Bioproduction

One of the emerging new headaches for bioanalytical departments is aggregation, its impact on immunogenicity, stability and efficacy. I’d be interested to hear your thoughts on this phenomenon, what underpins its mechanism and what analytical techniques are being developed to counteract its effects. Please give us your thoughts so that we can pass them on to our expert panel who will be dealing with the topic at this year’s Bioproduction event.

New to this year’s Bioproduction is Protein Characterisation, a co-located event focusing on protein aggregation, impurities, glycan analysis and analytical strategies. As the conference producer I thought I’d give you an insight into some of the issues mentioned during my research.

Biopharma has a host of analytical tools at its disposal, from HPLC and Mass Spectrometry, to CE and AUC. However, no one technique is enough and companies must battle with the dilemma of choosing which technique to use, when and how to use it.

The main problem is that there is no real form of standardisation, with industry left with the unenviable task of filling in the blanks – and there are a lot of them. Like all successful business the key is in the planning – choosing which technologies to outsource or bring in-house, encouraging interactions between analytical and formulation departments from the start and validating methods in line with international regulations.

Analytical managers, like those at the very top, must formulate an strategy early on, decide which technologies are needed and invest appropriately. Then, once the data is generated, turn this information into tangible results that meet both commercial and scientific end-points.

This is why sharing information at events like Bioproduction is so important; understanding what techniques are working, what aren’t and where to focus your research.  I’d be very interested to hear your opinions on this and what you feel are the main bottlenecks and challenges impacting protein characterisation. I look forward to hearing your thoughts.

– Daniel Barry