Polymeric Nanoparticles
Engineered for Precision, Stability, and Scalable Performance
Polymeric nanoparticles (PNPs) offer a powerful alternative for delivering nucleic acids, peptides, proteins, and even small molecules with enhanced stability, controlled release, and targeted performance. The Phosphorex team designs biodegradable polymer-based nanoparticles that protect fragile payloads, extend circulation time, and enable tunable biodistribution. By integrating formulation expertise, scalable process development, and CMC strategy, we transform complex polymeric systems into clinically viable, manufacturable drug delivery solutions.
A Structured Path from Concept to Optimized PNP Formulation
Our PNP formulation screening and optimization services offer a methodical approach to systematically evaluating payload-PNP combinations and refining composition and process parameters to identify and optimize clinically viable, high-performing formulations.
Understand Formulation Objectives
Our team collaborates with your team to solidify PNP formulation objectives and your Target Product Profile (TPP).
Evaluate Drug Delivery Formulation Candidates
Using a single controlled cargo, we fabricate and screen iterative formulation conditions to down-select prototype PNP formulations.
Explore Payload Candidates
Explore multiple API cargos to screen and optimize the drug substance candidate using a prototype PNP formulation.
Evaluate Active Targeting
Screen targeting ligands of interest, such as Fab, scFv, VHH nanobodies, peptides, and small molecules, by tethering them to the prototype PNP composition and tailoring the conjugation chemistry and conditions to achieve the target product profile.
Formulation Optimization
Formulation optimization systematically refines PNP composition, materials, and process parameters to achieve desired stability, biodistribution, efficacy, manufacturability, and control of critical quality attributes for clinical translation.
Understand Formulation Objectives
Our team collaborates with your team to solidify PNP formulation objectives and your Target Product Profile (TPP).
Evaluate Drug Delivery Formulation Candidates
Using a single controlled cargo, we fabricate and screen iterative formulation conditions to down-select prototype PNP formulations.
Explore Payload Candidates
Explore multiple API cargos to screen and optimize the drug substance candidate using a prototype PNP formulation.
Evaluate Active Targeting
Screen targeting ligands of interest, such as Fab, scFv, VHH nanobodies, peptides, and small molecules, by tethering them to the prototype PNP composition and tailoring the conjugation chemistry and conditions to achieve the target product profile.
Formulation Optimization
Formulation optimization systematically refines PNP composition, materials, and process parameters to achieve desired stability, biodistribution, efficacy, manufacturability, and control of critical quality attributes for clinical translation.
Understand Formulation Objectives
Our team collaborates with your team to solidify PNP formulation objectives and your Target Product Profile (TPP).
Evaluate Drug Delivery Formulation Candidates
Using a single controlled cargo, we fabricate and screen iterative formulation conditions to down-select prototype PNP formulations.
Explore Payload Candidates
Explore multiple API cargos to screen and optimize the drug substance candidate using a prototype PNP formulation.
Evaluate Active Targeting
Screen targeting ligands of interest, such as Fab, scFv, VHH nanobodies, peptides, and small molecules, by tethering them to the prototype PNP composition and tailoring the conjugation chemistry and conditions to achieve the target product profile.
Formulation Optimization
Formulation optimization systematically refines PNP composition, materials, and process parameters to achieve desired stability, biodistribution, efficacy, manufacturability, and control of critical quality attributes for clinical translation.
The Phosphorex Drug Delivery Engine for PNPs
Translating PNP-based therapeutics from early biological promise to clinical reality requires coordinated formulation refinement, scalable process design, CMC alignment, analytical depth, and structured tech transfer. The Phosphorex Drug Delivery Engine integrates these disciplines to convert advanced polymeric nanoparticle systems into reproducible, manufacturing-ready therapies positioned for regulatory and clinical success.
Formulation Optimization
We design precise, scalable PNP formulations systematically evaluating payload-drug delivery formulation combinations and refining composition and process parameters to identify and optimize clinically viable, high-performing formulations.
Process Design & CMC
Analytical Expertise
Tech Transfer, Process Optimization & Troubleshooting
Why Phosphorex for PNPs?
20+ Years of Drug Delivery Leadership
Two decades of nanoparticle development experience translating complex therapeutics into clinically viable products.
Advanced Polymer Chemistry Insight
Expertise in poly(lactic-co-glycolic acid) (PLGA), polylactic acid (PLA), polycaprolactone (PCL), polyethylene glycol (PEG)-modified polymers, poly(beta-amino esters) (PBAEs), and novel cationic polymer systems for nucleic acid delivery.
Targeting & Conjugation Capabilities
Proven ability to engineer ligand-, peptide-, and mAb-conjugated PNPs for precise tissue and cellular targeting.
Integrated Formulation, Process & CMC Strategy
We design PNP systems with scalability, CQAs, and regulatory readiness built in from the outset.
Early Manufacturability Risk Identification
We proactively identify scalability and filterability risks before lead nomination, preventing costly redevelopment later.
Collaborative & Flexible Support
Collaboration drives agile iteration, rapid realignment, and seamless progression from formulation screening through IND-enabling scale-up and clinical manufacturing.
20+ Years of Drug Delivery Leadership
Integrated Formulation, Process & CMC Strategy
Advanced Polymer Chemistry Insight
Early Manufacturability Risk Identification
Targeting & Conjugation Capabilities
Collaborative & Flexible Support
THE PHOSPHOREX DRUG DELIVERY ENGINE IN PRACTICE
Protein-Loaded Polymeric Nanoparticles Advanced to Phase II for Autoimmune Disease
Problem
A biopharma partner required a targeted nanoparticle delivery system capable of safely and reproducibly delivering a protein antigen for an autoimmune indication. The program needed to progress beyond early feasibility to support IND-enabling studies and clinical manufacturing, while maintaining control over particle attributes and targeting performance at scale.
Solution
Phosphorex developed polymeric nanoparticles encapsulating the protein antigen and applied proprietary surface-engineering approaches to enhance targeting. The formulation and manufacturing process were scaled to greater than 100-gram batches, enabling production of GLP toxicology and IND-enabling materials. Phosphorex also designed a robust tech transfer strategy to support GMP manufacturing.
Outcome
The process was successfully transferred to a GMP facility, and clinical batches were manufactured to support Phase I and Phase II clinical studies, advancing the program toward clinical validation.
Polymeric Nanoparticles 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.