GERMANY – Rentschler Biopharma SE, a global contract development and manufacturing organization (CDMO) for biopharmaceuticals, and XL-protein, a privately held biopharmaceutical company in Germany, have formed a partnership to develop a long-acting, hyperactive recombinant human deoxyribonuclease I (DNase I).

The new innovation utilized Rentschler Biopharma’s expertise in bioprocess development expertise and XL- protein proprietary’s PASylation technology to develop a modified DNase I with significantly increased activity and extended pharmacokinetic profile.

Thilo Grob, vice president Process Science at Rentschler Biopharma SE, commenting on this development said: “This highly successful collaboration was due to Rentschler Biopharma’s strong expertise along the entire biopharmaceutical value chain ranging from cell line development, upstream and downstream processes to drug substance manufacturing in combination with XL-protein’s know-how and longstanding experience in the design of proteins with enhanced stability using its proprietary PASylation technology. The strong results from this case study pave the way for high yield manufacturing of other PASylated proteins and peptide drugs using mammalian cell culture on Rentschler Biopharma’s bioprocessing platform.”

While Dr. Michaela Gebauer, co-managing director at XL-protein, commented, “PASylation technology is compatible with efficient production in diverse expression hosts, and we now have shown that it can be applied to Rentschler Biopharma’s robust high titer mammalian cell line development platform which also allows for native post-translational modification of recombinant human proteins. This success further demonstrates the strength and flexibility of our technology platform and its potential to support biopharmaceutical partners seeking to develop recombinant protein or peptide drugs with extended half-life and low immunogenicity.”

Therapeutic DNase I has been used to treat cystic fibrosis for over 20 years and has the potential to be a promising treatment option for chronic as well as autoimmune or inflammatory diseases.

However, due to the short half-life of conventional DNase I, high dosing frequency is required, which may result in low patient compliance and, in the case of cystic fibrosis, an increased risk of lung infections.

Rentschler Biopharma and XL-protein collaborated to develop an improved DNase I that demonstrated both extended systemic half-life and increased enzymatic activity in an animal model.

While its DNA-degrading activity is associated with a burden for the producing cell line, the bioprocess’s high titer of recombinant protein is a remarkable success.

The clinical application of this PASylated hyperactive DNase I hold the potential to improve patient adherence and quality of life.

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