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UGA Biopharma GmbH
UGA Biopharma GmbH is an experienced contract developer of biologics and biosimilars with the capabilities to handle all necessary steps from cell line development and bioprocess development to the development of purification strategies and appropriate analytics.
UGA Biopharma GmbH also offers its proprietary First CHOice® high-performance Chinese hamster ovary (CHO) cell culture medium and First CHOice® feeds to optimize the quality and product concentration of biologics and biosimilars.The First CHOice® medium and First CHOice® feeds were especially developed for CHO cells, but are not limited to CHO cells only.
In addition, UGA Biopharma GmbH offers to customers biosimilar expressing ready-to-use cell lines.
The company supplies its customers in Germany and abroad from its headquarter in Hennigsdorf, near Berlin. Several clients have used UGA products in clinical trials or have already received a marketing authorization.
Activities and Capabilities
UGA Biopharma GmbH CRO activities are centered on cell line development for biologics and biosimilars, specializing in the development of stable expressing CHO cell lines and cell media for the production of biologics and biosimilars for biopharmaceutical companies. Typical clients are biopharma manufacturers, research institutions (universities, research institutes, etc.) as well as start-ups and other CROs that need to outsource CLD, upstream, or downstream processing.
UGA’s mission is to fulfill customer requests, recognizing industry needs for high titer or fast delivery timelines, along with robust CHO cell lines. To this end, UGA can deliver high quality, and high titers, ranging from four to seven g/L, within four months of receiving the originator sequence.
UGA has also developed its proprietary First CHOice® cell culture media and feeds platform to boost the productivity of cell lines. Furthermore, UGA Biopharma GmbH offers ready-to-use biosimilar cell lines, which allow clients interested in biosimilar development fast track access to a highly biosimilar cell line.
Products & Services
UGA Biopharma GmbH offers products and services in three main categories:
- High speed cell line development service for biologics, biosimilars, new biological entities (NBEs) and mock cell lines, delivering fully data-supported cell lines, including molecular cloning, cell line and bioprocess development, DSP and analytics. Success is based on UGA’s well-established technology platform including high quality CHO host cell lines, optimized expression vectors and high performance media and feeds.
- Ready-to-use biosimilar cell lines for GMP manufacturing, including for example: Aflibercept, Adalimumab, Anakinra, Bevacizumab, Certolizumab, Ipilimumab, Nivolumab, Natalizumab, Pembrolizumab, and Pertuzumab. All available ready-to-use biosimilar cell lines are listed on UGA’s webpage under: http://www.ugabiopharma.com/ready_to_use_biosimilar_cell_lines/
- High performance First CHOice® medium and First CHOice® feeds to boost cell line productivity. These are chemically defined to eliminate BSE and TSE risks and optimized to biopharma production needs. First CHOice® cell culture media are specialized for CHO cells, but can be applied to other cell lines as well, still delivering significantly higher titers than alternative media.
Company history and structure
UGA Biopharma GmbH was founded in Hennigsdorf near Berlin in 2009. Dr. Lars Kober and Sylwia Naamane lead the company as CEO and CFO respectively.
In 2016, UGA launched its proprietary CHO DG44 cells and their proprietary expression plasmid, paving the way for the release of its First CHOice® medium in 2017 and the addition of First CHOice® Feeds in 2018.
In 2019, UGA Biopharma GmbH launched its CLD CHO DG44 platform, combining proprietary expression plasmids, CHO DG44 cells, First CHOice® medium and feeds.
The company currently has more than 35 employees.
Quality, Regulatory and Standards
UGA Biopharma GmbH strictly follows European Medicines Agency (EMA) regulation, EMA/410/01, relating to Animal Component Free Chemicals and Consumables.
Its internal quality management systems includes standard operating procedures (SOPs) covering all important and critical working steps, experiments and general rules.
UGA’s sound track record is proven in practice, with a number of customers having already gained market approval for manufacturing using UGA-developed cell lines.