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查看更多产品信息 Dynamis™ Medium - FAQs (A2661503, A2661502, A2661501)
12 个常见问题解答
CD FortiCHO 培养基已被证实在CHO生产，克隆形成和种子库建库等方面是一个性能优良的单次流加培养基。根据我们的经验，在 CD FortiCHO培养基中建立和筛选出的CHO克隆可直接转到Dynamis培养基中二无需适应过程。实际上，我们的工作提示这些细胞在 Dynamis 培养基中的生产能力与FortiCHO培养基一样好甚至更好，应用于工艺研发和放大生产时也与FortiCHO培养基同样稳定。
我们针对两类培养基开展的一些研究显示这两款产品具有类似的结果；当您的监管团队认为有必要从一款培养基换用另一款时，可将这一信息在机构中存档以支持您的工作。从技术转化至生产的过程中，如果您观察到效价没有改变，您所表达的蛋白的性状也有可能没有差异，可能仅需要做CMC更新或将补料程序进行微调。当然如果能够帮助您简化转换过程，我们的监管团队也很乐于与您的团队进行探讨。
当您使用不添加完全补料的流加培养进行生产时，我们建议您在需要时补充葡萄糖的培养条件下，维持不低于2 g/L的葡萄糖水平（参见更为详细的产品说明书）。我们发现EfficientFeed A+，B+和/或C+添加剂能够与Dynamis培养基配合良好，进而获得最大效价。我们推荐您优先试用1X和2X EfficientFeed C+，如果目的蛋白产率在培养后期下降，则可尝试添加Function Titer Enhancer产品。对于未使用EfficientFeed添加剂一类完全型添加剂培养的细胞而言，在细胞密度到达一半峰值之前无需添加任何添加剂。
当使用除Lonza的GS基因表达系统（GS Gene Expression System）的CHO细胞系时，推荐添加2-8 mM的L-谷氨酰胺或等量GlutaMAX添加剂。此外，我们建议您在必要时添加葡萄糖以维持不低于2 g/L的葡萄糖水平（参见更为详细的产品说明书）。
Dynamis培养基以干式AGT进行设计，比CD FortiCHO液体培养基更方便进行扩展。尽管两者在配方上有许多相似之处，其关键的差别在于使用了某些等摩尔的替代成份，以及少量添加了一些其他基础培养基中的组份。
Dynamis Medium contains glucose at a concentration of 6 g/L.
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While the full formulation for Dynamis Medium is proprietary information that cannot be disclosed, we can confirm that the medium contains a surfactant and that no additional surfactant would need to be added to the medium to support your suspension CHO cells in shake flask culture.
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CD FortiCHO medium has proven to be an excellent single-stream medium for CHO production clone development and banking. In our experience, CHO clones created and selected in CD FortiCHO medium can be put directly into Dynamis medium without any adaptation. In fact, our work suggests that those cells will produce as well or better in Dynamis medium and are just as stable in Dynamis medium if used for process development and scale-up.
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We have done some studies to show comparability of results between the two media, and that information may be filed with agencies in support of any work your Regulatory Team feels is necessary to establish transitioning from the one medium to the other. It is possible that characterization of your expressed protein after you see no other titer changes will be viewed no differently than a CMC update or minor modification to feeding profile during technical transfer to manufacturing. Of course our Regulatory Team would be happy to have a discussion with your team if it makes this transition any simpler for you.
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When culturing cells without complete feeds for fed-batch production, we recommend that you do not to allow glucose levels to fall below 2 g/L in culture by supplementing with glucose as needed (see product insert for more details). We have found that EfficientFeed A+, B+, and/or C+ supplements work well with Dynamis medium to maximize titers. We recommend trying EfficientFeed C+ 1X and 2X first, and if specific productivity drops off late in culture try the addition of FunctionMAX Titer Enhancer. No supplements should be added before reaching the day when half-peak cell density is reached for cultures not fed with complete feeding supplements like the EfficientFeed supplements.
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When using a CHO cell line other than Lonza's GS Gene Expression System, addition of 2-8 mM L-glutamine or similar amount of GlutaMAX Supplement is recommended. Additionally, we recommend that you do not allow glucose levels to fall below 2 g/L in culture by supplementing with glucose as needed (see product insert for more details).
Find additional tips, troubleshooting help, and resources within our Cell Culture Support Center.
Dynamis medium was designed to be more scalable in AGT dry format than CD FortiCHO liquid medium. Although there are many formulation similarities, the key differences are equimolar substitutions of alternate forms of some components as well as addition of a small amount of a component found in many other basal media.
Find additional tips, troubleshooting help, and resources within our Cell Culture Support Center.