Process Design & CMC
Engineering Drug Delivery to Unlock Therapeutic Potential
Process design and CMC strategy are foundational to translating therapeutic concepts, including their drug delivery systems, into clinical reality. We develop scalable, reproducible processes that maintain formulation integrity while controlling critical quality attributes impacting safety, efficacy, and biodistribution. By integrating formulation, manufacturing, and regulatory planning early, we mitigate scale-up risk, strengthen regulatory readiness, and streamline clinical advancement.
Turning Formulation Intent into Manufacturing Reality
Our integrated process development strategy establishes control of critical attributes from early design through scale-up, regulatory submission, and GMP tech transfer, ensuring reproducibility, product integrity, and confident clinical advancement of LNPs, PNPs, and polymeric microspheres.
Engineering Control of Critical Attributes
Control of Critical Quality Attributes and Critical Process Parameters ensures consistent performance, reproducibility, and regulatory alignment throughout development and scale-up.
Establish Process Design & Scale Up Strategy
Clinical process design and scale-up translate formulations from laboratory to manufacturing, preserving performance and controlling critical parameters for regulatory compliance.
Upstream Process Development
Development of mixing or emulsification, purification, and filtration processes ensures consistent particle formation, impurity removal, composition control, and scalable high-quality product recovery.
Downstream Process Development
Downstream processing optimization, including TFF process development, enhances impurity removal, buffer exchange, concentration control, and particle stability for scalable, reproducible manufacturing.
Tech Transfer
Tech transfer readiness ensures fully documented, reproducible processes aligned for seamless GMP manufacturing transfer, with ongoing optimization and troubleshooting support.
Engineering Control of Critical Attributes
Control of Critical Quality Attributes and Critical Process Parameters ensures consistent performance, reproducibility, and regulatory alignment throughout development and scale-up.
Establish Process Design & Scale Up Strategy
Clinical process design and scale-up translate formulations from laboratory to manufacturing, preserving performance and controlling critical parameters for regulatory compliance.
Upstream Process Development
Development of mixing or emulsification, purification, and filtration processes ensures consistent particle formation, impurity removal, composition control, and scalable high-quality product recovery.
Downstream Process Development
Downstream processing optimization, including TFF process development, enhances impurity removal, buffer exchange, concentration control, and particle stability for scalable, reproducible manufacturing.
Tech Transfer
Tech transfer readiness ensures fully documented, reproducible processes aligned for seamless GMP manufacturing transfer, with ongoing optimization and troubleshooting support.
Engineering Control of Critical Attributes
Control of Critical Quality Attributes and Critical Process Parameters ensures consistent performance, reproducibility, and regulatory alignment throughout development and scale-up.
Establish Process Design & Scale Up Strategy
Clinical process design and scale-up translate formulations from laboratory to manufacturing, preserving performance and controlling critical parameters for regulatory compliance.
Upstream Process Development
Development of mixing or emulsification, purification, and filtration processes ensures consistent particle formation, impurity removal, composition control, and scalable high-quality product recovery.
Downstream Process Development
Downstream processing optimization, including TFF process development, enhances impurity removal, buffer exchange, concentration control, and particle stability for scalable, reproducible manufacturing.
Tech Transfer
Tech transfer readiness ensures fully documented, reproducible processes aligned for seamless GMP manufacturing transfer, with ongoing optimization and troubleshooting support.
Core Drug Delivery Solutions
Phosphorex offers expertise in the three dominant particulate drug delivery platforms, tailoring them to address program-specific needs.
THE PHOSPHOREX DRUG DELIVERY ENGINE IN PRACTICE
Rapid Benchmarking Identifies High-Expression LNP and Enables Scale-Up
Problem
A client developing a gene-editing therapy needed to rapidly identify an LNP formulation capable of delivering optimal in vivo expression while remaining suitable for downstream scale-up. With multiple benchmark lipid systems available, selecting the right formulation early was critical to avoid delays and unnecessary development risk.
Solution
Phosphorex fabricated and evaluated six benchmark LNP formulations, optimizing formulation buffers for each system to align with the target product profile. Five optimized formulations were advanced to 1 mg batch-scale production to supply in vivo mouse efficacy studies, enabling direct comparison of expression performance under consistent conditions.
Outcome
The highest-performing formulation was identified based on in vivo expression data. The program immediately advanced to scale-up, with Phosphorex producing an 85 mg batch of the selected formulation to support a subsequent rodent study, thereby accelerating development timelines and reducing formulation uncertainty.
The Phosphorex Drug Delivery Engine
The Phosphorex Drug Delivery Engine leverages our expertise and core drug-delivery technologies to optimize therapeutic performance, minimize systemic risks for patients, and ensure a scalable, clinically relevant process design.
Formulation Optimization
Scalable, clinically relevant delivery systems
Analytical Expertise
Tech Transfer, Process Optimization & Troubleshooting
Process Design & CMC FAQs
Updates & Expertise
Ready to Engineer Particles for Precision Drug Delivery?
Partner with Phosphorex to transform your therapeutic vision into a precisely designed, clinically viable drug delivery solution.