ProBioGen AG

Goethestraße 54
Berlin, 13086
Germany

Phone: 0049 30 924006 -0
Fax: 0049 30 924006-19
E-Mail: This e-mail address is being protected from spam bots, you need JavaScript enabled to view it
Please notice: This entry hasn't been updated by the submitting company for more than 2 years. It could be possible that this company doesn't longer exists.

Description:

Company Profile

ProBioGen is a  Contract Development and Manufacturing Organization (CDMO) and Technology Provider, with extensive expertise in cell line engineering, process development (upstream- and downstream process) and GMP manufacturing of biopharmaceuticals.

We are the partner of choice to assist our clients to successfully develop and manufacture their biopharmaceutical drug product candidate.

ProBioGen provides individual, state-of-the-art service packages (from cell lines to comprehensive biopharmaceutical manufacturing programs) coupled with proprietary technology platform offerings, to permit the optimization of biopharmaceutical production processes. Our technology innovations offer enhancement of cellular productivity and yield and improvements in product potency, quality and safety.

Our cutting-edge development services in combination with our quality manufacturing solutions enable your drug candidates to reach their full potential reliably and in a rapid timeframe.

Services and Technologies

Cell line development

- High producer cell lines for the manufacturing of biologics (monoclonal antibodies, antibody fragments, enzymes, cytokines, fusion proteins)

- Pre-adapted CHO starter cell line: fully documented, genetically stable, conditioned to medium free of animal components, fully accepted to authorities

- Careful vector design combined with the use of novel promotors: gene-, transcript-, signal peptid optimisation

- Fed batch analysis

- Bioreactor suitability studies

- Free of third party rights

Designer cell lines: AGE1.Cell Lines

- Adressing requirements such as rising demand, cost effectiveness and safety profile in the manufacturing of vaccines, glycoproteins and antibodies

- Key strenghts: complete documentation, safety profile, productivity

- Developed to replace primary chicken cells and eggs in vaccine production

- Entire development in a dedicated GMP suite

- Master Cell Bank and ´EOP` Bank laid down

- Characterised and tested according to EU and US guidelines

- Exceptionally high titers for influenza viruses and pox vectors

- Proprietary rights to MVA production in duck cell lines

Process Development & Manufacturing

 - Process development and GMP manufacturing of biopharmaceutical drug substances for toxicological and clinical studies using disposable systems

- Manufacturing capacities up to 500 L (capacity extension underway)

- Cultivation systems: stirred tank and perfusion reactors

- Cultivation methods: batch, fed batch, continious methods

- Manufacturing authorisation from the competent authority according to German Act on Medicial Products (§ 13 AMG) for GMP manufacturing of biopharmaceutical drug substances

- ISO 9001:2008 and ISO 13485:2003 certrified

- Laboratories classified as BSL1, BSL2

- Services offered include:

• Process development (upstream/downstream)
• Cell banking, tox manufacturing
• GMP manufacturing and release
• regulatory support

Cell-based Assays & Services

- Broad range of analytical services including cellular analytics and cell-based assays for product characterisation (product potency, functionality and mode of action analysis)

- Cellular analytics, cell preparation & characterisation

- Immunogenicity and immune functional testing using the proprietary in vitro human Artificial Lymph Node model:

• Predictive of desired and undesired immune properties of chemical and biological substances (preclinical testing: e.g. risk evaluation, dose finding)
• Facilitates early decision making in lead optimisation 

Last update of this entry: June 29, 2011