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.
Services We Can Provide:
1. Raw material selection service.
The selection, exchange period and quality stability of raw materials and excipients are the keys to ensure the quality stability and project cycle of oligonucleotide. Creative Biolabs has established a complete quality assurance management system for raw materials and auxiliary materials to ensure the important links of total quality system management.
We provide but are not limited to:
- Strict selection of key materials. The nucleoside phosphorous amide monomer and solid phase support are selected from high quality level of international well-known suppliers.
- Perfect internal control system and quality standard of raw materials. Each batch of raw materials are applied after strict quality control.
- Stable supply chain guarantee system. There are many qualified suppliers of raw materials and auxiliary materials to ensure their stable and continuous supply.
- Customer material inspection ability. Creative Biolabs has the ability to inspect the special nucleoside or modified phosphorous amide monomer provided by customers. Creative Biolabs can complete the customized production of the supplied materials from customers.
2. Production process development service.
Creative Biolabs has been committed to the development of stable amplification, low cost and green oligonucleoic acid production process over the years. Creative Biolabs accumulats rich experience in nucleic acid drug preparation process, and successfully helped customers to develop a number of important processes.
3. Chemical modification and coupling process development service.
Creative Biolabs has experience in the development of various chemical modification and coupling processes for oligonucleotide, helping customers successfully customize tens of thousands of chemical modification products which cover hundreds of chemical modification types.
4. Quality control methods development service.
Creative Biolabs has established a world-class quality control system for the production process of single-stranded and double-stranded oligonucleotide drugs of CPG, siRNA and chemical modification. Creative Biolabs helps customers form a perfect technical standard for quality control.
5. Production process validation service.
Production process transfer and verification service can be carried out by means of project management. After the establishment of the project, the project leader and project team members of Creative Biolabs can be determined to clearly determine the transfer and verification schedule. Creative Biolabs will manage the whole project process in real time, and the project leader will hold regular meetings and coordinate the work.
6. Preparation process development service.
Thank you for choosing our service of oligonucleotide process development. 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.