Manufacturing Services
Our expert team develops, formulates and manufactures therapeutic innovation throughout your product’s full lifecycle—from preclinical and early-phase toxicology studies to the market. We conduct early-phase process development and non-GMP process optimization for highly challenging liquid or lyophilized drug products, manufacture non-GMP drug products as reference material or for tox studies, perform R&D and GMP stability studies and release testing, provide tech transfer services and more.
Full Product Lifecycle Manufacturing Services
As a natural extension of Coriolis Pharma’s drug product development and analytical services, our non-GMP manufacturing services and our GMP manufacturing support will help you on your journey.
Toxicology Study and Reference Standards Manufacturing
Coriolis supports your need for non-GMP liquid and lyophilized drug product for preclinical toxicology studies and reference standard applications. Drug products manufactured by Coriolis to serve as reference standards are high quality and well characterized, serving as reliable benchmarks for analytical testing and quality control. Likewise, biopharmaceutical materials produced for tox studies are also high quality, well characterized and scalable to meet study needs.
Lead Lot Stability Material
For early- and late-phase stability studies, Coriolis manufactures non-GMP liquid and lyophilized lead lot stability material to study, monitor and document the stability of the drug product throughout its intended shelf life when stored and transported as designed.
Process Characterization & Development
Our team takes a phase-appropriate approach to biopharmaceutical drug product process development. While reproducibility is paramount and GMP considerations are kept front and center, processes become increasingly robust throughout development, derisking your path to a successful commercial product launch.
Manufacturing and Process Development Troubleshooting
Scalable and reproducible processes are required to manufacture high-quality drug products. However, reaching this state when designing and executing manufacturing processes for increasingly complex therapeutics is sometimes easier said than done. Coriolis Pharma’s team of experts has tackled hundreds of process development and manufacturing troubleshooting projects for a wide range of therapeutic modalities.
Stability Studies
Our expert team conducts stability studies throughout a drug product’s lifecycle, including early-phase stability studies to identify a drug product’s primary degradation pathways or later-phase stability studies on registration batches, transport studies, long-term accelerated studies or real-time studies. We’ll help you understand and optimize your biopharmaceutical product’s stability profile and meet all regular or critical product attribute specifications.
Release Testing
Coriolis Pharma’s GMP release testing services verify a drug product’s adherence to the designed target product profile (TPP), stability, safety, efficacy and compliance with all appropriate regulatory requirements.
Technology Transfer
Our expert team streamlines the tech transfer process whether you are beginning a new program or need support transferring a Coriolis-developed process to a larger-scale CDMO. We make the tech transfer process simple, seamless and consistent.
Comparability Studies
After a change of product, excipients, process or manufacturing site, Coriolis can perform comparability studies to verify the similarity of the new drug product and compliance with its safety, efficacy and quality attributes.
Pump Studies
Coriolis can perform comparability studies for different pump setups to verify the effect of pumping on your drug product.
Headspace and CCIT Studies
We provide oxygen and moist headspace analysis and container closure integrity testing (CCIT) according to EU GMP Annex 1.
Your Drug Product
Coriolis Pharma’s deep expertise across many biologic modalities, combined with input from world-leading external advisors, offers the knowledge and experience needed to solve even the most complex formulation and drug development challenges. We’ve worked with more than 930 compounds, including drug substances like live virus vaccines, viral vectors or cell therapies that require biosafety level 2.
Your Phase
Our expert team has the expertise and experience to guide your drug product development program from preclinical and early-phase development to the market.
Manufacturing Services Project Success Story
Successful Manufacturing Troubleshooting Solves Manufacturing Issues
The Challenge
A biopharmaceutical drug product for clinical trials showed elevated particles in several batches. Production was stopped, and Coriolis was contacted to investigate the issue.
Our Solution
After assessing several in-process samples and the final drug product using specialized particle characterization and identification techniques, we identified pump tubing as the source of particles. We discovered that changing the type of tubing resolved the issue.
The Coriolis Effect
In addition to a large portfolio of specialized analytical techniques, our experts have in-depth knowledge of individual production steps and potential problem points for drug product within biopharmaceutical production processes. This allows us to perform focused troubleshooting in short turnaround timelines.
Drug Product Manufacturing Services Resources
Publications
August 1, 2018
Publications
Can Controlled Ice Nucleation Improve Freeze-Drying of Highly-Concentrated Protein Formulations?
November 1, 2013
