A Quarter Century of Experience
For a quarter century, BioSpring has successfully delivered innovative, high-quality nucleic acid manufacturing and analytics solutions spanning the complete lifecycle: from discovery to commercial use.
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.
As an expert in the field of nucleic acids, we serve pharmaceutical, biotech clients and academia worldwide.
Commercial Manufacturing & Process Validation Services
BioSpring is your experienced and reliable partner for commercial therapeutic nucleic acid manufacturing.
Our facilities are FDA-inspected for commercial manufacture and analytics of oligonucleotide APIs and cGMP-certified by the German authorities. We are officially registered as an API manufacturer with the FDA, EMA and PMDA. Dedicated commercial manufacturing suites and multiple-hundred kg of annual manufacturing capacity allow for a seamless and flexible onboarding of your commercial program.
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.
Our services to support your market authorization:
- Process characterization
- Range-finding studies (e.g. DOE, OFAT)
- Critical parameter determination (CPP & nCPP)
- PPQ batch manufacture
- Cleaning validation
- Risk assessments
- Raw material & analytical method validation
- Continous process verification
- Life cycle management
cGMP & Pre-Clinical Manufacturing
For more than two decades, BioSpring has been manufacturing nucleic acids for pre-clinical and clinical programs. APIs manufactured by BioSpring have been used in over 150 clinical studies worldwide. We have been cGMP-certified since 2007 and we are FDA-inspected for commercial manufacture, supporting our clients beyond clinical manufacturing to assist them in attaining market authorization.
We support our clients from early small-/mid-scale manufacture of their drug development candidates to late-stage clinical and commercial manufacture, including all related analytical activities.
Our state-of-the-art facilities and application of cutting-edge technologies for nucleic acid synthesis and downstream processing ensure reproducible product quality and patient safety. Multiple clean rooms provide maximum flexibility for continuous and parallel manufacturing of cGMP-grade nucleic acicds.
Service Overview
- 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 120 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
- Gram 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
We are committed to producing nucleic acids of the highest quality for research & development. Our manufacturing platform is based on more than a quarter century of experience and hundreds of thousands of successfully synthesized nucleic acids. A dedicated nucleic acid specialist provides clients with support from their first inquiries to product delivery and beyond.
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
- A broad range of synthesis chemistries and modifications
- A 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
sgRNA for Genome & Base Editing
With more than half a decade of experience and over 75 cGMP and pre-clinical large-scale campaigns manufactured to date, we are the industry's go-to partner for therapeutic guide RNAs.
We manufacture all guide RNAs using chemical solid-phase synthesis ensuring highest quality and reproducibility.
We offer guide RNA manufacture at all scales and lengths, for:
- R&D/discovery to late-stage/commercial
- Eliminating the need of a second supplier and optimizing the drug development life cycle by being your single source for manufacturing
We are experienced in manufacturing all classes of guide RNAs, including guide RNAs for base editing, with the most extensive experience in manufacturing single-guide RNAs (sgRNAs) 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 field.
Furthermore, we are leading with its 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.
The industry’s leading partner for cGMP guide RNAs
- 20 years experience in manufacturing modified RNAs
- 5 years experience in guide RNA (sgRNA) cGMP manufacturing – double-digit gram batch sizes
- 75 cGMP & pre-clinical large-scale guide RNA (sgRNA) manufacturing campaigns
- cGMP processes established for > 100 guide RNA candidates
- cGMP-certified for 14 years; FDA-inspected
- Process validation & commercial readiness support for guide RNAs
- Continuous capacity increase & development of technologies for guide RNA manufacture
Nucleic Acids for Diagnostics
We are a well-established nucleic acids manufacturer 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)
- Consistently 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