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.