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Glycotope

GlycoEngineering and Immunotherapeutics

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Glycotope

Glycotope Biotechnology offers GMP-compliant biotechnological contract manufacturing, based on animal cell culture systems in fed-batch or perfusion fermentation technologies. We are compliant with all criteria within the European Pharmaceutical legislation, the European Pharmacopoeia, as well as EU and ICH guidelines.

Upstream processing and cell culture

upstream-processing-pharma

Fermentation in a stirred tank fermenter is the most-used method of recombinant protein production in cell cultures.
Our core competencies:

  • Scale-up to production levels, fermenter volume (either stainless steel or SUB technology): 10-1,000L
  • Cultivation in perfusion mode: 12,500L batch size
  • Cell cultivation processes are performed in a monitored hygienic area corresponding to ISO class eight. Our facility encompasses four separate fermentation suites (corresponding to class D rooms)

Click here for more information.

Downstream processing and protein purification

Downstream processing is the recovery and purification of biopharmaceuticals, which is an essential step in the manufacture of recombinant biotherapeutics. This follows on from upstream processing, which is also known as fermentation.

Glycotope is able to perform the method development of protein capturing from harvest, through searching for convenient chromatography methods (IEC, SEC, HIC, RP, Affinity), in order to achieve an efficient removal of host cell protein (HCP), endotoxins and host cell DNA as critical impurities.

Glycotope supplies GMP-compliant purification processes to ensure the final product meets all regulatory guidelines. We conduct the purification of cell-free harvest in a monitored hygienic area, in accordance to ISO class seven (corresponding to class C rooms).

Our core competences:

  • Scale-up to pilot and production levels
  • Process validation according to GMP guidelines
  • Validation of viral safety
  • Production for clinical trials Phases I-III in accordance with GMP guidelines

Click here for more information.

downstream-processing-pharma

Pharmaceutical fill and finish

Glycotope’s fill and finish facility can be easily adapted to customers’ dosage, formulation and filling needs, thanks to its flexible set-up.

Sterile filling of aseptic solutions come in various glass vials with qualified staff, facilities and equipment.

Media fills are performed for new primary packaging systems and final filling is performed in a clean room with level ‘A in B’ standard. Subsequent to filling, we provide complete quality control through our protein analysis department.

Our core competencies:

  • Proteins as formulated pharmaceutical drugs
  • Semi-automated aseptic filling of up to 800 vials/batch
  • Labeling, packaging, and shipping of clinical samples
  • Compliance with FDA and EMEA standards

Click here for more information.

Cell line development and cell banking

cell-line-banking

Regulatory-compliant cell bank is an essential requirement for biotheraputic production. Cell banking guarantees that a uniform population of cells is preserved, that their integrity is maintained and that an adequate supply of material is readily-available for the life of the product. What is also equally important, is that these banks are maintained securely and that they are controlled in a monitored storage environment.

Glycotope’s cell lines fulfil all the necessary needs for the development of an optimal production process. Cell banking projects are performed in compliance with the relevant regulatory requirements. Cell banks are stored under GMP-conditions.

Our core competencies:

  • Development of serum free cell lines
  • Production and storage of master and working cell banks (MCB/WCB)
  • Characterisation of master and working cell banks

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Contact details

Glycotope Biotechnology GmbH
Czernyring 22
D-69115 Heidelberg, Germany
Phone: +49 (6221) 9105 0
Fax: +49 (6221) 9105 10
Email: info@glycotope-bt.com
Website: www.glycotope-bt.com

Protein Analytical Services

For demonstration and documentation of the batch-to-batch consistency of any given biopharmaceutical material, its identity, purity, quantity, bioactivity and profile of impurities must be confirmed.

These tasks are addressed by our portfolio of analytical routine methods for quality control of biopharmaceuticals, and complemented by qualified external partners. Thus, we are able to provide full quality control of biological APIs and clinical samples.Click on the following links for more information:Protein analyticsBioactivity and cellular assaysHost cell DNA assayHost cell contaminantsClick here for…

Bioassays

For more than 25 years BSL BIOSERVICE have provided the scientific and experimental know-how to design and perform tailor-made bioassays in close collaboration with their clients.

Their development, validation and performance of bioassays / potency assays is US FDA approved and can be offered according to GLP and GMP regulations. BSL BIOSERVICE conducts the testing of about 350 batches of client material per year using a diverse range of bioassay types (in vitro and in vivo bioassays).In Vitro BioassaysAssay TypesCell proliferationCell…

CMV – Tetramer TEST

Tetramers are one of the major key components that lead to the understanding of cellular immune responses. Tetramer technology has developed into a standard method for quantifying CMV specific T cell responses. We have developed a CMV-Kit, which allows enumeration of CMV-specific T cells in a small sample in full blood.

Monitoring CMV-specific T cells with tetramers in full bloodTetramers are one of the major key components that lead to the understanding of cellular immune responses. Tetramer technology has developed into a standard method for quantifying CMV specific T cell responses. We have developed a CMV-Kit, which allows enumeration of CMV-specific T cells in a small…

Contract Manufacturing Services

Glycotope Biotechnology offers GMP-compliant biotechnological contract manufacturing based on animal cell culture systems and perfusion fermentation technologies. These services are supported by research and development in immunology, cell biology, molecular biology and protein chemistry.

Based on the GlycoExpress technology of Glycotope GmbH, Berlin, we can offer the development and production of pharmaceutical proteins and antibodies in human cell lines with optimised glycosylation pattern.In our R&D departments work closely together with the scientists at the German Cancer Research Centre and the University in Heidelberg. In these fields our significant experiences…

Determination of Host Cell Contaminants

Host cell contaminants, such as host cell protein or host cell DNA, need to be detected using highly-sensitive methods. Glycotope uses commercially available or custom-made bioassays for the detection of host cell proteins. The level host cell DNA can be determined using threshold or RT-PCR techniques.

Host cell-derived proteins are detected either by generic assays or by special assays developed for the client-specific fermentation and purification scheme. The client-specific assays can be developed on standard ELISA format or for the more sensitive threshold system.Click here for more information.

Services in GlycoAnalytics and GlycoProfiling

Most pharmacologically relevant proteins (such as growth factors, cytokines, hormones and antibodies) are glycosylated. The correct human glycosylation and optimal sialylation of a recombinant protein are essential for its full bioactivity, half-life, stability or immunogenicity. To evaluate and realise the full therapeutic potential, Glycotope offers a broad range of state-of-the-art glycoanalytical and glycoengineering technologies.

Optimised Biopharmaceuticals – GlycoExpress

GlycoExpress is a regulatory approved platform technology for the development and production of NBEs and improved second generation biopharmaceuticals / BioBetters via targeted alteration of the glycosylation.

GlycoTechnologies

GlycoExpress (GEX) is a screening and high yield production platform based upon proprietary glycoengineered human cell lines for the generation of manifold improved antibodies and proteins with fully human and optimised glycosylation.

GT-MAB 2.5-GEX, GT-MAB 5.2-GEX and GT-GP 2.4-GEX

Based on GlycoExpress™, Glycotope develops new biological entities and 2nd generation products.

Immuno and Cell Services

The new European regulation "REACH" demands for tests to validate the harmlessness of about 30,000 already marketed chemicals. Manufacturers of ingredients for pharmaceuticals, cosmetics or food need to prove the absence of any cytotoxic, immunogenic or allergic potential.

Immunodiagnostics

Glycotope Biotechnology's product line of diagnostic reagent kits is based on flow cytometry procedures for the fast and precise measurement of various cell functions.

We offer a range of flow cytometry-based assays for the analysis of the functional activity of neutrophilic granulocytes, monocytes, basophilic granulocytes and natural killer cells:Clinical diagnostic for the quantitative determination of the chemotactic function of neutrophilic granulocytesClinical diagnostic for the quantitative analysis of leukocyte phagocytosis in human whole bloodClinical diagnostic for the quantitative analysis of…

Production of Monoclonal or Recombinant Antibodies

Production of monoclonal antibodies and antibody derivates can be carried out using a variety of mammalian cell lines, ranging from the widely-used CHO-cells to our proprietary human cells, ensuring a glyco-optimisation.

Systems used are either stainless steel fermenters, ranging from ten to 200 litres, or single use bioreactors, ranging from 20 to 1,000 litres. Upon our customers' request, these fermenters can be run in fed-batch, or perfusion mode.Click here for more information.

Production of Other Recombinant Biotherapeutics

As well as our expertise in the production of antibodies, Glycotope Biotechnology is continually producing a variety of other therapeutic molecules, such as cytokines and peptide hormones.

In our five independent USP production suites, up to five different products can be produced in parallel.Click here for more information.

Quality Control Assays

Very strict quality and product-safety regulations are entailed on products isolated from biological sources. These products are potentially contaminated by nucleic acids or proteins derived from the host cell system or other components used during cultivation and purification.

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