ProBioGen AG is a specialist for mammalian and nonmammalian high-producer cell engineering and GMP manufacturing of biopharmaceuticals. Combining a deep molecular understanding of cells, scientific expertise, state-of-the art industry process engineering, and production know-how, ProBioGen is the partner of choice for biopharmaceutical companies seeking outstanding cell line development and manufacturing capabilities. Moreover, the company’s proprietary AGE1.cell linesĀ® are licensed to several key players in the industry and enable cost-efficient and safe production of vaccines and proteins.
ProBioGen has established a GMP unit based on disposable bioreactor technology, supporting all currently available manufacturing processes (stirred tank and wave in fed-batch and batch mode). The company possesses the manufacturing authorization from the competent authority and meets the quality standards of the EMEA and the FDA guidelines. ProBioGen is located in Berlin, Germany.
Products and Services
ProBioGen offers contract development and manufacturing services as well as access to its proprietary AGE1.cell linesĀ® for the production of antibodies, proteins, and vaccines.
An effective project management, combined with an open communication, makes ProBioGen a recognized partner for biopharmaceutical development companies. Providing a complete service spectrum from early development (including lead optimization) of high-producer cell lines to manufacturing of GMP material for clinical trials, ProBioGen serves as a true one-stop-shop. The company’s continuing innovations provide a range of individual solutions tailored to solve the most challenging problems and focus on increased yields and quality of biopharmaceuticals and vaccines. Our GMP experts accompany our customers closely and provide advice on all manufacturing aspects relevant to EMEA and FDA.
AGE 1Ā® Designer Cell Lines
AGE1.CRĀ®, ProBioGen’s duck cell line, has been developed in cooperation with IDT Biologika GmbH to replace embryonated chicken eggs and chicken embryonic fibroblasts as substrates for production of human and animal vaccines. This cell line supports the production of a wide spectrum of wild-type and recombinant viruses including highly attenuated poxviruses. No particle-associated retrovirus activity has been detected. Exhaustive analytical tests required for regulatory submission with US and European regulatory agencies have been performed and make the cell line extremely attractive for vaccines but also for proteins. The cell line is currently licensed to a number of pharmaceutical and biotechnology companies in a broad range of indications, proving its versatility and excellent manufacturing features. Access to the cell line is granted via feasibility studies, either performed at ProBioGen or at the potential licensee. Recently, Sanofi Pasteur accessed ProBioGen’s AGE1.CRĀ® cell lines for various products under development.
Cell Line Development
ProBioGen’s careful vector design, combined with the use of novel promoters, a sequential double selection strategy, specialized procedures for single cell cloning, as well as metabolic engineering enables the reproducible generation of highly productive and stable producer clones for batch, fed batch, and perfusion processes. Moreover, ProBioGen has established a broad spectrum of analytical methods, supporting the right choice of final clones for production processes.
ProBioGen’s fully documented CHO starter cell line has been selected for efficient growth in media free of animal components and for high growth rates at low cell densities with a minimal lag phase.
Contract Manufacturing
ProBioGen offers robust and rapid GMP and non-GMP production in fully disposable systems and in capacities up to 500 L. Services offered include
- Process development (upstream/downstream)
- Cell banking (WCB/MCB)
- GMP manufacturing
- Analytical services
A seamless transfer from our disposable single-use bioreactors to large scale manufacturing in stirred tanks is confirmed by a Strategic Production Alliance with Boehringer Ingelheim.
Bioassay Development and Human Artificial Lymph Node
ProBioGen offers supportive services such as cellular analytics and cell-based assays for product characterisation (potency and mode of action).
Immunogenicity and immune-functional testing can be performed using a proprietary in vitro model that emulates human immune organ function. Drawbacks in the pharmaceutical arena have raised significant concerns about the value of animal models. The tissue-based human Artificial Lymph Node (human ALN) technology defines the specific reactivity of individual human immune responses to antigens and enables to bridge the gap between animal studies and phase 1 clinical trials.
All testing services are provided to pharmaceutical and cosmeceutical development companies.