Case Study | Why The Right Partner is Key to Successful Drug Innovation

Author: Justin Divan, North America Custom API Product Sales

Jul 2021

At Pfizer CentreOne, we are proud to collaborate with pioneering companies in navigating the drug development journey to bring their innovations to market and transform the lives of patients. 

Biotech company, Enterin, is one such pioneer, whose mission is to become the first company in the world to develop a drug that repairs the dysfunctional gut-brain axis in patients with neurodegenerative disease.

Enterin is reshaping the understanding of the link between dysfunction of the enteric nervous system (ENS) of the gut and the early onset and chronic progression of neurodegenerative diseases such as Parkinson’s Disease. Its partnership with Pfizer CentreOne is an example of what a trusting and open collaboration can accomplish.

Working with Pfizer CentreOne

Putting the life of your company and several years of work into the hands of a CDMO partner is a big decision. Biotech companies like Enterin need a trusted partner with the expertise and experience to deliver.

Enterin completed the first human clinical trials for ENT-01 which demonstrated that oral administration of its treatment has restored function of the nervous system of the gastrointestinal tract in Parkinson’s patients.[i] 

Enterin had specific requirements that made it even more important to choose the right CDMO. A key ingredient in ENT-01 is squalamine, which comes from an unusual class of steroidal molecules that are very complex and challenging to handle. Pfizer’s specialists’ knowledge of this kind of chemistry meant that it was the ideal partner for the job.

Dr. Michael Zasloff, Enterin’s CSO and founder, said, “The Pfizer CentreOne team is an extraordinarily creative and well-integrated group of people who know what they are talking about. To accompany this expertise, it was important to have access to the right facilities. Pfizer’s Kalamazoo site is the finest manufacturer of steroidal, cholesterol-based molecules in the world. Since squalamine’s synthesis originates from steroidal chemistry, the Pfizer CentreOne Kalamazoo site and local team were a perfect fit.”

Tackling challenges

Pfizer CentreOne supported Enterin at every step in the synthesis of ENT-01; from providing the initial starting intermediate through refinement of the steps, leading to the API. Whenever challenges appeared with the manufacture of the API, the team came up with creative solutions that showcased its scientific talent.

For example, the process that was originally used to create the polyamine tailpiece of the molecule, a vital component, was highly explosive. A new method was needed that was safe and suitable for scale-up.

The team at Pfizer CentreOne looked at the whole synthesis and completely revised how to create and attach the tailpiece, optimizing safety and successfully scaling up production. As a result of this innovative approach, Pfizer CentreOne already has enough of the material stored on site for when ENT-01 enters Phase III of development.

More than just manufacturing

The team at Pfizer CentreOne brought value to Enterin’s business through its expertise and creativity. Many CDMOs can replicate an existing process but discovering a novel approach and collaborating with partners is where the team delivered.

Speaking about the future of the relationship, Dr. Zasloff commented: “As ENT-01 is shown to be safe and effective, we will need to scale up production quickly. We are trusting Pfizer CentreOne to manufacture hundreds of metric tons from the small quantities we have made thus far.

This scale up is essential to reach patients around the world. Ultimately, Pfizer CentreOne will be responsible for the commercial manufacturing [launch] of the new drug, which we hope will represent a major new addition to treatment of neurological diseases.”

To find out more about the development services offered by Pfizer CentreOne, contact us today.

 

[i]  Targeting neurons in the gastrointestinal tract to treat Parkinson's disease, Clinical Parkinsonism & Related Disorders, International Association of Parkinsonism and Related Disorders (IAPRD)