寡核苷酸生产的综合解决方案
我们的目标是通过创新帮助客户实现高质量、大规模和低成本的生产。
A Comprehensive Solution Provider
Our platform provides a comprehensive solution for oligonucleotide API manufacturing, from preclinical to commercial stages. We have leading capabilities in analytical development, manufacturing, and quality control throughout the entire development process.
Process Development
Our expertise in development and scaling encompasses a wide range of therapeutic oligonucleotide modifications, such as ASO, siRNA, Aptamer, Oligo conjugates, PMO, and PPMO molecules. We are continuously researching new technologies to enhance quality and decrease costs.
Analytical development
We collaborate with customers throughout the drug development process, method development and transfer, validation, and ICH stability studies to assist in CMC documentation for regulatory filings. We have a wide range of analytical instruments for analyzing oligonucleotides, including raw materials, intermediates, adjuvants, and APIs.
Drug Substance Manufacturing
We have the world-leading capacity for oligo synthesis and downstream processing, supporting API production of batches ranging from a few mmols up to 1800 mmol, at small to commercial-scale.
Quality Control
Our QC lab is equipped with advanced equipment to ensure the highest quality control. Our team tests raw materials, intermediates, crude active pharmaceutical ingredients (APIs), and final drug products.