Nucleic Acid Drug CDMO & CMO Service
CDMO is a key link between drug development and commercial marketing of nucleic acid drug. The upstream of CDMO is the CRO link of preclinical development and the downstream is the continuous CMO production link after the drug is marketed. The nucleic acid drug CDMO & CMO technology platform of Creative Biolabs has the advantages of human resources, professional knowledge and core technologies, which can help pharmaceutical companies save costs, control risks and improve R&D efficiency.
Services We Can Provide：
1. Oligonucleotide Production and Manufacturing Process Development
Oligonucleotide production and manufacturing process development is an important part of nucleic acid drug development. Creative Biolabs provides end-to-end oligonucleotides production and manufacturing services. As a leading contract custom nucleic acid drug research and development productionpartners, Creative Biolabs has leading technology advantages, talent advantage and platform advantage. With high quality system of key raw materials, process, transfer and verification, and strict management for drug production, Creative Biolabs can assist customers to realize efficient and economic production targets.
We provide but are not limited to:
- Raw material selection service
- Production process development service
- Chemical modification and coupling process development service
- Quality control methods development service
- Production process validation service
- Preparation process development service
- IND declaration service
2. Method Validation and Stability Analysis of Nucleic Acid Drug
Creative Biolabs provides a full range of analysis and testing services from nucleic acid product development to commercialization, utilizing a variety of in vitro method, in vivo method, molecular biology, analytical chemistry and precision instrumental analysis methods to guide the design of testing programs and quality standards recognized by regulatory agencies worldwide.
Services We Can Provide:
- The development, certification and validation of analytical methodology.
- Validation of analysis methods.
- Drug stability analysis service.
- Study schedule service.
- Packaging material analysis and verification.
3. Preparation and Aseptic Filling or Lyophilization Service
Creative Biolabs is building aseptic preparation production workshops for filling line, including automatic liquid preparation, automatic aseptic filling and packaging of nucleic acid pharmaceutical products, which meet FDA of the United States, EMA of the European Union, CNDA of China and the specification requirements of other countries and regions, such as Japan and South Korea. Creative Biolabs uses high quality and proven cyrin bottles, rubber plugs and aluminium caps from the world's leading packaging suppliers. Creative Biolabs provides customers with a one-stop service for the full range of nucleic acid drugs, including drug discovery, clinical research and commercial production.
Services We Can Provide:
- Preparation service.
- Aseptic Filling service.
- Aseptic lyophilization service.
Creative Biolabs is a professional biotechnology service platform that provides nucleic acid drug CDMO & CMO. Thank you for choosing our service. If you have any questions, please contact our staff, we will answer and serve you immediately.
*For Research Use Only. Not for use in diagnostic procedures.