Identity Purity Content Impurity Physiochemical Functionality / Potency Immune cell assays

Analytical methods

SYMBIOSIS solutions are customer-driven sets of analytical methods, designed to meet regulatory requirements. An extensive range of methods combined with our expert knowledge provides accurate analysis and consistent results in accordance with GMP and GLP requirements. SYMBIOSIS solutions are designed to accelerate drug product development and to provide analytical support throughout drug product life cycles.

Analysis of drug substances and drug products of (bio-)pharmaceuticals and classical pharmaceuticals
Stability testing according to ICH guideline Q1A-F and Q5C, incl. storage
Release testing

Development and validation of analytical methods in accordance with ICH Q2 guideline
Comparability testing (incl. Biosimilars/Biobetters)
Safety testing

Identity

Identity testing provides clear and reliable confirmation of (bio-)pharmaceuticals, ensuring integrity and consistency throughout development and quality control.

Protein sequencing

(N- and C-terminal)

Mass spectrometry

(MALDI-TOF-MS)

Peptide mapping

Spectometry

(UV-VIS, IR, Fluorescence)

Isoelectric focussing

(IEF)

Western blot

Purity

Our purity testing delivers fast and reliable insight into the molecular integrity and homogeneity of (bio-)pharmaceutical products, supporting research, development, and quality control.

Size exclusion chromatography

(SEC)

Ion exchange chromatography

(IEX)

SDS-PAGE

Thin layer chromatography

Content

Content testing delivers precise quantification of (bio-)pharmaceutical samples, providing critical insight for safe and effective (bio-)pharmaceutical products.

RP-HPLC

Protein determination

(CBB, BCA, UV)

ELISA

Titrimetry

Sialic acid determination

Dissolution testing

Impurity

Impurity testing identifies and monitors contaminants to ensure the safety and quality of (bio-)pharmaceutical products.

Size exclusion chromatography

Ion exchange chromatography

SDS-PAGE

Physicochemical

Physicochemical testing provides precise information on the fundamental physical and chemical properties of (bio-)pharmaceuticals, supporting reliable product development and quality control.

Colour

Clarity/Opalescence

Visible particles

pH

Residual moisture

Loss on drying

Resistance to crushing

Functionality / Potency

Functionality testing verifies drug effectiveness to support development and optimization.

Bioassay

Dissolution testing

Immune cell assays

Immune cell-based assays are essential tools for assessing immune functionality, signaling and biological activity in pharmaceutical products, drug discovery and development.

For more information, please visit our service page.

PBMC assays

Cytokine release

T-cell activation

Immune proliferation

Antigen presentation

Innate immunity

NK-cell activity

Modern laboratory infrastructure

Our laboratory relies on a wide range of specialized analytical instruments to support you with your products. This diverse infrastructure covers all key methods required for classical pharmaceutical testing. Regular internal and external performance checks ensure consistent precision and reproducibility, reflecting both our technical expertise and our commitment to reliable, high-quality data.

Our equipment includes:

Company	Instrument
Shimadzu	PPSQ-51A
Applied Biosystems	PROCISE
Agilent	HPLC
Bruker Daltonik	MALDI TOF MS Microflex LT
Sartorius	Incucyte
Metrohm	KF-Titrino 701
Tecan	SUNRISE-BASIC TECAN
Agilent	Cary 60
N-Biotek	vacuum-concentrator NB-503CIR
Gonotec Osmometer	Osmomat 3000-D
Memmert	conditioning cabiet type HPP260eco

Contact us