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Genetic Engineering & Biotechnology News | GENengnews.com | AUGUST 2014 | 29 must completely rethink their documenta- tion and release criteria: How do they defne batches, what do they release, and where do they perform quality testing? I've asked several customers running perfusion cultures why they stop, and at what point they return to batch mode, and why. Invariably, they tell me they need a formal batch because regula- tors expect a certain volume that is quality checked before release. To achieve this with a continuous process is much more diffcult, if not impossible. The point of continuous processing is to gain effciencies not provided by batch operation. In that regard, very high den- sity cell culture, or even parallel cultures, could achieve the same result. Another avenue for efficiency, which I believe will roll out over the next fve years, is a higher level of automation and con- trol in single-use processing. Even hybrid manufacturing processes can beneft from greater utilization of sensors and controls. There will also be greater standardization of components and harmonization of pro- cedures and defnitions. All these improvements, which we hear so much about, will entail regulatory and tech- nical challenges. Industries like chemicals, foods, and beverages have for decades over- come these challenges, whereas biopharm is completely new to that degree of manufac- turing sophistication. GEN With the entrance of biosimilars, biobetters, personalized medicine, and the o-shoring of manufacturing, how will biopharmaceutical companies sustain themselves over the coming decades? Prof. Reif If I had the answer to this question, I'd be wealthy. The pull of biosimilars, par- ticularly from Asian manufacturers, will be tremendous. The question is how large bio- pharmaceutical companies will manage it. Installed and planned capacity for biosim- ilars is already huge, and growing. There will be so much pressure on branded versions of biosimilar drugs that even a fair number of biosimilars manufacturers may not survive. It has been said that prices will not fall as much for biosimilars as with small molecule generics, around 90%. Still, it is diffcult to imagine prices not spiraling downward as manufacturers engage in price wars. For that reason, the innovator company's only choic- es will be to continue to innovate and bring new and improved products to market, or lose their market position. A countervailing force will be governmen- tal support of biomanufacturing through f- nancial or tax incentives. At issue here is not only the availability of less-expensive bio- logicals for domestic consumption, but the strategic location of manufacturing. An especially sensitive location issue re- lates to vaccines manufacturing. Specifcally, it is desirable to have manufacturers within one's borders during a pandemic. Some Asian markets are, or will be, large enough to insist that biopharma distribute production into their countries. Companies in this situation will need to deal effciently with tech trans- fers, which can be risky for a variety of rea- sons outside countries of origin. Personalized medicine, where treatment relies on a drug and appropriate diagnostics is already here. Companies are already deal- ing with it. Personalized pharmacology will continue to improve based on new diagnos- tics arising from genome research. One pos- sibility might be combinatorial treatments based on prescreening. Personalized, cell-based therapies are an- other matter, as each patient will require a small "factory" for himself. Not to mention batch recording, release protocols, other reg- ulatory issues, and the resulting costs. Cell therapies might succeed in developed coun- tries with well-fnanced healthcare systems or if they adopt the orphan drug model, but then only if governments step in and subsi- dize these treatments. I do not see any indica- tion that they are willing to do so. Copyright © 2014 PerkinElmer, Inc. 400284_01 All rights reserved. PerkinElmer ® is a registered trademark of PerkinElmer, Inc. All other trademarks are the property of their respective owners. EnSight ™ Multimode Plate Reader WHEN MULTIMODE MEETS IMAGING YOU GAIN A WHOLE NEW PERSPECTIVE We call it "insightful science." It's about f nding new perspectives that increase certainty and conf dence in your results, improve biological understanding – and let you make bet er decisions sooner. Introducing the all-new EnSight™ system. It's a unique combination of multimode, label-free, and imaging technologies that come together as one, right on your benchtop – enabling a truly orthogonal approach to your research. T e EnSight system: See what insights your cells can reveal. www.perkinelmer.com/ensight Perspectives BIOPROCESSING