The Workshop was kicked off by an excellent Plenary talk from Advait Badkar (Pfizer) who explained how protein aggregation has the potential to impact negatively on all steps of biopharmaceutical manufacture from upstream to fill-finish. This was followed by a stimulating presentation by Wim Jiskoot (University of Leiden) who discussed the types of protein aggregate that may be responsible for development of loss of immune tolerance within patients. Finally Graham McPherson (Avecia) expertly explained how protein aggregation could be monitored within vaccines and pointed out how for such products aggregation may actually provide benefits
The delegates then nucleated into teams in which they competed to best refold a denatured lecture on “Mechanisms of Protein Aggregation” in the limited time provided. Following this fierce competition (see picture) a more leisurely time was spent in the evening, networking at the Old Fire Station in Brentford.
The second session allowed the delegates to learn more about the analytical techniques that can be employed to investigate aggregation. Gillian Beaumont (Intertek) systematically discussed the advantages, disadvantages, uses and limitations of a wide variety of methods including more traditional chromatography and gel-based approaches through to not-as-well established methods such as field flow fractionation and dynamic light scattering. Ashok Garnesan (Xstalbio) discussed an alternative approach using protein-binding dyes and spectroscopic analytical methods. Anna Hills (NPL) ended the presentation section of the session discussing the role of her organisation in setting universal standards for the analysis of aggregation. The second interactive session led by Andrew Thomson (bioProcessUK) saw the break out groups decide on the most appropriate analytical techniques for a fictitious molecule that was showing significant aggregation based on analytical data that was given to them.
Session three focused on formulation and process strategies to reduce or potentially eliminate unwanted aggregation in therapeutic protein dosage forms. Rob Forbes (University of Bradford) provided insight in to commonly used excipients to reduce aggregation and highlighted the importance of primary packaging considerations. This was then complemented by a presentation by Faisal Uddin (Medimmune) which described approaches used by protein purification scientists to remove aggregates in the down stream processing of bulk drug substance. The session concluded with the final interactive session led by Kevin King (Pfizer). In this session, the delegates were challenged with applying what they had heard in the previous sessions and lectures to design a dosage form for a monoclonal antibody which was prone to aggregation.
The TBV Focus group would like to extend a special thanks to Ahmed Yasin from GSK who kindly facilitated the use of GSK House for this meeting.
Written by Kevin King (Pfizer), Barry Moore (University of Strathclyde) and Andrew Thomson (bioProcessUK).
For further information please contact Andrew Thomson or click here to visit the APSGB website.
Protein Aggregation Workshop Attendees
