phase synthesis, analytical development, and cGMP-compliant manufacturing of antisense, siRNA, aptamers, and other oligonucleotide therapeutics. BioSpring supports pharmaceutical companies in scaling complex molecules while ensuring regulatory compliance with FDA, EMA, and ICH guidelines.
Frequently asked questions
- What oligonucleotide manufacturing services does BioSpring provide?
- BioSpring offers comprehensive CDMO services including custom oligonucleotide development, solid-phase synthesis, scale-up from discovery to multi-kilogram GMP campaigns, analytical method development, and commercial-scale manufacturing. The company supports the full lifecycle from early discovery through clinical development and commercial production of antisense, siRNA, aptamers, and sgRNA therapeutics.
- What regulatory standards and certifications does BioSpring maintain?
- BioSpring operates cGMP-compliant facilities and develops regulatory-ready CMC packages for IND, NDA, and BLA filings. The company meets global regulatory standards including FDA, EMA, ICH, NMPA, and PMDA requirements, with comprehensive quality systems, analytical validation, and stability programs aligned with international guidelines.
- What is BioSpring's manufacturing capacity and scale capabilities?
- BioSpring provides flexible manufacturing at multiple scales, from grams to kilograms of oligonucleotides per batch, supporting early-stage development through Phase II/III clinical supply and commercial production. The company leverages advanced downstream purification capabilities and multi-line GMP production systems designed for large-scale output.