Life Sciences

ProBioGen: expression technologies for therapeutic proteins

Biologics manufacturing technologies developer ProBioGen has established a number of new research and technology licensing agreements this year and, through a commercial agreement with Egyptian biotech company Minapharma Pharmaceuticals, has also established a new subsidiary, MiGenTra, to manufacture biopharmaceuticals for Middle Eastern and African markets.

Operational for 27 years and now employing more than 200 people at two locations in Berlin, Germany, ProBioGen is a specialist in the development and manufacturing of complex therapeutic proteins and has a number of proprietary technologies for protein expression, including its CHO.RiGHT expression platform and state-of-the-art process development platforms, together with intelligent and innovative product-specific technologies, all designed to yield biologics with optimized properties.

ProBioGen specializes in rapid and integrated cell line and process development supported by comprehensive analytical development and robust GMP manufacturing, with all of its services and technologies embedded in a total quality management system to assure compliance with international ISO and EMA/FDA GMP standards.

New technology agreements: Heat Biologics and LAVA Therapeutics

Recent developments at the company include establishing, in July, a research licence agreement with Heat Biologics for both ProBioGen’s Transposase System Directed Luck and the company’s proprietary suspension HEK293 cell line. DirectedLuck has been optimized to recognize specific epigenetic marks and guides the transgene to regions of highest transcriptional activity, ensuring high protein expression and maximal stability. The DirectedLuck Transposase is compatible with additional genetic elements in standard expression vector design and can be used with any host cell line. ProBioGen’s HEK293 has been optimized for the manufacture of proteins and viral vectors and is distinguished by robust growths in chemically defined medium in suspension culture, making it a valuable tool for production in large bioreactors.

In addition to its new agreement with Heat Biologics, in June this year ProBioGen and LAVA Therapeutics NV closed a second cell line development agreement to support a bispecific gamma-delta T cell engager (TCE) candidate in LAVA’s pipeline. Under the agreement and using its CHO.RiGHT expression platform, including its DirectedLuck Transposase technology for the generation of stable high-titre cell lines, ProBioGen will conduct cell line development of a novel gamma-delta bsTCE.

LAVA Therapeutics N.V. is a biotechnology company developing a portfolio of bispecific gamma-delta T cell engagers (gamma-delta bsTCEs) for the treatment of solid tumours and hematologic malignancies based on its proprietary platform using bispecific antibodies to activate Vγ9Vδ2 T cells upon binding to membrane-expressed tumour associated antigens with activated Vγ9Vδ2 T cells being engaged for direct tumour cell killing.

City of Hope commercial product agreement

Also in June of this year, ProBioGen established a commercial product licence agreement with City of Hope, a world-renowned independent research and treatment centre for cancer, diabetes and other life-threatening diseases, granting City of Hope the rights to use ProBioGen’s AGE1.CR.pIX cell line for manufacturing City of Hope’s COVID-19 vaccine candidate. ProBioGen says its innovative vaccine development platform is expected to be ideally suited for the production of large quantities of City of Hope’s synthetic MVA-based COVID-19 vaccine and that it will enable City of Hope and its commercial partners to manufacture the vaccine at scale for late-stage clinical development and eventually the market to address the urgent needs of the ongoing pandemic. The vaccine is currently being tested in a Phase 1 clinical trial, and was manufactured on City of Hope’s main campus within its Center for Biomedicine & Genetics, one of its three GMP manufacturing facilities.

ProBioGen’s duck suspension cell line AGE1.CR.pIX was designed to serve the industrial, GMP-compliant production of a wide variety of viruses in large bioreactors and has already been used for viral vector-based vaccine productions in various clinical trials.

Founded in 1913, City of Hope is a leader in bone marrow transplantation and immunotherapy including CAR T cell therapy, its translational research and personalized treatment protocols advancing health care with human synthetic insulin, monoclonal antibodies, and numerous breakthrough cancer drugs having been developed based on technology developed at the institution. The Translational Genomics Research Institute (TGen) became part of City of Hope in 2016, while AccessHope, a wholly owned subsidiary, dedicated to serving employers and their health care partners by providing access to the institution’s cancer expertise, was launched in 2019. City of Hope’s main campus is located near Los Angeles with additional locations throughout Southern California and in Arizona.

MiGenTra established as new subsidiary

Earlier this year, ProBioGen and Egyptian biotech company Minapharm Pharmaceuticals announced the incorporation of ProBioGen’s subsidiary MiGenTra with headquarters in Berlin and access to a site in Cairo, Egypt that will house its principal manufacturing plant. ProBioGen says the formation of MiGenTra accelerates its 2030 growth roadmap and emphasizes that further growth is not limited to the ongoing capacity increase but is one of several significant steps in the diversification of the company’s business.

MiGenTra will enhance accessibility to critical health care transforming medicines at affordable prices for patients in Egypt, the Middle East and Africa (MEA) while simultaneously strengthening regional and local manufacturing capacities. The company will respond to urgent unmet medical needs, supporting efforts by the World Health Organization (WHO) and the International Finance Corporation (IFC), and combines the scientific and manufacturing expertise from both contributing companies, ProBioGen and Minapharm Pharmaceuticals, MiGenTra now being fully established for product development and commercialization of biosimilars, cell and gene therapies (CGT) and vaccines.