Our process development services are enhanced by extensive work in immunology, cell biology, molecular biology and protein chemistry.

From intense work on the development of our own pipeline products we have acquired a very broad portfolio of analytical methods. This we bring in into our service offering for our clients.

Process Transfer and Process Development

Processes can be transferred from any other development or manufacturing site.

We develop upstream processes (USP) and downstream processes (DSP) using a platform or a customized variation. We are experts in perfusion and fed-batch processes, including their characterization and validation. We use all state-of-the-art technologies (2 Ambr-systems, batteries of small-scale bioreactors from 1 to 10 L working volume) in USP development. Corresponding machines from GE (Äkta Avant series) are available in our laboratories.

Analytical Services and Stability Studies

Glycotope Biotechnology has a proven track record in customized bio-analytical method development, qualification, validation and routine application. Its facilities, including equipment and instrumentation, are certified under Good Control Laboratory Practice, GCLP. Regulatory authorities worldwide accept our analyses and reports. In addition, Glycotope Biotechnology offers a comprehensive validation program in accordance with ICH Q2A (R) guidelines. The validation data can be reviewed at our facility in the context of a client audit. To ensure consistently high quality, our quality assurance systems are regularly audited.

Glycotope Biotechnology’s Analytical Services strongly support customers for specific biological assay development at any point along the product development path. We provide fully GMP-compliant analytical services and work together with our clients to develop and set-up efficient first-class quality control management to ensure the highest product quality and to help reduce the overall time and cost of product development.

Our portfolio of analytical routine methods for quality control of biopharmaceuticals includes identity, purity, quantity, bioactivity, profile of impurities etc. Qualified external partners complement these services. Thus, we are able to provide full quality control of biological API’s and clinical samples.

 

The services include:
  • Development of various analytical services including identity, purity and potency testing
  • cGMP compliant method validation and transfer
  • Performance of stability studies according to ICH guidelines

Purity Tests

  • HPLC (SEC, IEC, RP)
  • Endotoxin content (LAL-test)
  • Host cell protein assay ( Threshold® and ELISA)
  • Host cell DNA assay ( Threshold®)
  • Host Cell Contaminants, e.g. Protein A, HSA,
  • Insulin (ELISA)
  • Bioburden
  • Virus testing
  • Residual solvents (GC)
  • Sterility
  • Determination of water content

Quantification Tests

  • Protein determination (Bradford, BCA)
  • UV/Vis spectroscopy
  • ELISA,
  • HPLC (SEC) and FPLC (Affinity)

Identity Tests

  • Western blotting
  • SDS-PAGE
  • Isoelectric focusing
  • Mass spectrometry
  • Monosaccharide analysis

Potency Tests

  • Bioactivity assays
  • Specific binding assays. For more information please see our page “bioactivity and cellular assays”

General Tests

  • Appearance
  • pH
  • Osmolality
  • Ion chromatography

Host Cell Contaminants Assay

Our Core Competencies

  • Development of sensitive and robust host cell contaminant assays
  • Development of process and product specific pretreatments
  • Validation according to regulatory guidelines (ICH Q 2 (R1))
  • GMP-compliant product release testing
  • Short turn-over time
  • Client dedicated service


Host Cell DNA Assay

Using the Threshold Total DNA Assay™ (Molecular Devices) it is possible to perform the quantitation of residual DNA with high precision and sensitivity (up to 4 pg/ml).

Host Cell Protein Assay
The sensitivity of this technology is usually below 10 ppm.