Process Development Analytical Development

As a CDMO, we manufacture oligonucleotide and peptide APIs of high quality using advanced technologies. Please contact us for services ranging from small-scale synthesis for drug efficacy and toxicity studies in the drug discovery stage to contract research on process development and test development for pilot manufacturing, and GMP-compliant API manufacturing for clinical trials.

In process development, we propose an evaluation proposal based on consultations with our customers and create a robust manufacturing method.
This method can be transferred to us by the customer, built by us from scratch, or proposed by us following technology transfer from the customer.

In addition to scale-up and scale-down studies, we extract critical factors that affect the amount of impurities and confirm the control range using statistical analysis software. We support quality risk management with Quality of Design in mind.

We develop analytical methods for various testing items required for the quality control of oligonucleotide & peptide drugs, such as purity, quantitative determination methods, moisture, endotoxin, molecular weight confirmation, and sequence analysis, in a manner suitable for your development stage from exploration research to commercial stage.

We offer services for analytical method validation, specifications of raw materials and test methods, quality testing of APIs and intermediates, impurity evaluation, stability testing, etc., in a manner suitable for your development stage from explanatory research to clinical trials. Our expert team will develop and provide analytical methods for oligonucleotides and peptides using our comprehensive facilities.