GMP Oligonucleotide Manufacturing Services
As more candidates entering preclinical and clinical development stages in the pharmaceutical industry, demands for GMP-quality oligonucleotides (oligos) have soared. Creative Biolabs has designed and built clinical API manufacturing facilities and factories in accordance with the specifications of the United States and the European Union, enabling us to provide customized and flexible cGMP API manufacturing services to meet your research and production needs from R&D to clinical research, and support your nucleic acid drug development.
Our GMP Services:
Flexible Production
Creative Biolabs has introduced the automated solid-phase synthesizer of oligonucleotide and established the world-class large-scale production line of oligonucleotide API. Using our unique production line, we can complete the production of oligonucleotide products for clinical use according to specific requirements, and support the phase I-II clinical research trials of new nucleic acid drugs. Creative Biolabs has successfully produced clinical Phase I-II oligonucleotide products for multinational customers. We can provide research-grade, product design verification and validation, or GMP-compliant oligonucleotides, assisting you from research to clinical phase I and II. The synthesis of each oligodeoxynucleotide undergoes strict quality control.
Rigorous Analysis Process
According to customers' requirements for different oligonucleotide products, Creative Biolabs can develop analysis methods of product purity, related substances, moisture, elemental impurities, sodium salts, residual solvents, content, microbial limit and bacterial endotoxin. Creative Biolabs performs methodological validation of the developed analytical methods to ensure that they truly meet nucleotide and drug detection and quality control requirements. We can transfer the methods to customers for further optimization and validation according to various specifications.
Quality And Risk Management
Creative Biolabs uses quality management tools combined with the nucleic acid drug manufacturing process to help customers establish a complete whole-process quality management system. At the same time, we use a risk management system to help customers control the risks of clinical oligonucleotide drug development processes.
Purification:
- Identified by MS, Sequencing
- Purified by UPLC / HPLC, Bioburden, Endotoxin level
Certifications:
- ISO 13485:2003 & ISO 9001:2008 certified
- Meet the requirements of GMP, ICQ7 and Part 11
Advantages:
- Highest standards production
- Cost-effective
- Rapid turnaround times
- Research-grade, pre-clinical-grade, GMP-grade oligos
- A broad range of chemistries and modifications.
- Gram-scale to kg-scale
Our GMP Oligonucleotide Manufacturing Services workflow
Creative Biolabs is the world's leading supplier of nucleic drug products and services. We have a leading nucleic acid synthesis, purification and analysis platform and professional talents to provide high-quality and reliable cGMP-level and non-cGMP-level oligonucleotide products. Our professional team is experienced in large-scale DNA/RNA synthesis and various chemical modifications, providing strong support throughout the production process for global partners.
Thank you for choosing our GMP oligonucleotide Manufacturing Services. If you have any questions, please contact us. W will respond immediately.
*For Research Use Only. Not for use in diagnostic procedures.