Vaccines and Biopharmaceuticals Cell lines, Processes and Products

  • microbial cell line and process development

  • VLP based vaccines

  • ready-to-transfer processes

  • technology transfer and implementation support

  • protein analytics

  • manufacturing of preclinical and clinical material

News

Biosimilars

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Head of Molecular Biology at ARTES

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Features of ARTES´ Hansenula polymorpha protein production platform

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Cell Line Development

The focus of our tailor-made offer is on microbial production cell lines based on yeast (Hansenula, Pichia and Saccharomyces) and bacteria (E. coli). To meet customer’s demand,  ARTES Biotechnology develops the most efficient solution for the target of choice.

A transparent, well defined project design is agreed with our client prior to the start of the project, defining deliverables, timelines, milestones, Go/No-go decision points and costs.

A typical project starts with newly synthesized genes optimized for the respective host and providing a well defined origin for later registration. Within 6 – 8 weeks a first answer on feasibility of expression and protein localization is delivered and a mutual decision is taken on the progress of the cell line development. Next steps may include optimization of expression and/or secretion, generation of stable cell lines, selection of production cell line(s) for transfer to the client resp. for further process development at ARTES, genomic characterization and preliminary high cell density fermentation.

ARTES‘ offer includes:

  • feasibility studies
  • production cell line development
  • cell bank generation, characterization and transfer

Process Development

The fermentation process is one of the major cost drivers in industrial production. The fermentation processes developed at ARTES are based on low-cost, fully synthetic media avoiding expensive additives (e.g. methanol or IPTG) and aiming at short production times (approx. 45 – 75 hrs. for yeast; approx. 24 hrs. for E. coli). High productivity obtained with ARTES´ technologies directly translates into savings in energy, investment, consumables and waste.

Up- and downstream process development is designed right from the start to meet cGMP and large scale requirements in later-on routine manufacturing. Special emphasis is given on reproducibility and cost reduction. In-process control and final characterization of the product and of host/process related impurities are included in our process development. If applicable, this characterization is performed according to international pharmacopoeia.

ARTES provides to the client the full set of documentation necessary to transfer the process to his manufacturing site or to a CMO. Product samples generated and arms-length assistance in the transfer of the process developed are added to our offer.

cGMP compliant method development and routine analyses can be contracted with ARTES as well and will be provided in close collaboration with our industrial partners.

Large scale manufacturing (nonGMP and cGMP) can be contracted as well and will be performed at ARTES or at our partner facilities.

ARTES´ offer includes:

  • fermentation process development
  • downstream process development
  • in-process and quality control assay development

Manufacturing

Technical experts are involved right from the start of the project and remain involved during process transfer and production. This ensures a smooth transition from the project’s early phase up to commercial scale.

ARTES‘ offer includes:
  • optimizing and upscaling of fermentation and downstream processes
  • non-GMP manufacturing of test and pre-clinical material
  • cGMP manufacturing
  • quality control
  • transfer of analytical methods
  • transfer of documentation
  • professional project management

Technology Transfer

A range of bio-similar and recombinant protein products and processes is available at ARTES for out-licensing and technology transfer. With trainings or on-site support we assist our clients to implement the processes in their own labs respectively plants.

We transfer licenses on our intellectual property (IP) and know-how, on cell lines and on our developed processes.

For out-licensing we mutually agree with our partner on the terms and conditions in a case by case business model: non-exclusive or exclusive, regional or global licenses, lump-sum payments or milestone based payments.

Together with our client we find out the most efficient model.

Contact

ARTES Biotechnology GmbH
Elisabeth-Selbert-Str. 9
40764 Langenfeld

P: +49 (0) 2173 27587–0
F: +49 (0) 2173 27587–77

E: info (at) artes-biotechnology.com