TASKCM: Providing Kilogram-Scale DOTAP Liposomes and Complete Registration Support Services
Oct 30, 2025
TASKCM: Providing Kilogram-Scale DOTAP Liposomes and Complete Registration Support Services — From Raw Material Supply to Regulatory Filing, a One-Stop Professional Solution
With the rapid development of nucleic acid drugs, gene therapy, and mRNA vaccines, the cationic lipid DOTAP has become one of the core structural components in various nucleic acid delivery systems (LNPs, liposomes, and composite nanoparticles) due to its excellent nucleic acid-binding capacity, membrane transfection efficiency, and biocompatibility.
However, as lipid-based delivery materials progress toward clinical and industrial applications, R&D organizations require not only high-quality lipid materials but also comprehensive analytical reports, regulatory certifications, and registration documentation to meet submission and compliance requirements.
Leveraging its extensive experience in lipid manufacturing, formulation development, and regulatory compliance, TASKCM now provides:
Kilogram-scale, high-purity DOTAP liposomes and lipid raw materials
DOTAP quality testing and analytical reports
DMF registration, filing support, and technical documentation services
Through an integrated system covering R&D – analysis – registration – scale-up manufacturing, TASKCM offers end-to-end support to research institutions and pharmaceutical companies, accelerating the transition of innovative drugs from the laboratory to clinical and commercial stages.
I. DOTAP Liposomes: A Key Component in Efficient Nucleic Acid Delivery Systems
DOTAP is a typical permanently charged quaternary ammonium lipid that forms stable complexes with negatively charged DNA, siRNA, and mRNA molecules. Thanks to its strong electrostatic binding, membrane fusion capability, and good physiological compatibility, DOTAP is widely used in:
mRNA vaccines and gene therapy: As a cationic lipid, DOTAP improves the encapsulation efficiency and cellular uptake of LNP systems.
siRNA delivery and gene silencing: DOTAP/siRNA complexes enable efficient intracellular delivery and gene knockdown.
Immunoadjuvant and antitumor applications: DOTAP liposomes can act as adjuvants to enhance antigen presentation and boost cellular immune responses.
With the rise of mRNA drugs and RNA interference therapeutics, the regulatory status and quality traceability of DOTAP have become critical considerations in early drug development.
II. TASKCM: Stable Kilogram-Scale DOTAP Liposome Production
As one of China’s leading functional lipid suppliers, TASKCM has established standardized production and quality control systems for lipid materials, achieving kilogram-scale stable production of DOTAP raw materials and DOTAP-based liposomes.
Product highlights:
High purity and batch-to-batch consistency
DOTAP purity ≥99%
Endotoxin level <0.25 EU/mg
Strict control of residual solvents and oxidation by-products
Customizable production
DOTAP raw material (powder or solution form)
Research-scale or pilot-scale DOTAP liposomes
Composite lipid systems (e.g., DOTAP/DOPE, DOTAP/Chol, DOTAP/siRNA)
Pilot and scale-up manufacturing support TASKCM’s lipid formulation platform covers microfluidics, thin-film hydration, and high-pressure homogenization processes, enabling seamless transition from gram-scale R&D to kilogram-scale pilot production.
III. Comprehensive Testing and Quality Characterization
To ensure that DOTAP products meet pharmaceutical R&D and regulatory filing standards, TASKCM has built a systematic quality testing and characterization platform, supporting clients with complete analytical data and reports covering every stage from structural confirmation to performance evaluation.
Key testing items:
Chemical purity: HPLC, GC analysis
Structural confirmation: ¹H-NMR, ¹³C-NMR, MS spectra
All testing follows relevant pharmacopoeia and regulatory guidelines (ChP, USP, EP, ICH Q6A/Q7A), providing strong technical and regulatory support for clients’ subsequent submissions.
IV. DOTAP Registration and Regulatory Filing Support
Once lipid carriers enter the preclinical stage, their raw materials must have traceable quality systems and registration documentation. TASKCM acts not only as a lipid supplier but also as a regulatory compliance partner for its clients.
Our professional services include:
DMF registration support
Preparation, translation, and filing of DOTAP-related DMF documents with regulatory authorities such as NMPA, FDA, and EMA.
Raw material filing and specification development
Assistance in establishing enterprise quality standards for DOTAP
Impurity profiling and stability study reports
Support for drafting CMC module documentation (e.g., 2.3.S section)
Technical review and submission guidance
Expert support for responding to technical queries and supplementary documentation requests during the review process
Project-specific support
For projects in pre-IND or Phase I stages, TASKCM can provide reference batches, method validation reports, and scale-up batch data.
With a deep understanding of DOTAP quality control, regulatory systems, and registration strategies, TASKCM helps clients shorten regulatory timelines, reduce trial-and-error costs, and ensure a smooth transition from technical development to compliant filing.
V. TASKCM’s One-Stop Service Platform
TASKCM aims to be a comprehensive CDMO partner in nucleic acid drug and lipid delivery research, providing an integrated service chain from raw material to formulation, testing, and registration.
Service Module
Service Content
Lipid Supply
Kilogram-scale production of DOTAP, DOPE, DPPC, Cholesterol, etc.
DMF registration, standard establishment, submission document preparation
Pilot Scale & Tech Transfer
Microfluidics, homogenization, lyophilization, sterile filtration process validation
Through this integrated system, TASKCM enables clients to rapidly progress from laboratory concepts to clinically traceable and scalable pharmaceutical lipid systems.
VI. Conclusion: Advancing Nucleic Acid Drug Innovation Through Professionalism
In the evolving field of nucleic acid therapeutics, the quality, compliance, and stability of DOTAP liposomes are critical to ensuring successful clinical translation.
By combining kilogram-scale DOTAP production capability, comprehensive analytical and certification systems, and expert regulatory support, TASKCM provides full-chain services from material development → analytical validation → registration filing → process scale-up.
With a systematic, professional, and globally oriented service platform, TASKCM continues to empower global partners to accelerate the industrialization of nucleic acid drugs and mRNA vaccines—driving next-generation drug delivery technologies toward higher standards and broader applications.
