Formulation Optimization
Translating Promising Biology into Clinical Performance
Particularly when developing advanced therapeutics, bridging the gap between promising biology, encouraging preclinical in vitro data, and clinical reality is often not straightforward. However, well-designed drug delivery systems are the way to overcome potency limitations, immunogenicity risks, and poor biodistribution. The Phosphorex Drug Delivery Engine provides industry-leading formulation optimization capabilities and expertise to transition a therapeutic from concept to a clinically relevant drug product.
From Payload Screening to Optimized Drug Delivery Formulation
Formulation screening and optimization, a critical component of The Phosphorex Drug Delivery Engine, systematically evaluates payload-drug delivery formulation combinations and refines composition and process parameters to identify and optimize clinically viable, high-performing formulations.
Understand Formulation Objectives
Our team collaborates with your team to solidify formulation objectives and the Target Product Profile (TPP).
Explore Payload Candidates
We evaluate multiple custom cargos of interest using controlled LNP, polymeric nanoparticle, or microsphere formulations.
Evaluate Drug Delivery Formulation Candidates
Using a single cargo, we fabricate and screen iterative formulation conditions to down-select prototype LNP, polymeric nanoparticle, or microsphere formulations.
Evaluate Active Targeting
In nanoparticle applications, screen targeting ligands of interest, such as Fab, scFv, VHH nanobodies, peptides, and small molecules, by tethering them to the prototype LNP or PNP composition and tailoring the conjugation chemistry and conditions to achieve the target product profile.
Formulation Optimization
Formulation optimization refines composition, materials, and process parameters to achieve stability, biodistribution, efficacy, manufacturability, and critical quality control for clinical translation.
Understand Formulation Objectives
Our team collaborates with your team to solidify formulation objectives and the Target Product Profile (TPP).
Explore Payload Candidates
We evaluate multiple custom cargos of interest using controlled LNP, polymeric nanoparticle, or microsphere formulations.
Evaluate Drug Delivery Formulation Candidates
Using a single cargo, we fabricate and screen iterative formulation conditions to down-select prototype LNP, polymeric nanoparticle, or microsphere formulations.
Evaluate Active Targeting
In nanoparticle applications, screen targeting ligands of interest, such as Fab, scFv, VHH nanobodies, peptides, and small molecules, by tethering them to the prototype LNP or PNP composition and tailoring the conjugation chemistry and conditions to achieve the target product profile.
Formulation Optimization
Formulation optimization refines composition, materials, and process parameters to achieve stability, biodistribution, efficacy, manufacturability, and critical quality control for clinical translation.
Understand Formulation Objectives
Our team collaborates with your team to solidify formulation objectives and the Target Product Profile (TPP).
Explore Payload Candidates
We evaluate multiple custom cargos of interest using controlled LNP, polymeric nanoparticle, or microsphere formulations.
Evaluate Drug Delivery Formulation Candidates
Using a single cargo, we fabricate and screen iterative formulation conditions to down-select prototype LNP, polymeric nanoparticle, or microsphere formulations.
Evaluate Active Targeting
In nanoparticle applications, screen targeting ligands of interest, such as Fab, scFv, VHH nanobodies, peptides, and small molecules, by tethering them to the prototype LNP or PNP composition and tailoring the conjugation chemistry and conditions to achieve the target product profile.
Formulation Optimization
Formulation optimization refines composition, materials, and process parameters to achieve stability, biodistribution, efficacy, manufacturability, and critical quality control for clinical translation.
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
Elevating Gene Editing LNP Quality
Problem
A biopharma company developing a novel co-encapsulated gene-editing LNP system was dissatisfied with the batch quality produced by its incumbent supplier. Variability in particle attributes and cargo integrity raised concerns about suitability for downstream development and clinical translation, prompting the search for a new delivery partner.
Solution
Phosphorex delivered a high-quality LNP batch with a 77 nm mean particle size, PDI of 0.039, and 97% encapsulation efficiency following a freeze/thaw cycle at –80 °C. mRNA cargo integrity closely matched the theoretical 1:1 ratio. The success led to a repeat project and a third engagement to explore new formulations.
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.
Process Design & CMC
Robust process development and IND-enabling CMC strategy
Analytical Expertise
Tech Transfer, Process Optimization & Troubleshooting
Drug Delivery Formulation Optimization 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.