Introduction to the Formulation & Stabilisation of Protein and Peptide Drugs

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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

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.)

Mark Cornell Manning (Proteins and Peptide Drugs)

Dr. Manning is Chief Scientific Officer for Legacy BioDesign LLC in the USA Previously, he was Chief Technical Officer at HTD BioSystems. Before that he held a position as Associate Professor of Pharmaceutics at the University of Colorado School of Pharmacy. He received his B.A. in Chemistry from Hope College and his Ph.D. in Inorganic Chemistry from Northwestern University. After postdoctoral work at Colorado State University, he joined the Department of Pharmaceutical Chemistry at the University of Kansas as Assistant Professor. In 1990, he joined the faculty at the School of Pharmacy at the University of Colorado Health Sciences Center, where he was co-founder and co-director of the University of Colorado Center for Pharmaceutical Biotechnology (a joint enterprise between the schools of pharmacy and engineering). Dr. Manning is an affiliate faculty member in chemistry at Colorado State University and an adjoint faculty member at the University of Colorado. He has published over 100 scientific articles, received four US patents, and has co-edited three books in the series, Pharmaceutical Biotechnology. He has worked on a wide variety of formulation projects and drug delivery systems. His research interests include protein stabilization, drug delivery, and spectroscopy.

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.

‘Very nice informative course’

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