Analytical Expertise
Reliable Data for Confident Decisions, Quality Products, Regulatory Success
Partnering with Phosphorex unlocks a deep bench of experts, instrumentation, and laboratory systems designed to support your program and drug product. By combining advanced chemical analysis and physical characterization capabilities with method development, we deliver accurate and precise results. From complex molecular characterization to routine quality control testing, our state-of-the-art laboratories support you from early-phase development to clinical readiness.
Integrated Analytical Strategy from Concept to Clinical Readiness
Analytical excellence underpins every stage of successful drug delivery development. We integrate early-phase characterization, stability understanding, and method qualification into a cohesive analytical program. By aligning formulation insight with process understanding and regulatory expectations, our team generates decision-enabling data that de-risks development and accelerates clinical advancement.
Early-Phase Analytical Development
Early-phase analytical strategy sets the trajectory for successful drug delivery development. Our scientists focus on proof-of-concept characterization to define the physicochemical properties that govern performance, safety, and manufacturability. By aligning early analytics with scale-up and regulatory expectations, we reduce development risk and prevent costly reformulation later.
Early-phase analytical focus includes:
- Particle size and distribution analysis
- Surface charge (zeta potential)
- Cargo content and encapsulation efficiency measurement
- Targeting ligand content and encapsulation efficiency measurement
- in vitro release profiling
- Cargo integrity and stability assessment
Stability-Indicating Method Development & Storage Stability Studies
Stability is fundamental to ensuring the safety, efficacy, and regulatory readiness of advanced drug delivery systems. We develop stability-indicating methods that detect changes in particle and cargo integrity over time. Our strategies incorporate ICH guidelines for stability testing and analytical method validation and are designed to support IND-enabling development. By integrating formulation, process, and analytical insights, we generate data that supports confident storage and shelf-life determination for regulatory submissions.
Stability method development & storage stability approach includes:
- Development of stability-indicating analytical methods capable of distinguishing intact product from degradation-related impurities
- ICH-aligned storage stability studies across relevant temperature conditions
- Monitoring of particle size, PDI, surface charge, and encapsulation efficiency over time
- Cargo integrity analysis for nucleic acids, peptides, and proteins (e.g., aggregation, oxidation, hydrolysis)
- in vitro release assessment during stability studies
Analytical Method Qualification & Regulatory Submission Support
Reliable analytical data is the foundation of regulatory confidence. Phosphorex designs and qualifies analytical methods that demonstrate accuracy, precision, specificity, linearity, and robustness in alignment with ICH guidelines for method validation. Our approach ensures methods are fit-for-purpose at each development stage while building toward IND and later-phase requirements. By integrating analytics with formulation and process knowledge, we generate defensible data packages that support smooth regulatory review.
Our method qualification and regulatory support includes:
- Phase-appropriate analytical method development and qualification
- Assessment of accuracy, precision, specificity, linearity, range, and robustness
- CQA determination aligned with formulation and process understanding
- Generation of high-quality data packages to support IND submissions
- CMC documentation support, including analytical sections for regulatory filings
- Comparability assessments following process or scale changes
Lead Formulation Advancement
Selecting a lead formulation requires more than strong early data; it demands analytical clarity and product understanding that predicts clinical and manufacturing performance. By generating comparative, decision-enabling data that link physicochemical attributes to biological outcomes and scalability considerations, we advance the most promising candidates with confidence. By integrating formulation, process, and analytics, we help ensure the chosen lead is built for clinical success.
Our lead advancement support includes:
- Comparative characterization of formulation candidates to support data-driven selection
- Correlation of particle attributes like particle size, polydispersity index (PDI), and surface charge or ligand content with in vitro and in vivo performance
- Encapsulation efficiency and cargo integrity assessment across candidate formulations
- Stability screening under relevant stress and storage conditions
- Evaluation of sterile filtration feasibility and manufacturability considerations
- Identification of CQAs critical to later-phase scale-up and regulatory readiness
- Data package development to support internal governance and IND-enabling progression
Analytical Methods Developed & Optimized
Phosphorex develops and optimizes a comprehensive set of analytical methods to guide nanoparticle and microsphere development.
Nanoparticles
- Particle size distribution (PDI)
- Zeta potential
- Cargo concentration
- Encapsulation efficiency
- Nucleic acid cargo integrity (CE/HPLC)
- Lipid quantitation (HPLC-CAD)
- Ligand Content Analysis (HPLC)
- Osmolality
- pH
- Residual moisture
- Endotoxin
- Residual solvent*
Microspheres
- Particle size distribution
- Drug loading
- Encapsulation efficiency
- in vitro release
- Syringability/injectability
- Deliverable dose
- Residual moisture
- Residual solvent*
- Optical microscopy*
*This service is outsourced to a trusted partner.
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, clinical process design.
Formulation Optimization
Scalable, clinically relevant delivery systems
Process Design & CMC
Tech Transfer, Process Optimization & Troubleshooting
Analytical Methods 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.