Introduction to the Formulation & Stabilisation of Protein and Peptide Drugs

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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


Two-Day Short Course with the Emphasis on Formulation and Dosage Form Design Strategies, Mechanisms of Degradation and Excipient Choices

Course Background and Objectives

To provide attendees with:

  • A perspective on the importance of formulation development in the biopharmaceutical industry
  • An understanding of the most common mechanisms of protein degradation
  • An overview of where pharmaceutical macromolecules are most likely to be damaged during handling and storage
  • The physical basis for the aggregation and solubility behaviour of polypeptides
  • Descriptions of the most important analytical tools needed in formulation development
  • Detailed strategies for stabilization of peptide proteins and chemically modified proteins.

In addition to lectures, the course will include group exercises for evaluating the suitability of various formulations of pharmaceutical proteins

Who Should Attend?

Anyone involved in the development of pharmaceutical macromolecules as commercial therapeutic agents, whether for human or veterinary use. This course is intended for those new to the field and those who simply wish to obtain an overview of this important discipline. 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.

Course Programme

Overview of Formulation Development and Principles of Proteins Stabilisation

Introduction to Protein Structure and Physical Properties

Overview of Instability Issues with Proteins

  • Chemical Instability
  • Conformational Instability (unfolding)
  • Colloidal Instability
  • Interfacial Instability

Introduction to Protein Structure and Physical Properties

Protein Aggregation

  • Basic Aggregation Mechanisms
  • Controlling Aggregation
  • Quantifying Aggregation

Rational Development of Liquid Dosage Forms

  • Formulation Strategy
  • Excipient Selection
  • Selection of Analytical Methods

Rational Development of Dried Dosage Forms

  • Formulation Strategy
  • Excipient Selection
  • Selection of Analytical Methods

Special Topics

  • High Concentration Formulations
  • Chemically Modified Proteins (PEGylated proteins, antibody-drug conjugates, fusionproteins, etc.)

What people said about Introduction to the Formulation & Stabilisation of Protein and Peptide Drugs
'Very nice informative course'

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