Frequently Asked Questions

BioSpring provides end-to-end manufacturing and analytical solutions for nucleic acids, such as therapeutic oligonucleotides (e.g., ASOs and siRNAs), guide RNAs, and mRNA:
•    cGMP manufacturing for clinical Phase I-III (ICH Q7)
•    Commercial manufacturing & process validation
•    Preclinical, mid-scale batch manufacturing
•    Scale-up to support regulatory tox studies, up to multi-kg batch sizes
•    Manufacturing for R&D, lead screening, & lead optimization
•    High-throughput manufacturing
•    Process development
•    Scale-up, process transfer, & optimization
•    Analytical method development, transfer, & validation (API & DP)
•    Release testing & stability studies (API & DP)
•    Bioanalytical services

Additional services:
•    Manufacturing of diagnostic oligonucleotides (ISO 13485)
•    Off-the-shelf cGMP CpG 7909 (Agatolimod) available & ODN 1018 (coming soon)
•    Regulatory support including IND-filing

BioSpring is known for unmatched expertise and know-how in nucleic acid chemistry. Founded in 1997, we are one of the most experienced CDMOs wholly focused on nucleic acid  manufacturing and analysis. We are committed to advancing nucleic acid technology, producing high-quality solutions that have supported hundreds of our clients' clinical studies and several commercial programs worldwide. 

BioSpring's portfolio of manufacturing experience is extensive. We produce a wide range of nucleic acids including custom siRNAs, ASOs, Gapmers, ssDNAs, mRNAs, aptamers, long RNAs, tRNAs, and more. We are also the leading guide RNA manufacturer for in vivo and ex vivo applications. 

We excel in manufacturing nucleic acids of any complexity at any scale. BioSpring offers all modifications and our expertise extends to manufacturing highly modified, complex molecules involving customized chemistries and starting materials. 

 

Yes, BioSpring has been cGMP-certified (ICH Q7) for Therapeutic Oligonucleotide Manufacturing and Quality Control since 2007. 

Yes, BioSpring underwent its first FDA inspection in 2016, and has been regularly inspected since, successfully.

Yes, since 2012, we are ISO 9001-certified and ISO 13485-certified for the manufacture of diagnostic oligonucleotides.

BioSpring typically manufactures oligonucleotides using solid-phase synthesis technology. We also offer mRNA by in vitro transcription (IVT). 

Yes, we are a global partner for manufacturing commercial therapeutic oligonucleotide APIs. We support with all stages of commercial readiness including process validation and post-launch activities. In addition, we offer drug substance and drug product release testing and stability studies for commercial oligonucleotide products. 

Yes, we manufacture nucleic acids for commercial diagnostic applications such as forensics, microbial and viral testing, and HLA-typing, in addition to early-stage research and development projects. We offer manufacturing compliant with ISO 13485, ISO 9001 and according to FDA 21 CFR Part 820. See our diagnostic services page.

We offer nucleic acids at all scales, from micrograms to multiple hundred kilograms (annually), supporting clients from the early discovery stage through clinical and commercial programs. Our GMP manufacturing scales range from small batch sizes for ultrarare disease and cell and gene therapy programs, to commercial-scale batch sizes for common disease programs, and everything in between. We ensure flexibility and scalability to meet diverse manufacturing needs. 

Yes, we provide extensive regulatory filing support, including technical writing and maintenance of dossier sections and review of dossier submissions​. 

As a worldwide partner for nucleic acid services, we have clients based in all corners of the world. Our dispatch department ships nucleic acids internationally on a daily basis, providing tracking and support through delivery. For cGMP material, we ship through trusted courier partners at the required temperature with full monitoring and tracking, ensuring compliance with global regulatory standards​.