CMC Research
Suzhou Olipharma provides customers with a globally advanced oligonucleotide drug technology platform and overall CDMO solutions, as well as comprehensive, highly customized and high-level services covering oligonucleotide drug process development, analytical method development and validation, stability study and drug registration. As a result, we can help partners to accelerate the whole process of products from preclinical preparation to commercial production, save valuable time and cost for them, and finally achieve the corporate vision of "Making nucleic acid drugs benefit the world".
1. Process development and validation
Having professional technicians, advanced instruments and sophisticated synthesis and purification processes, Suzhou Olipharma has a strong capability of process development and is committed to providing stable and scalable process routes/solutions with superior quality and professional services for customers.
● Abundant experience: Team members have been concentrating on the field of oligonucleotide drug development for more than a decade, thereby accumulating abundant experience in synthesis and preparation of oligonucleotides. The Company has completed the production of various types of oligonucleotides, having the scale-up production experience in successful development of oligonucleotide products from milligram to kilogram
● Professional talents: The Company gathers professional talents in the field of oligonucleotides. Key technicians all have particular experience in the analysis of key process control points and process impurity sources, and also in the production scale-up of oligonucleotide products.
● Process compliance: The Company completes the process development and generates the process reports in accordance with the requirements of the National Medical Products Administration and ICH Guideline, strongly supporting clinical application of innovative nucleic acid drugs.
2. Analytical method development and validation
The Company can develop the methods for different oligonucleotide products from the perspectives of product purity, related substances, moisture, elemental impurities, sodium salt, residual solvents, content, microbial limits and bacterial endotoxin, and carry out methodological validation of the developed analytical methods according to customer requirements, so as to make them meet the testing and quality control requirements of oligonucleotide drugs.
3. Stability study
