Protein characterization

Analytic of proteinogenic drugs

There is a growing need in society for new therapeutic approaches in the form of biopharmaceuticals such as proteinogenic agents, antibody conjugates and immunotherapies for the treatment of serious and rare diseases. For this reason, investments are being made in the rapidly developing field of biologicals with the aim of advancing the development and production of biopharmaceuticals.

The production and release of biologicals is a challenging process, mainly due to the highly complex protein structures of these molecules. These complex structures require a high level of expertise, both in production and in quality control, which forms the basis for the release of the products. For the latter, specialized primary and secondary reference standards and analytical equipment, particularly in the field of mass spectrometry, are essential in addition to expert knowledge of analytics. The technology in this area is developing rapidly and requires regular investment. GBA Group stays up to date for you and operates an extensive pool of highly specialized analytical equipment. GMP-compliant qualified instruments are available for analysis.

The GBA Group is one of the few laboratories with a GMP qualification for the Orbitrap Exploris from ThermoFisher Scientific. Measurements can be carried out with the GMP and cGMP quality standard.

Our Services

GMP Testing
GMP Quality Control
Method Development & Validation
Dissolution

Extractables & Leachables

Particle Determination

Elemental Impurities Testing

Regulatory Services

Amino Acid Analysis

N-nitrosamines

qPCR

Protein Characterization

Bioassay

Stability Studies

Packaging Material Testing

Microbiology

Instrumentation

cIEF

Limit test for DEG and EG by GC

The experienced and highly committed GBA Pharma Labs team offers a variety of different services in the following Areas.