Helix Services

Lipid Nanoparticles (LNPs) and Liposome Samples. LNP and Liposome Formulation, Manufacturing, and Analytical Services. GMP Clinical or Pre-Clinical Research Use Only

Services Overview

Formulation Development and Screening

Sample Preparation and Analysis

Formulation Selection and Design

Optimization by DOE

Manufacturing Process Feasibility

Analytical Method Feasibility

GMP Process Development

GMP Manufacturing Process Design

GMP Manufacturing Process Feasibility

GMP Manufacturing Process Implementation, Engineering Batches

GMP Analytical Method Development

Compendial Analytical Methods (USP/ICH)

Custom Analytical Methods

Method Feasibility and Validation (USP/ICH)

GMP Manufacturing

Batch Production, Lot Release

Aseptic Fill/Finish (i.e. sterile glass injection vials)

Clean and Sterile Processing Rooms

Tech Transfer or In House Development

Validated Temperature Controlled Storage, Stability Programs

21 CFR Part 210/211 Compliant