Latest Advances in the Stabilisation and Formulation of Protein and Peptide Drugs

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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

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.)

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 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.


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