Advanced therapy medicinal products (ATMPs) are booming, but ATMP formulations are still far from advanced: ATMPs either have a very short shelf life (hours to days) or require (ultra) cold storage conditions. A tailored formulation development program can remarkably improve this situation. Coriolis, an expert for biopharmaceutical research and (formulation) development, expands its ATMP development facilities to meet the increasing market demand.

Richter-Helm, a leading steadily growing Germany-based contract development and manufacturing organization (CDMO), offers excellent services in the continuously growing market of pharmaceutical biotechnology. Two additional bioreactors with capacities of 300 litres and 1,500 litres for microbial production will be added. This includes also the establishment of mid- and downstream processing and supporting utilities on a total area of about 10,000 m².

Innovators at Rentschler Biopharma are continuously developing new processes for biopharmaceutical production to tackle life-threatening diseases. Two of them, Dr Birgit Ehrenberg, Process Manager, and Monika Häußler, Quality Control (QC) Manager, shared insights into their latest projects and how close collaboration with chromatography experts from Tosoh Bioscience helped them develop robust, scalable, and economically viable downstream processes, as well as corresponding reliable bioanalytical methods.

With many complex factors affecting a therapeutic candidate’s chances of approval, partnering with a qualified service provider can be the most effective way to produce material for clinical trials. Outsourcing allows you to delay critical capacity decisions until the fate of your molecule is more certain but, how do you ensure this approach results in a successful process that’s delivered within your target timeline?