
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.
Consultation
Project
Design
Manufacturing
& Process
Development
Feasibility
Analytical
Testing
Implementation
Audit Support
Technology
Transfer
Clinic
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 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

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)
