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Crystallinity and Polymorphism

As an expert in the field of messenger ribonucleic acid (mRNA) studies, Creative Biolabs is helping our customers with various mRNA delivery services targeting crystallinity and polymorphism. Based on our deep analytical capabilities and vast experience in mRNA studies, our integrated team will anticipate challenges, overcome difficulties, and provide custom mRNA delivery vehicle studies with numerous assays. We guarantee the finest results for our customers all over the world.

Introduction to Lipid Nanopartical-Formulated Drug

Currently, liposome has become the most popular non-viral carrier for mRNA delivery, mainly including lipoplex (LP), lipopolyplex (LPR), liposome nanoparticle (LNP), and cationic nanoemulsion (CNE). Among them, LNP has been regarded as the mainstream delivery carrier for novel drugs specific for rare diseases and serious diseases such as cancer. It consists of an aqueous core surrounded by a lipid bilayer, which is made up of different lipids, each with a different function.

Although LNP has greatly promoted the development of new drugs, there are still many deficiencies. Nanoparticles are relatively large in size and generally need to be injected into tissues with large spaces such as the liver, spleen, and tumors through intravenous injection. In addition, LNP can also cause severe allergic reactions, which need to be controlled by antihistamine and hormone drugs before injection. Therefore, it is particularly important to evaluate the stability, bioavailability, and efficacy of LNP-formulated drugs.

X-ray diffraction patterns and crystallinity indices (C.I.) of the original squid pens and β-chitin nanofibrils. Fig.1 X-ray diffraction patterns and crystallinity indices (C.I.) of the original squid pens and β-chitin nanofibrils. (Wu, 2019)

Our Services for Crystallinity and Polymorphism Evaluation

Different crystal types of the same LNP drug may have significant differences in appearance, solubility, melting point, and dissolution, thus affecting the stability, bioavailability, and efficacy of the drug. As a result, drug crystallinity polymorphism is one of the important factors for drug quality and clinical efficacy. With the commitment of being your best mRNA delivery vectors development partner, Creative Biolabs has established the utmost efficient integrated crystal and polymorphism analysis solutions to facilitate the discovery of new delivery vehicles for mRNA.

Methods for Crystallinity and Polymorphism Detection

Equipped with a team of professional scientists, we have generated a group of crystallinity and polymorphism detection systems, including but not limited to, X-ray diffraction assay, infrared absorption spectrum detection system, melting-point microscopic assay, differential scanning calorimeter (DSC) assay, as well as nuclear magnetic resonance (NMR) system. For example, we have evaluated several new polymorphic forms of LNP-formulated drugs and optimized their crystallinity by using X-ray diffraction technology. In our labs, we usually choose an optimal method for LNP-based crystallinity and polymorphism detection, and if necessary, we can use multiple assays to identify them from different angles. Besides, we also provide content determination services for active crystal types in LNP-formulated drugs or preparations. The curative effect of the drug can be guaranteed by establishing a suitable polymorph quantification method. In a recent study, our X-ray powder diffraction (PXRD) system has been used in quantitative analysis and crystallinity of mixtures of different crystal types.

Creative Biolabs is dedicated to expanding cutting-edge mRNA research across a range of applications. With our proven competencies and regulatory expertise, we are therefore confident in offering the best crystallinity and polymorphism services for mRNA delivery. We can provide many flexible options, from which you can always find a better match for your particular project. If you are interested in our services, please contact us for more details.

Reference

  1. Wu, Q.; et al. High strength nanostructured films based on well-preserved β-chitin nanofibrils. Nanoscale. 2019, 11(22): 11001-11011.
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