A Quarter Century of Experience
With over a quarter century of experience and know-how, BioSpring delivers innovative, high-quality oligonucleotide manufacturing and analytical solutions spanning the entire drug development process, from discovery to commercial use. From as small as nmol production for R&D programs to hundreds of kilograms for clinical programs and beyond, BioSpring accommodates all scales to meet you at your program's stage.
We are driven to move your oligonucleotide therapy to clinical and commercial readiness.
BioSpring is GMP-certified for the manufacture and analysis of therapeutic nucleic acids since 2007 and FDA-inspected, making us one of the most tenured CDMOs in the field. Rely on our commercial experience and analytical expertise to support you through all regulatory filings, upholding the strictest compliance so you can hit your targets.
From small-scale production for R&D to hundreds of kilograms for therapeutic use, from industry-leading analytical expertise to cutting-edge processes: BioSpring covers all your needs for nucleic acid manufacturing.
BioSpring is FDA-inspected and has been cGMP-certified for the manufacture and analysis of therapeutic nucleic acids since 2007, making us one of the most tenured CDMOs in the field. Rely on our commercial experience and analytical expertise to support you through all regulatory filings, upholding the strictest compliance so you can hit your targets.
Commercial Manufacturing & Process Validation Services
Our manufacturing facilities in Germany are FDA-inspected for both the commercial manufacture and analytics of oligonucleotide APIs and GMP-certified by German authorities.
We are officially registered as an API manufacturer with the FDA, EMA and PMDA. Our multiple dedicated commercial manufacturing suites and hundreds of kgs of annual manufacturing capacity allow for seamless and flexible onboarding of your commercial program. Recently, we announced metric ton capacities available in 2025.
BioSpring has been validating nucleic acid drug substance manufacturing processes since 2016. We have successfully completed multiple process validation campaigns (multi-kg batch sizes) for industry-leading clients and are actively manufacturing commercial batches for market supply.
Supporting your therapy's market authorization:
- Life cycle management
- Risk assessments
- Critical parameter determination (CPP & nCPP)
- Process characterization
- Range-finding studies (e.g. DOE, OFAT)
- PPQ batch manufacture
- Cleaning validation
- Raw material & analytical method validation
- Continous process verification
cGMP Manufacturing
GMP-certified since 2007 and FDA-inspected for the commercial manufacture of oligonucleotides, BioSpring’s APIs have by now been used in over 250 clinical studies worldwide. We support our clients from early small-/mid-scale manufacture of their therapeutic oligonucleotides to late-stage clinical and commercial manufacture, including all related analytical activities. Our single-source services are designed to accelerate your therapies past market approval and onto commercial realization.
Our state-of-the-art facilities with cutting-edge technologies for nucleic acid synthesis and downstream processing are formulated with reproducible product quality and patient safety in mind. Multiple clean rooms provide maximum flexibility for continuous and parallel manufacturing of cGMP-grade nucleic acids.
Overview of Services
- cGMP manufacturing for clinical Phase I – III
- Process validation and commercial manufacture
- Manufacturing of nucleic acids for R&D, as well as lead candidate screening and development
- Process development – more than 140 successful programs each year
- Scale-up, scale-down and process transfer
- Pre-clinical non-GMP batch manufacture
- Regulatory tox batch manufacture
- Generation of reference standards
Facilities and Capacities
- Annual manufacturing capacity: multiple-hundred kg
- nmol/µg to multiple-kg pre-clinical, cGMP, and commercial manufacture
- 8 separate high-class cGMP manufacturing trains, plus dedicated areas for synthesis and lyophilization; additional clinical and commercial manufacturing trains in planning
- Next-generation OligoProcess and OP400 synthesizer platforms
- Dedicated commercial manufacturing trains
- Dedicated pre-clinical manufacturing areas
- cGMP compliant QC-laboratories for in-process and release testing
We are the industry’s go-to partner for complex oligonucleotides, including highly-modified, conjugated and long oligonucleotides. Our cGMP manufacturing experience includes the following oligonucleotide classes, modifications and conjugates:
Nucleic acids for R&D
BioSpring is committed to providing the highest quality, comparable and scalable manufacturing processes, across all grades. With over a hundred thousand successfully synthesized nucleic acids in the past decade alone, BioSpring’s manufacturing platform is designed for the quality manufacture of your unique sequences.
Our preclinical and diagnostic manufacturing teams specialize in small-scale material starting from nmol/μg up to mid-scale manufacture of several grams. Should your program require additional material, our interdivisional cooperation allows for seamless upscaling up to kg scales. Beyond synthesis, we offer expert analytical services and project support from inquiry through delivery.
Several prerequisites contribute to our product quality
- High-quality raw materials from selected suppliers
- Optimized and controlled manufacturing processes executed by highly qualified, trained professionals
- Continuous monitoring of in-process controls and final products by our Quality Control Department, which utilizes state-of-the-art technologies to analyze oligonucleotides
Expertise, quality, reliability and flexibility
- Manufacturing at all scales
- Broad range of synthesis chemistries and modifications
- Broad spectrum of post-synthetic conjugation techniques (e.g., terminal GalNAc conjugates & PEGylation)
- Established synthesis platforms for long and complex nucleic acids (e.g., gRNAs for CRISPR/Cas9)
- Customized processes
- Manufacturing strategies specifically designed for in vivo applications
guide RNA Manufacturing
With more than half a decade of experience and over 125 cGMP and preclinical large-scale campaigns manufactured to date, we are the industry's leading partner for therapeutic guide RNAs. We offer the highest quality guide RNA for your genome editing therapy to accelerate your path to clinic.
BioSpring is the most experienced guide RNA manufacturer for therapeutic CRISPR/Cas programs in the industry. We constantly invest in continued capacity increase, expansion of services, and development of new manufacturing technologies in the therapeutic guide RNA manufacture space. By the end of 2023, we plan to triple our guide RNA manufacturing capacity to support even more therapeutic programs.
We are leading efforts to develop cutting-edge analytical techniques to address the analytical challenges associated with guide RNAs. We support our clients with analytical method development and validation from early-stage to commercial, as well as offer IND/IMPD and NDA/MAA support.
The industry’s leading partner for cGMP guide RNAs
- 21 years experience in manufacturing modified RNAs
- 6 years experience in guide RNA (sgRNA) cGMP manufacturing
- >125 cGMP & preclinical large-scale guide RNA (sgRNA) manufacturing campaigns
- cGMP manufacturing processes and analytical methods established for > 175 guide RNAs
- FDA-inspected and GMP-certified
- Analytical method development and validation for guide RNAs - early stage to commercial
- Extensive commercial readiness support
guide RNA Manufacturing & Analytics
- Platform approach to reduce onboarding time for therapeutic programs
- Established small-scale manufacturing processes (e.g., for lead screening) in preparation for therapeutic applications
- Continous capacity increase & development of new technologies for guide RNA manufacturing and analysis
Nucleic Acids for Diagnostics
BioSpring’s portfolio extends to oligonucleotide manufacturing for commercial diagnostic applications such as forensics, HLA-typing, microbial & viral testing and early-stage research & development projects in the field of diagnostics. We offer manufacturing compliant with ISO 13485, ISO 9001 and according to FDA 21 CFR part 820.
Our scope of services includes:
- ISO 13485 certified Quality System (QS) regulation
- cGMP diagnostics (manufacturing according to FDA 21 CFR part 820)
- Consistent high quality
- Full traceability of raw materials and process steps
- Qualified supply chain
- A broad range of analytical methods
- A broad spectrum of nucleic acids modifications
- Manufacturing in a controlled environment
- Qualified cleaning procedures
- Proven processes to avoid human DNA contamination and cross-contamination
- Established solutions for complex forensic applications