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Analytical Methods

A wide range of analytical methods is available for testing of intermediates, APIs and finished drug products. They can be readily adapted for new products. Qualification and validation of analytical methods for each project are performed according ICH guidelines.
A list of the main methodological groups is given below. Additional methods are organised with qualified contract analytical laboratories.

Liposomes/LNPs

  • size / size distribution (polydispersity index)
  • zeta potential

Microbiology

  • sterility
  • bioburden

Electrophoresis

qualitative and semi-quantitative using a wide range of detector systems, e.g. fluorescence, chemiluminescence

  • sodium dodecylsulfate polyacrylamid gel electrophoresis (SDS-PAGE)
  • isoelectric focusing (IEF)
  • Western blot

Microtiter Assays

  • enzyme linked immunosorbent assay (ELISA)
  • protein activity assay
  • endotoxin
  • enzyme activity assay

Instrumental Analytics

all conventional separation methods in combination with various detector systems (e.g. CAD, UV, refractive index, fluorescence)

  • high performance liquid chromatography (HPLC), e.g. SEC, AEX, CEX, RP, IP/RP
  • capillary electrophoresis (CE)
  • optical density (OD)
  • fourier transform infrared spectroscopy (FTIR)
  • fluorescence spectroscopy
  • photon correlation spectroscopy
  • zeta potential

In Vitro Test Systems

  • proliferation assays, e.g. using MTT, XTT, BrdU

Others

  • osmolality
  • conductivity
  • pH
  • density
  • residual moisture (Karl Fischer)
  • visual appearance
  • TOC

Analytical Methods

MEET US AT

CRS Germany, Bad Dürkheim, Germany, February 29 - March 1, 2024

Daniel Kumar, Thomas Vrucina
 

European Symposion on Controlled Drug Delivery, Egmond aan Zee, Netherlands, April 10-12, 2024

Dr. Andreas Wagner
 

TIDES USA, Boston, USA, May 14-17, 2024

Thomas Vrucina, Dr. Andreas Wagner
 

Applied Biophysics Forum
in Drug Delivery, Copgenhagen, Denmark, May 27-28, 2024

Dr. Andreas Wagner
 

Levitronix Bioprocessing Conference, Cambridge MA, USA, June 20, 2024

Dr. Andreas Wagner
 

Liposome Research Days, Glasgow, UK, June 26-29, 2024

Thomas Vrucina, Dr. Andreas Wagner
 

mRNA Health, Boston, USA, November 12-14, 2024

Thomas Vrucina, Dr. Andreas Wagner

 

DOWNLOAD LIPOSOMAL BROCHURE

Polymun Liposome Technology 
Broschure (pdf, 1MB)