A Two-Day Intensive Course with the Emphasis on Formulation and Dosage Form Design Strategies, Analytical Methods and Excipient Choices
Course Background and Objectives
To provide attendees with
- a solid understanding of the most common mechanisms of protein degradation;
- an overview of where pharmaceutical proteins are most likely to be damaged during bioprocessing and storage;
- the physical basis for the aggregation and solubility behaviour of polypeptides;
- descriptions of the most important analytical tools needed in formulation development, especially for aggregate quantitation and characterisation;
- an overview of the latest advances in protein formulation development;
- an appreciation of the importance of packaging in product performance;
- detailed strategies for stabilization of peptides as well as proteins.
In addition to lectures, the course will include individual and group exercises for evaluating the suitability of various formulations of pharmaceutial proteins
Key Benefits of Attending
Pharmaceutical macromolecules, whether proteins or peptides, are highly susceptible to degradation throughout the development process. From the time the active pharmaceutical ingredient is synthesized, it is subjected to stresses that can induce damage. For example, the processes of isolation, purification, formulation, packaging, and storage each provide opportunities for chemical and physical changes to occur with potentially disastrous consequences to the final product.
This course will provide a detailed overview of the common methods of degradation for proteins, as well as the most current strategies for stabilisation and formulation of pharmaceutical macromolecules. Emphasis will be placed on a mechanistic, rather than a phenomenological approach, towards stabilisation of peptides and proteins. Special emphasis will be given to the differences between peptides and proteins.
Who Should Attend
Anyone involved in the development of pharmaceutical macromolecules as commercial therapeutic agents, whether for human or veterinary use. This would include those involved in research & development, production, purification, formulation, manufacturing, and delivery of peptides and proteins. Those involved in overseeing these operations would benefit as well as those working at the bench. This course is intended for those currently working in the field and presumes a basic working knowledge of protein structure.
This course is intended for those currently working in the field and presumes a basic working knowledge of protein structure.
For more please download Latest Advances in the Stabilisation and Formulation of Protein and Peptide Drugs