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
We focus on delivering affordable, high-yielding encapsulation processes, equipment, and reagents. Our staff has years of proven experience in formulation, analytical testing, and development of manufacturing systems and processes in the field of nanoparticle drug delivery. From proof-of-concept to GMP manufacturing, Helix Biotech has a unique set of capabilities to make your project successful. End-to-end or customized service packages are available for projects ranging from Research-Use-Only to GMP specializing in 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 formulate, develop, and screen formulations with nanoparticle sizes ranging from 10-500 nm. We have extensive experience in the creation of lipid nanoparticles, liposomes, emulsions, and polymer or polymer/lipid nanoparticles. Our formulation chemists design materials with ADME/PK in mind to create functional particles resulting in efficient delivery of a myriad of payloads – small molecule drugs, nucleic acids and oligos (RNA & DNA), and proteins and peptides. We design your formulation with the end goal in mind, whether you are looking for small volume samples for proof-of-concept or large-scale multi-liter GMP production.
GMP Analytical Method Development
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Compendial Analytical Methods
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Customized Analytical Methods
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Method Transfer
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Method Feasibility
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Method Verification, Qualification, and Validation
Contract Manufacturing
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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.
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Batch Production & Lot Release
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Aseptic Fill/Finish – sterile glass/plastic injection vials
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Technology Transfer
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Qualified cold-storage and stability study chambers
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21 CFR Part 210/211 and ICH compliant operations
Analytical Services – Physiochemical Analysis
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Particle Size/PDI by DLS (Dynamic Light Scattering)
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Zeta Potential by DLS
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Nucleic Acid Concentration and Encapsulation Efficiency (UV, Fluorescence)
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HPLC for compound concentration and purity
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pH
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Osmolality
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Viscosity
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Residual Solvents
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RNA/DNA Integrity by Electrophoresis (Agarose gel/CE)
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.
