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CDMO Services

We are a full-service nanoparticle development and manufacturing CDMO serving customers with R&D, Pre-Clinical, and Clinical project needs.

Partner with Helix

Helix Biotech specializes in providing cost-effective, high-yield encapsulation solutions, along with cutting-edge equipment and reagents. Our team boasts years of proven expertise in formulation, analytical testing, and the development of manufacturing systems for nanoparticle drug delivery. We offer a comprehensive range of services, from proof-of-concept to GMP manufacturing, with a unique skill set to ensure your project's success. We offer both end-to-end solutions and customized service packages, catering to projects spanning Research-Use-Only to GMP, with a focus on lipid nanoparticles, liposomes, emulsions, polymers, and dendrimers.





& Process






Audit Support




Formulation, Development, and Screening

We specialize in formulating nanoparticles (10-500 nm) like lipid nanoparticles, liposomes, emulsions, and polymer-based particles. Our experienced chemists prioritize ADME/PK considerations to optimize delivery for drugs, nucleic acids, proteins, and peptides. We tailor formulations for various scales, from proof-of-concept samples to large-scale GMP production.


GMP Process Development

We partner with you to develop your processes while transferring that knowledge to your staff through training and support. The processes are developed alongside our clients and fully owned by them once complete.


GMP Analytical Method Development

  • Compendial Analytical Methods 

  • Customized Analytical Methods  

  • Method Transfer 

  • Method Feasibility

  • Method Verification, Qualification, and Validation


Contract Manufacturing

  • Dedicated clean and sterile processing facilities – your project will be assigned to one of our dedicated clean room suites through the entirety of the manufacturing and filling process.  

  • Batch Production & Lot Release  

  • Aseptic Fill/Finish – sterile glass/plastic injection vials    

  • Technology Transfer 

  • Qualified cold-storage and stability study chambers 

  • 21 CFR Part 210/211 and ICH compliant operations

Signing Contract

Analytical Services – Physiochemical Analysis

  • Particle Size/PDI by DLS (Dynamic Light Scattering)

  • Zeta Potential by DLS

  • Nucleic Acid Concentration and Encapsulation Efficiency (UV, Fluorescence)

  • HPLC for compound concentration and purity

  • pH

  • Osmolality

  • Viscosity

  • Residual Solvents

  • RNA/DNA Integrity by Electrophoresis (Agarose gel/CE)

Lab Experiments

Consulting Services

Are you working on developing nanoparticles in your own lab and need help getting set up? Having issues with process development and formulation? Contact us, and we can help get your project on the right track. 

Business Handshake
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