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Glycotope - Contract Manufacturer of Recombinant Proteins

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)

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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

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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

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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