Drug Substance Manufacturing

Wide asset scale range

Nitto Avecia has the synthesis and downstream processing assets to support production of batches from a few mmols up to 1600 mmol. We have ISO8-qualified, HEPA-filtered manufacturing suites and multiple cGMP manufacturing trains. Our assets are distributed across our Milford and Cincinnati locations, allowing us to provide you with the best manufacturing options for your project.

Dependable supply chain

Vendor audits, multiple sources of key materials, and capable handling of customer supplied reagents are some of the essential components of Nitto Avecia’s reliable supply chain network. These elements work together with our internal storage and testing controls to ensure the quality and availability of raw materials for manufacture.

Late phase and commercial product experience

Nitto Avecia has been equipped to support the commercial launch of oligonucleotide products since 2005, and we currently manufacture commercial supplies of oligonucleotides. We have the expertise and resources to support the Process Performance Qualification (PPQ) phase of your project and the associated regulatory inspections.