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Liposome Quality Control and Testing

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Despite the growing interest in nanodevices and nanomedicines over the past two decades, challenges remain in the development and quality control of nanoscale systems due to their inherent complexity. One of the primary hurdles in liposome drug product development is accurately identifying and characterizing key quality attributes, alongside implementing suitable control strategies. CD Formulation aims to support customers in accelerating and optimizing the development of liposome formulations by addressing these critical areas.

Importance of Liposome Quality Control and Testing

Nanomedicine is a rapidly evolving and increasingly specialized field. Liposome-based formulations serve as a key platform in nanomedicine. Despite the outstanding performance of liposomes, the complexity associated with their formulation, product development, and manufacturing poses clear challenges. The heightened intricacy of nanomedicine formulations/nanomanufacturing arises from the unique physical and chemical properties at the nanoscale, necessitating a deeper understanding and optimization of multiple variables. Evaluating the critical quality attributes (CQAs) of liposome drug products, including their physical and chemical properties, composition, encapsulation efficiency, and drug release from liposome formulations, as well as establishing product specifications for the drug, is essential in the process of drug development.

Fig.1 Diagram illustrating the critical role of quality control in liposome production. Fig.1 The significance of liposome quality control. (Giordani S, et al., 2023)

Our Liposome Quality Control and Testing Services

Items	Specifics
Liposome Analytical Method Development and Validation	Our pharmaceutical analysis platform adheres to ICH guidelines and national pharmacopeia standards. We provide thorough method development and validation services covering raw materials, intermediates, and API R&D.
Liposome Analytical Method Transfer	Our expertise includes various method transfer scenarios: a. Transferring from R&D laboratories to quality control (QC) laboratories b. Relocating laboratories or moving QC methods to in-process control labs on production lines c. Transferring methods after product acquisition or between production facilities at different locations d. Outsourcing testing
Liposome Residual Solvent Analysis	With over 100 successful cases, our quality research team offers efficient strategies for controlling residual solvents, guided by the ICH Q3C framework. We ensure comprehensive solutions tailored to liposome formulation development needs.
Liposome Impurity Analysis	We provide comprehensive impurity profiling, integrating assessments of raw materials, manufacturing processes, and impurity degradation (including organic and inorganic impurities).
Liposome Stability and Storage Testing	We address liposome stability from three aspects—physical, chemical, and biological: Physical Stability: Ensuring equilibrium of interaction forces within and between liposomes to prevent aggregation. Chemical Stability: Addressing oxidation and hydrolysis challenges. Biological Stability: Analyzing factors such as lipid composition, morphology, and drug delivery routes.
Liposome Batch Release Testing	Considering the complexity of in vivo drug release from nano-liposomes, we design in vitro release studies that simulate physiological conditions, accounting for administration route, transport, and release environment.
Liposome Freeze-thaw Testing	The freeze-thaw method enhances liposome synthesis, promoting uniform assembly. This process involves freezing formed liposomes using liquid nitrogen, where ice crystals puncture the lipid membrane, followed by reconstitution during thawing.

Why Choose CD Formulation?

Robust Quality Control Platform: Equipped with advanced analytical instruments, our platform ensures comprehensive product monitoring and testing that meets industry standards.
Expert Analysis Team: Our experienced team possesses deep industry knowledge and hands-on expertise, delivering reliable, high-quality solutions tailored to customer needs.
Flexible Service Models: We offer adaptable services, including tailored solutions, to address specific customer requirements, providing prompt and convenient support.

As a leader in nanoparticle technology, CD Formulation is committed to providing professional liposome quality control and testing services. Contact us for expert assistance in your liposome formulation projects.

References

Giordani S, Marassi V, et al. Liposomes characterization for market approval as pharmaceutical products: Analytical methods, guidelines and standardized protocols. Journal of Pharmaceutical and Biomedical Analysis. 2023 Sep 27:115751.

How It Works

STEP 1

Submit a service request describing your specific research or development need.

STEP 2

We'll email you to provide your quote and confirm order details if applicable.

STEP 3

Execute the project with real-time communication, and deliver the final report promptly.

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