Cell Banks: Master Cell Bank, Working Cell Bank

Process Development for the Manufacturing of Glycoproteins

GMP Manufacturing of Glycoproteins for Toxicological and Clinical Studies

Monoclonal Antibodies for Research and Diagnostics

ProBioGen can look back on 10 years of experience in processing more than 300 cell lines and is proud of its very satisfied customers. During this period, the company has produced diagnostic and therapeutic proteins of the highest qualities. Our customers value not only our extensive experience in manufacturing, but also the individual, flexible and solution-oriented approach of our project teams.

Whether in cell banking, process development or GMP manufacturing, our GMP experts accompany our customers closely and provide them with advice on all manufacturing aspects relevant to EMEA and FDA.

Effective project management combined with open communication belongs to ProBioGen's core competence.

Cell Banks: Master Cell Bank, Working Cell Bank

The most important issue in a cell bank used for manufacturing biological Active Pharmaceutical Ingredients is the compliance with the GMP (EMEA) and cGMP (FDA) guidelines.

To achieve this, the parameters for the manufacturing of cell banks are optimised specifically to each cell line. Using these parameters, a custom-specific master formula is developed and inspected by our Qualified Person. This master formula is released on compliance with all current aspects of GMP. The cells are cryo-preserved according to state-of-the-art technology in a controlled and documented process, using an automated cryopreservation machine. The whole process is performed without the use of serum. A GMP storage capacity for 9,600 cryogenic tubes is available in a controlled and documented liquid nitrogen gas phase storage facility.

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Process Development for the Manufacturing of Glycoproteins

Process: Depending on the properties of the glycoprotein, a fed-batch process or a continuous process is advisable. While fed-batch processes are widely used, continuous processes offer further advantages, if the product quality or the cell productivity can be enhanced by continuously removing the product from the fermenter.

Experience: With regard to process development and fermentation, extensive experience is available at ProBioGen concerning all relevant glycosylated protein classes: monoclonal antibodies, cytokines, enzymes and fusion proteins.

Cell culture media: Besides using customary off-the-shelf-media, ProBioGen offers the cell-specific GMP compliant optimisation of media components to further increase the process yield.

Fermentation and Purification: Process yield, product quality and process safety are given priority during the development of these processes. In-depth knowledge in fermentation technology and protein chemistry are integrated into the processes. A formulation study and a virus depletion study can also be performed on request.

Analytic: glycosylation analyses specific to the product and activity assays can be developed complementary to the standard fermentation and purification in-process controls. Furthermore, a wide range of methods are available to measure stability, integrity, purity and identity of glycosylated proteins.

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GMP-Manufacturing of Glycoproteins for Toxicological and Clinical Studies

ProBioGen produces biological API according to GMP-guidelines. The manufacturing facilities have a Quality Management System according to ISO-DIN 9001:2008 and are certified according to the EU-Guidelines, which is also FDA-conform, for the manufacturing of investigational medicinal products.

As ProBioGen possesses a multi-product facility and GMP production capacities up to 600L scale, the company is ideally suited to the manufacturing of glycosylated proteins for pre-clinical and clinical studies I and II.

All materials used in the manufacturing processes are monitored by a centralised incoming goods inspection system and controlled by an independent Quality Control department.

The utilisation of disposable bioreactors and state-of-the-art chromatography and filtration equipment combined with systematic hygiene monitoring secures the manufacturing of glycosylated proteins of the highest purity and quality. The Qualified Person releases the product only if all quality inspections of the product and the master formula are in accordance with the specifications.

Besides offering manufacturing services, ProBioGen's project teams advise the customer in all GMP-relevant issues and provide product- and process-specific documentation, such as the CMC part of the CTD, which is necessary for obtaining the permission to perform clinical studies.

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Monoclonal Antibodies for Research and Diagnostics

At ProBioGen, we use robust and economical techniques to produce high quality monoclonal antibodies.
Since 1994, we have processed over three hundred customer cell lines to produce monoclonal antibodies, recombinant proteins; and other mammalian cell-derived products. ProBioGen is a DIN ISO 9001:2008 certified contract manufacturer. For the manufacturing of monoclonal antibodies for research and diagnostics, we offer the following services:

• Media selection and adaptation to serum free media
• Recloning and productivity testing
• Cultivation in scales from 96 well-plate to 100L fed batch to produce up to gram quantities of monoclonal antibodies.
• Purification using filtration and affinity (Protein A, G, L), IE, HIC, RP and SEC chromatography.
• Process and cell analytics: Mycoplasma, sterility, 24h productivity assay, SDS / native page and others.
• Cell banking: up to 24,000 cryotubes in a monitored cryo environment.

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