ProBioGen AG services
Process Development Services
You are looking for a robust manufacturing process for your antibody, enzyme or other glycoprotein that is reliably reproducible, scalable, and economical. You expect extraordinary productivity, efficiency and quality. Our upstream- and downstream process development delivers on that – and more. Having delivered a wide range of even demanding recombinant proteins, our team is looking forward to taking your product to new levels.
Virus Production Development Services
You want to overcome the historic way to manufacture viral vaccines on embryonated chicken eggs or on finite cultures of primary avian and mammalian origin. You want to avoid challenges in supply and scalability, variable performance, and increasing costs for source material and extensive safety testing. You are looking for a modern serum-free process avoiding traditional, technically demanding production which typically relies on roller flasks, cell trays or microcarriers. You want to focus on your vaccine instead of additional challenges like serum availability, costs and testing requirements.
GMP Manufacturing Services
Since 2002, clients from the United States, Europe and all over the world have trusted our Good Manufacturing Practice (GMP) to produce their antibodies and recombinant proteins for clinical use. Our goal is to grow with clients towards commercial manufacturing. Working in a competitive time-frame, we are committed to nothing less than your success. The long-standing experience of our expert team assures fast and reliable conversion of all development protocols into GMP-stage and the safe manufacturing of single or multiple batches. We offer our services both in-house and for externally developed processes. Your protein deserves the best platform in order to reach its full potential – we make sure it gets just that.
Creating Premium Biosimilars and Introducing Biobetters for Superior Results
Biologics have revolutionized the treatment of a number of severe diseases and thus given hope to countless patients. Your aim is to create a biosimilar that has the same properties as a successful biologic but is more affordable and hence available to even more patients. You need the process to be perfectly reliable for outstanding results and fast success. We can take you there. For more than 10 years, we have generated mammalian cell-derived biosimilars. Today, they are produced for the market and for clinical trials. Now, we can present an even further improved variant: our so-called biobetters.
Best-in-Class Quality Management Services
Customer satisfaction is at the heart of our quality management system (QMS), which assures products and services of utmost quality. We place the highest priority on product integrity, safe GMP manufacturing, and regulatory compliance (EMA, FDA, ICH). Our best-in-class QMS is founded on state-of-the-art technologies for manufacturing and testing. It is operated by a highly educated and continuously trained team of experts. All materials are sourced from stringently qualified suppliers. Certified quality is assured in every step of the process, from cell line development to scale-up and drug delivery.
High End Quality Control & Analytics Services
If you are developing a protein, you need it to perform exactly as intended. To make sure your protein is on track at all times, we have all the analytical methods ready. We apply physico-chemical analyses and activity assays throughout its entire development and manufacturing. No surprises means less time and cost.
GMP Production Cell Lines Services
Whatever the protein you wish to express, you need an optimal cell line, high yielding and stable. You are looking for an experienced specialist with a proven track record in developing cell lines even for challenging proteins – regulatory accepted, fast, reliable. You found it.
