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 gained over time from a large number contract research projects are of major advantage for our clients.

Additional R&D services offered include transfection, clone selection and cell line development, MCB and WCB establishment and characterisation, product characterisation, validation studies and process optimisation.

Glycotope Biotechnology complies with all criteria specified by the European Pharmaceutical legislation, the European Pharmacopoeia, and the EU and ICH guidelines.

Upstream Processing / Cell Culture

Glycotope Biotechnology offers GMP-compliant biotechnological contract manufacturing based on mammalian cell culture systems and perfusion fermentation technologies. These services are supported by research and development in immunology, cell biology, molecular biology and protein chemistry. Beside production in customers’ own cell lines, we can offer the Glyco-Express technology of Glycotope GmbH, Berlin.

This technology enables an optimised glycosylation pattern and high batch-to-batch consistency of pharmaceutical proteins and antibodies by using our proprietary human cell lines.
GMP Compliant Cell Culture Production

Fermentation in a stirred tank fermenter is the most 
wide-spread method for the production of recombinant proteins in cell cultures. Various methods such as batch, fed-batch, repeated batch and perfusion are well established at Glycotope Biotechnology.
All methods used for development can be performed under GMP conditions.

Our Core Competencies:

• Scale-up to production levels, fermenter volume: 10 – 300 Liter
• Cultivation in perfusion mode: 7,500 Liter batch size
• Cell cultivation processes are performed in a monitored hygienic area corresponding to ISO class 8. Our facility encompasses 4 separate fermentation suites (corresponding to class D rooms).

Downstream Processing/ Protein Purification

Downstream processing is the recovery and purification of biopharmaceuticals. It is an essential step in the manufacture of recombinant biotherapeutics, which follows the upstream processing, also called fermentation.

Development of Purification Process

In the development of Downstream Processes (DSP), the structural and functional parameters of the recombinant protein must be retained while simultaneously all potential contaminants are removed. We can perform the method development for protein capturing from harvest, through scouting 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.

GMP Compliant Purification of Proteins

We offer GMP compliant purification processes to ensure the final product meets all regulatory guidelines. Glycotope Biotechnology performs the purification of cell-free harvest in a monitored hygienic area corresponding to ISO class 7 (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

Fill and Finish

The approval for Fill and Finish of clinical grade material allows GLYCOTOPE BIOTECHNOLOGY to provide its customers with a complete service "from the gene to the drug" at highest technological level.

Production of Clinical Samples

Through its highly flexible setup, the Glycotope Biotechnology Fill and Finish facility can be easily adapted to the customer’s dosage, formulation & filling needs. Sterile filling of aseptic solutions in various glass vials with qualified personnel, facilities and equipment. Media fills are performed for new primary packaging systems. Final filling is performed in a clean room with level „A in B" standard. After 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 500 vials/batch
• Labeling, packaging, and shipping of clinical samples
• Compliance with FDA and EMEA standards

Cell Banking

The generation of a regulatory-compliant cell bank is an essential element in the production of biotherapeutics. Cell banking assures that a uniform population of cells is preserved, that their integrity is maintained and that a sufficient supply of material is readily available for the life of the product. Of equal importance is the maintenance of these banks in a secure, controlled and monitored storage environment.

Cell Line Development

• Adaptation of cell lines to serum free media
• Conversion of adherent growing cells into suspension cell lines
• Optimisation of glycosylation pattern

Generation of Cell Banks

The cell lines developed by GLYCOTOPE GmbH, Berlin fulfill all pre-requisites for the development of an optimal production process. Cell banking projects are performed in com-pliance 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)
• Characterization of Master and Working Cell Banks