Nitto Avecia Pharma Services: API To Clinic Within 4 Months

Nitto Avecia Pharma Services, Inc. has a focused vision. We envision each engagement with prospective or long-term clients as an opportunity to deliver innovative ideas that support their mission. Our corporate vision is “Creating Wonders,” and we take that to heart with each service we provide, priding ourselves in being fast and flexible and knowing full well that our clients require a partner to move in sync. As speed to clinic is crucial to our clients’ success, we offer a seamless package of CMC analytical development and testing as well as manufacturing services from early phase through commercialization.

How do I get to clinic within 4 months?

With a track record spanning 30 years, we have capabilities and expertise that differentiates us from our competitors. We have robust analytical testing and development platforms for therapeutic proteins and monoclonal antibodies fully integrated into our fill-finish operations. This gives us the ability to quickly move clients to the clinic within four months of API receipt. We are seeking partners with sound technical acumen to complement our technical transfer know-how. We have the equipment, the technical capability, and the customer-centric service model that delivers on time, every time.

Our mutual success is based on a client-centric approach and how much preparation has been done when we meet. Specifically — do you have a formulation? What is your understanding of the design space — the critical process parameter settings in a multidimensional model of space that each CPP can move within and still create the desired drug product with the desired critical to quality attributes? There are, of course, other things to consider such as excipients, material compatibilities, dosing, etc. Based on positive answers to these components, as well as getting your API, we can turn around your clinical batch within a four-month time frame.

What is Nitto Avecia’s flexibility in fill finish?

We focus on early-phase clinical fills. We can support a wide range of standard vial sizes and stopper configurations. As such, we are experts at small-volume manufacturing, mainly for Phase I-III, although we can handle commercial products, which usually consist of rare and orphan disease drugs that have a max batch size of 50L. We can fill-finish liquids, suspensions, liposomes, solutions and lyophilized products. We can handle up to a Safebridge 2 classification. We also work with DEA-scheduled products or animal products. We can also support high potency analytical testing but not manufacturing.

Why Nitto Avecia Pharma Services?

Our company is a wholly-owned subsidiary of Nitto Avecia, Inc., a leader in manufacturing and development services for DNA, RNA and other oligonucleotide-based therapeutics from milligram scale at pre-clinical stage to 1000kg + post commercial launch. We are further backed by Nitto Denko Corporation, an organization with more than 30,000 employees and 100 years strong. This corporate structure has given rise to our “One Avecia” single-solution-provider approach. From drug substance manufacture and test to drug product manufacturing and release, we are uniquely positioned to deliver end-to-end service all under one corporate entity. We offer the exact same network solution for you to provide you with seamless expertise during the initial journey from concept to commercialization.

by Ron Ortiz, Sr. Director of Operations Excellence