- Enabling services in the field of protein formulation represents one of LEUKOCARE`s key expertise.
- With our patented SPS® formulation technologies, deep understanding and broad know how, we pave the way for our customer´s products.
LEUKOCARE supports its partners with formulation development, related services and know how in order to implement the proprietary SPS® formulation technologies in the products of our partners.
LEUKOCARE is your partner for a successful protein and vaccine formulation development
Every biopharmaceutical is different and so is every pharmaceutical formulation. Thus, definition of relevant key factors prior to formulation development is critical. LEUKOCARE specifically identifies key factors for each project and elaborates applicable solutions meeting individual needs of our partners.
The following aspects are critical for a stable and successful protein formulation development:
Decision whether the formulation should be liquid or dry
- Liquid formulations are usually preferred and more convenient, dry formulations are generally more stable
- Decisions have to be strategic and should be based on the customer's target product profile (TPP) and the intrinsic stability of the protein
Definition of relevant stresses
- Physical stresses, e.g. heat, cold, freezing, irradiation, agitation, shear, surface and dehydration
- Chemical stresses, e.g. pH, active oxygen species and free radicals, metal ions and destabilizing impurities
Identifying major degradation products
- Physical degradation: aggregation, precipitation, denaturation and fragmentation
- Chemical degradation: oxidation, deamidation, disulfide scrambling, etc.
Choosing basic formulation parameters and key excipients
- Best combinations of pH, ionic strength and surfactants need to be identified
- Best performing formulations should contain the least number of necessary excipients
Applying meaningful stability indicating assays
- Appropriate analytical methods need to be defined to characterize stabilizing formulations
Considering IP related questions
- The use of certain formulations can be restricted by existing patents
- Freedom to operate (FTO) or options for licensing of existing formulations need to be considered
- Patented SPS® technologies can grant additional patent protection
We offer specialized analytical methods for the analysis of biopharmaceuticals and a successful formulation development.
Due to our quality management (QM) system according to EN ISO 13485, processes and methodologies developed by LEUKOCARE correspond to QM requirements of our partners.