Albumedix to host webinar on drug formulation15 Jun 2017
Albumedix will be hosting a webinar on recombinant human albumin for stabilization of difficult-to-stabilize biotherapeutics, titeled: When Standard Formulation Strategies Fail.
The webinar will take place on June 15th, 3PM London/10AM New York
To join, please register here:
Albumedix Science Director Phil Morton and Senior Scientist Eleonora Cerasoli will be hosting, taking audiences through important considerations in maximizing stability of biopharmaceuticals. This is not an easy task and therefore, a critical objective of any drug development program.
Learning objectives will include:
- Key Areas for Developability Risk Assessment
- Protein Aggregation and Chemical Stability
- Productivity and Yield
- Safety in Biopharmaceuticals: Immunogenicity and Immunotoxicology
Aggregation and depletion of proteins and peptides in drug formulations is a major source of dosage form and storage instability. The presence of aggregates and sub-visible particles also compromises the safety and efficacy of the drug formulations and may lead to a series of problems during manufacturing, handling and post administration. As such the minimization of protein aggregation and chemical degradation is part of a de-risking strategy key to ensuring a smoother “developability” of a biopharmaceutical.
Aggregation is a complex phenomenon and it can proceed via different mechanism. Depending on the rate determining step aggregates can be formed via association of partially unfolded conformers or by interaction of the proteins in their native state. Moreover, partial unfolding can be caused by diverse factors, for example it can be caused by interaction with interphases or following chemical degradation (e.g. Oxidation).
It is well-known that recombinant human serum albumin has the ability to stabilize proteins in solution preventing adsorption, aggregation and oxidation. The stabilizing ability stems from some of the roles albumin performs in blood, such as a carrier of small hydrophobic entities, participation in the control of pH and osmotic pressure and affording the majority of the antioxidant capabilities present in blood.
Recombinant Human Albumin (rAlb) is therefore a promising stabilizer for hard-to-formulate biopharmaceuticals. In this webinar we will illustrate the use of Albumedix™ Recombumin®, a recombinant albumin product, as a stabilizing agent for model biopharmaceuticals, both peptides and monoclonal antibodies (mAbs) at high concentration, and elucidate on potential mechanisms.
Formation of aggregates and sub-visible particles during product storage is a major concern for formulation scientists due to the potential for loss, reduced efficacy, and increased immunogenicity of the product. Therefore, optimizing the stability of a therapeutic drug during final drug formulation, handling and storage is imperative to producing a safe final product with an appropriate shelf-life.
Albumedix will in this webinar share from our 30 years’ of expertise within this area, in an aim to bring valuable yet initially unstable drug candidates to market and create better quality of life for patients and their families.
We look forward to your paticipation.