Commercial Services
Our team of experts is committed to providing comprehensive services that address the challenges of commercial-scale production, ensuring your product maintains defined quality standards while remaining competitive and compliant.
Commercialization
Our Commercial Services
Our experts leverage their extensive experience and scientific acumen to ensure sustained product quality. Our commercial services include GMP release testing, drug product stability testing, manufacturing troubleshooting and more.
Drug Development Services for Commercial Phase
In addition to providing exceptional drug development services throughout the entire therapeutic lifecycle, we also offer lifecycle management reformulation services, supporting opportunities to extend the market value of your asset(s).
Analytical Services for Commercial Phase
As your drug product moves toward and beyond market approval, Coriolis Pharma’s analytical services provide the rigorous testing and validation needed for commercial success. We offer a wide array of validated methods and custom method development to meet regulatory requirements and ensure product quality, including reliable GMP release and stability testing.
Manufacturing Services for Commercial Phase
Even the most well-defined and optimized process can encounter challenges. Coriolis Pharma’s manufacturing troubleshooting services support your team in identifying and remediating anomalies in your manufacturing processes that impact product quality, production efficiency or compliance.
Commercial-Phase Project Success Story
Successful Troubleshooting Solves Manufacturing Issues
The Challenge
A biopharmaceutical drug product for clinical trials showed elevated particles in several batches. The production was stopped, and Coriolis was contacted to investigate the issue.
Our Solution
After assessing several in-process samples and final products using specialized particle characterization and identification techniques, we identified a pump tubing as the particle source. By changing the type of tubing, we resolved the issue.
The Coriolis Effect
In addition to a large portfolio of specialized analytical techniques, our project groups have in-depth knowledge about the criticality of individual production steps and potential stress situations for a drug product. This allows us to perform focused troubleshooting with little turnaround time.
Your Drug Product
Our experts enable preclinical success, accelerating and derisking drug development programs. We have extensive experience with biopharmaceutical drug products, including highly concentrated protein formulations and active pharmaceutical ingredients (APIs) like live virus vaccines and viral vectors that fall under biosafety level 2.
