Project example: On the green path of moss - BIBITEC produces for eleva GmbH
At BIBITEC´s main concern in the years 2019 and 2020 was the green moss. On behalf of eleva GmbH (formerly Greenovation Biotech GmbH, Freiburg) a total of six 500 L processes were carried out for two different products. All processes were based on Eleva's platform technology for the cultivation of the spreading earth moss (lat. Physcomitrella patens) in illuminated production reactors.
After BIBITEC had already produced three GMP batches of alpha-galactosidase drug substance at 300 L scale for clinical phase I in 2016, a 500 L STR bioreactor (Sartorius, Germany) specially developed and illuminated for Eleva for the cultivation of moss cells was set up at BIBITEC´s facility in late 2019.
The technical commissioning by our USP team was based on a 500 L MOCK cultivation for the generation of host cell proteins (HCP). Concentrated by ultrafiltration, the culture supernatant was used to develop a moss-specific HCP ELISA.
In the same period, our experts have been working on the production of a Master Cell Bank (MCB) and Working Cell Bank (WCB) for the alpha-galactosidase expressing production strain. The GMP-compliant production of cell banks was a novelty for BIBITEC but is an appreciated extension of our services.
At the beginning of 2020 the complete alpha-galactosidase production process was transferred from Eleva to BIBITEC. Beside an adapted cultivation strategy this included the establishment of different analytical methods. In addition, an upscaling of the purification process from 300 L to 500 L was achieved by our DSP team within a short time. A specification-compliant production batch demonstrated the successful technology transfer. Therefore, a 500 L production process for the GMP-compliant production of alpha-galactosidase was established and is now available at BIBITEC for further clinical studies.
In mid 2020, BIBITEC started the development of the Factor H production process, a new pioneer project of Eleva. A total of four successful 500 L batches were performed to develop the cultivation process. In regular exchange with Eleva, BIBITEC has succeeded in establishing a potent process which clearly exceeded the expectations of the produced Factor H quantity. Part of process development was the testing and adaptation of different process and feeding strategies as well as the establishment of a suitable cell separation and concentration of the culture supernatant by ultrafiltration.
Published on 16.11.2020