Month: April 2017

Addressing Buffer Bottlenecks using automated In-line conditioning and ready-made stock solutions for mAb processes

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Automation both saves time and minimizes the error risk with manual buffer preparation, ensuring consistency between batches. The built-in dynamic control functionality assures the accuracy of the buffers produced. In addition, using ready-made, highly concentrated, low-volume stock solutions, further increases efficiency by saving time and space in buffer preparation and minimizing the need for raw material qualification.

FDA CDER Novel Biologic Drug Approvals 2016

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The FDA released its report titled “Novel New Drugs 2016 Summary,” in which they discuss 2016 FDA new drug approvals. In 2016, the FDA’s Center for Drug Evaluation and Research (CDER) approved 22 novel new medicines. The number of approvals in 2016 was down from 2015 with 45 approvals and down from 2014 with 41 approvals. In fact, in looking at approvals over the past five years, 2016 had the lowest number of approvals overall, however the number of new drug filings remained consistent.

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