First GMP Batch Launched – BIBITEC Produces Factor H for Eleva

We are currently producing Factor H, developed by our client Eleva (Freiburg im Breisgau), using their innovative moss-based cell line. After intensive preparation over the past weeks and months, all challenges have now been successfully overcome. The required production and qualification documents have been completed, and GMP manufacturing started as planned.

Cell thawing was successfully carried out in mid-July 2024. For our Upstream Processing (USP) team, this posed no obstacle – they were able to fully apply their experience and routine gained from four prior R&D batches and carry out all steps reliably.

Now, the next major phase is about to begin: Downstream Processing (DSP) is ready to purify the produced Factor H and prepare it for the next process steps.

At BIBITEC, we are proud to implement this project together with Eleva and to contribute to the development of novel biopharmaceutical therapies. At the same time, this first GMP production run demonstrates that our team, qualified facilities, and robust processes are well prepared to successfully handle complex cell culture projects under GMP conditions.

Our conclusion:
With the successful launch of this GMP batch, we are laying the foundation for many more to come in collaboration with Eleva – and we look forward to continuing to deliver innovative projects reliably and to the highest quality standards.