With research becoming highly-specialized, many companies are turning to CROs with particular skill-sets – especially in complex chemistry. For us at Neuland, companies tend to be looking for method development for complex molecules, a complete Analytical Validation Package, impurity synthesis & characterization, genotoxic impurity assessment and method development, specialized studies and more.
From Phase II Process Development – Through Clinical Trials & NDA Registration – to Manufacturing.
The process – for us – doesn’t stop when the development ends. Over the course of our 7+ year relationship with a U.S.-based pharmaceutical firm with multi-billion dollar global revenues, we’ve helped usher a product from Phase II process development through clinical trial and NDA registration into manufacturing.
This global market leader approached us with a complex API that had an equally-complex synthesis process. The firm had no in-house expertise to develop it, since the product had initially been licensed from abroad – and needed a reliable partner to advance the project to market. It was also the company’s first true NCE API, which is what brought them to us.
Specific NCE API Expertise Combined With Scale-Up Experience Makes the Difference.
Our proven expertise in process chemistry and successful scale up dovetailed perfectly with their clinical and commercial needs. Most importantly, we had expertise in the specific class of compounds that their NCE belonged to.
During the project, we:
- Took a medicinal chemistry process with almost 15 steps of synthesis and a host of industrially-unfriendly chemicals and reduced it to 8 commercially scalable steps.
- Created novel process intellectual property, which has been filed (and – in keeping with our policy of not competing with our clients – is assigned to the client).
From the Clinic to the Pharmacy.
In 2008, the product passed the CMC documentation process for the NDA filing and a successful Pre-Approval FDA inspection. Today, Neuland Labs is the only commercial supplier of an API with a demand of up to 500 kg a year – and growing.
Taking a Candidate Commercial Requires Planning and Experience.
At Neuland, we believe that the process of bringing a drug to market is a series of highly-interdependent (and reliant) steps that build upon each other. That’s why it’s so important to understand not only what happened upstream, but also what needs to happen downstream.
What steps of the research, development & commercialization process most frequently require your company to turn to contract research or manufacturing?