Wednesday, February 19, 2014

Planning Our New Protein Aggregation Event Brings a Change in Behavior

By Scott Wallask
Conference Producer, IBC Life Sciences

Last week, I stopped using drugs past their “expires by” date.

There. I said it – and in stating so, I also imply that I previously ingested expired meds.

To me, it wasn’t the same as maybe drinking milk that was a few days old. That latter practice is disgusting, often smelly, and can probably get you sick.

However, I honestly thought that a flu-fighting gel capsule could exist for years and years without worry, suspended in a state of frozen perpetuity until my nose and throat needed it. After all, medication isn’t food and it isn’t going to go sour on you.

Well, my attitude changed as I started researching a conference that has since become IBC’s newest drug discovery offering, Protein Aggregation, Stability & Solubility. The event takes place June 4-6, 2014, at the Grand Hyatt Hotel in downtown San Francisco.

In the midst of my calls to aggregation experts and research on the topic, I remember leaving work one night feeling unnerved about the end results of aggregation. In the case of protein therapeutics, aggregation can manifest as tiny particles that are either formed by some sort of chemical reaction within the formulation or perhaps by leaching of the surrounding materials into the solution. Sometimes this degradation can take years to occur, thus the expiration dates.

A few discussions with clinicians told me that aggregation can result in unintended immune responses in patients and consumers, otherwise known as immunogenicity concerns. Granted, there’s a long leap between a flu capsule and a cancer-fighting drug in terms of what aggregation can lead to, but the connection was crystal clear to me: Expired drugs might actually not be safe to use.

Imagine that possibility lurking in the back of a biotech researcher’s mind at the start of the long road to a protein drug’s development. The aggregation risks evolve as you enter the upstream and downstream phases. Does the protein you’ve chose bear a heightened threat of aggregation occurring? Will the excipient you add during formulation create aggregates later on?

The lesson I take from developing our Protein Aggregation, Stability & Solubility program is to measure for aggregation, and then measure again a different way. You’ll hear that theme a lot on our agenda, whether you tackle aggregation from the protein engineering side or through cutting-edge analytical methods.

Check out our current list of sessions and see what interests you. This is shaping up to be one of the largest aggregation-themed gatherings ever, with more than 30 sessions taking place over three days.

My job was easy – I just threw out my expired meds. Your job – preventing aggregation from occurring in the first place – is a lot tougher. I know the speakers and topics at our meeting in San Francisco will make your jobs a bit easier in that regard.

Follow Scott on Twitter @Scott_biopharma

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