Latest Advances in the Stabilisation and Formulation 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 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

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.

Course Programme

Overview of Formulation Strategies and Principles

Physical Stability of Polypeptides

  • Conformational Instability
  • Colloidal Instability and Solubility Issues (including phase separation and opalescence)
  • Interfacial Instability

Recent Advances on the Chemical Instability of Peptides and Proteins

Protein Aggregation

  • Aggregation Kinetics
  • Mechanisms of Aggregation
  • Controlling Aggregation
  • Detailed Overview of Methods for Characterization and Quantitation of Aggregates

Rational Design of Protein Formulations

  • Frozen Formulations
  • Liquid Dosage Forms
  • Lyophilised Dosage Forms
  • Other Dried Dosage Forms

Strategies for Excipient Selection

  • Liquid Dosage Forms
  • Lyophilised Dosage Forms

Analytical Methods

  • Spectroscopic Methods (e.g., IR, CD, fluorescence, NMR, etc.)
  • Methods for Characterization of Lyophilised Powders
  • Methods for Monitoring Denaturation
  • Methods for Detecting and Quantifying Aggregation

Special Topics

  • High Concentration Formulations and Alternative Delivery Systems
  • Packaging of Biopharmaceuticals
  • Peptide Formulation Challenges
  • Stability Issues during Processing (purification, filtration, etc.)
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