Biologics & Biosimilars
With more than 15 years of experience and numerous projects in biopharmaceutical formulation development, we have gained vast and extensive experience in the formulation of virtually all biologics compound classes.
- Bispecific antibodies
- Fusion proteins
- Plasma proteins
- RNAs, LNPs
- Various recombinant peptides and proteins
- High-concentration (e.g., for SC applications)
- Lyo to liquid switch
- Differentiated biosimilars
Case Study - 1 - MAb
Optimization of existing formulation for a clinical stage MAb
Customer project (inflammatory and fibrotic diseases). Key deliverable was the exchange of one specific excipient within the liquid formulation while retaining product stability and reducing aggregation.
Protein in liquid formulation during storage at 5 °C.
Case Study – 2
Reduction of viscosity and aggregation in a highly concentrated commercial antibody
Internal R&D project (oncology) on a to identify high concentration formulations with superior stability.
Dynamic viscosity of a commercially available antibody (200 mg/mL) in liquid formulation. By applying Leukocare technologies, the dynamic viscosity of the antibody could be reduced by 40%.
Aggregate formation of a commercially available antibody (200 mg/mL) in liquid formulation after 21 days at 30 °C. By applying Leukocare technologies, the aggregate formation of the antibody could be reduced by 97%.
Similarity to Originator
Significantly improved stability of Leukocare formulation (200 mg/ml) vs. Roche formulation (200 mg/ml).
High similarity between Leukocare formulation (200 mg/ml) and the marketed Roche product (120 mg/ml).
Due to highly similar monomer and aggregate content in accelerated ageing studies, the same shelf-life and end-of-shelf-life specifications at intended storage conditions can be expected.
Antibody monomer fraction (200 mg/ml) during storage at 25 °C.