Polymorphism affects drug stability/bioavailability; LNPs' internal morphology (e.g., HⅡ phase) boosts RNA release efficiency. Creative Biolabs' service controls solid/liquid crystalline structures for consistent LNP performance.
It uses advanced solid-state analysis and proprietary LNP design to define API/excipient solid-state structures, de-risks therapeutic candidates, and ensures consistent, high-performing products from discovery onward.
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To provide a complete picture of your product's structural state, we analyze several core indicators using a suite of advanced, orthogonal detection methods.
| Crystallinity | The proportion of crystalline components (e.g., phospholipids, cholesterol) in LNPs relative to total lipids. It directly affects membrane rigidity, permeability, and drug encapsulation stability. |
| Crystal Form Type | Specific crystal structures in lipids or drug-loaded LNPs (e.g., gel phase, liquid crystal phase of phospholipids). Differences in physicochemical properties of crystal forms lead to varied LNP functions. |
| Crystal Form Transition Temperature | The temperature at which lipids undergo crystal form changes (e.g., gel phase → liquid crystal phase) during heating/cooling. It correlates with the LNP phase transition temperature (PTT) and affects drug release triggering conditions. |
| Crystal Form Distribution Uniformity | The consistency of lipid crystal forms across LNP populations. Uneven distribution causes batch-to-batch differences in drug loading and release performance, affecting formulation reproducibility. |
Our service follows a rigorous, multi-stage process suitable for visualization as a clear project flowchart, ensuring comprehensive and actionable results for your therapeutic candidate.
Review existing data and define analytical goals. Select suitable techniques based on sample type (API or LNP).
Receive samples, conduct specialized preparation. Perform initial screening for potential polymorphism.
Collect high-resolution data via multiple orthogonal techniques to elucidate all phase structures.
Develop quantitative methods to measure polymorph ratio. Conduct accelerated stability testing on preferred forms.
Analyze structural data's correlation with functional performance. Provide formulation and manufacturing control recommendations.
The typical timeframe for this service ranges from 6 to 12 weeks, depending on the complexity of the molecular structure, the number of polymorphic forms requiring investigation, and the need for advanced LNP structural imaging.
As a biology expert driving cutting-edge therapeutics, you need structural data that directly informs efficacy—not just stability. Creative Biolabs delivers tailored insights that accelerate your clinical path.
Our Advantage:
Customized LNP Efficacy Enhancement
Targeted structural analysis to confirm the therapeutic-enhancing inverse hexagonal (HⅡ) phase in your Lipid Nanoparticles, providing the physical evidence that correlates LNP structure to superior in vitro and in vivo delivery.
API Bioavailability Assurance
Precision identification and quantification of all API polymorphic forms to ensure consistent dissolution rates and bioavailability across batches, eliminating the risk of unexpected performance shifts during scale-up.
Orthogonal, High-Resolution Analytics
Access to a comprehensive, orthogonal analytical suite including high-resolution PXRD, DSC, CryoTEM & Tomography, meticulously tailored to your unique sample matrix, whether it's a small-molecule API or a complex nanostructure.
Rapid, Custom Method Development
We offer dedicated, rapid, custom method development and screening protocols designed specifically for challenging, low-volume, or novel chemical entities, guaranteeing timely and actionable data for your milestone deadlines.
Unified Structural Expertise
Benefit from Creative Biolabs' unique capability to bridge solid-state chemistry and nanostructure biology, providing unified, end-to-end structural control for both the drug product and the advanced delivery system.
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We use an integrated approach. For traditional APIs, we apply PXRD and DSC for solid-state characterization. For advanced delivery systems like LNPs, we employ specialized techniques like CryoTEM and Small-Angle X-ray Scattering (SAXS) to confirm the optimal liquid crystalline internal structure (e.g., the HⅡ phase), ensuring both the drug's solid state and the vector's delivery mechanism are controlled.
Yes, it is often critical. While your current batch may be stable, an undetected, less stable polymorph can be inadvertently generated during scale-up or under different formulation conditions. Our comprehensive screening helps you predict and prevent disastrous phase transformations, guaranteeing regulatory compliance and long-term shelf life before issues arise.
Absolutely. We specialize in developing validated quantitative PXRD methods to accurately measure low levels of polymorphic impurities. This is essential for meeting regulatory thresholds and demonstrating robust quality control over your manufacturing process.
Creative Biolabs is committed to solving the most challenging structural and formulation problems in biopharmaceutical development. Our Custom Crystallinity and Polymorphism Characterization Service provides the critical data needed to establish product consistency, mitigate regulatory risk, and confirm the optimal performance-driving structures within complex drug systems like Lipid Nanoparticles.
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