Under the Microscope: Latest Trends

With such a fast paced industry, it is sometimes hard to keep up with the most current trends in the industry. We asked a selection of the speakers here at the conference what they saw as the emerging trends in the industry; here is what they had to say.

 

Laurens Sierkstra, Thermo Fisher Scientific.

So, the biggest trends really are at all of the molecules so the bio therapeutics people are making are becoming a little more complicated than the standard monoclonal or standard single proteins which have been out there. So you see that as a trend towards things like gene therapy cell therapy antibody-drug conjugates people playing around with FC fusions and that sort of things. So right now, those changes are really there and happening in the field currently. Which again all need for some sort of manufacturing purification and downstream.

Parrish Galliher, GE Healthcare

Well this year and I think we have a number of trends in play. Certainly the trend towards single use technology with all the offerings that provides in terms of increased speed, agility, flexibility, reduced costs –that trend continues to strengthen around the industry and around the globe. And we predict going forward that because of those improvements, and those advantages that sings technology will continue to grow and penetrating the industry further in the future. We don’t think it’s a panacea for all manufacturing requirements, and applications but certainly it’s single-use continues to strengthen as a tool in our in our toolbox for manufacturing about pharmaceuticals.

Another trend that we see in this year strengthening is the interest in the evaluation of continuous manufacturing. As you know continuous manufacturing is not new to the industry and has been around since the beginning in various forms, and the number of drugs that are made continuously today and have been made that way for a number of years or decades in some cases. But with the advances of single-use technology making processes simpler, the complexity of continuous manufacturing is in fact reduced through the advent of single-use systems. And so installing and running continuously is easier and faster in single use technology, and that’s why we think that there is more attention being paid to continuous processing  in these recent years.

Going forward, the jury is out on whether continuous processing will dominate, or begin to take more of a role in the manufacture of drugs going forward market forces will determine that. Trends that are driving continuous manufacturing include not just the ease of single-use technology but the pursuit of smaller systems, more consistent manufacturing quality, the avoidance of having a scale up. So scaling out versus scaling up in those sorts of advantages. So in in in this in this particular trend the jury’s out as to whether or not continuous bioprocessing will be used for anything for any drugs that are really not unstable and in the reactors. Historically it’s been used for products that are not stable in the bioreactor.

Going forward the question is “will continuous manufacturing be chosen for drugs that are stable in the reactor? And which can be produced more efficiently via continuous processing?” So that question stands out there and we’ll see how it rolls out of the next five years but as I said it’s been around a long time I’ve been around 40 years and by processing and I’ve seen continuous processing come and go  three decades in a row and this is now the fourth decade will be interesting to see whether or not continuous by processing grows or passes.

Todd Przybycien, Professor Biomedical & Chemical Engineering Carnegie Mellon University

I work primarily in downstream processing and this actually is a really exciting time in downstream processing because we’re seeing a lot of possibility for innovation. I think the door was kind of opened a bit with the single use technologies that have come on board, and that has allowed folks to think a little bit more broadly about the kinds of operations they might introduce and downstream processing from non-chromatographic, or so-called alternative separation processes –Something that’s near and dear to my heart. And also continuous mode of operation it’s very exciting.

Daniel Galbraith, Sartorious Stedim BioOutsource Limited

So the biggest trends that we have are to try and tie together different types of analytical methods. So you might have a chemistry method like my spec and biology method like a cell-based assay and to try and understand how those two are really coming together with the analytics so we can explain one feature using another and we call that orthogonal methods.

 

 

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