Regenerative medicine holds promise, though evidence to back claims about current therapies is underwhelming. The FDA's announcement of the Tissue Reference Group Rapid Inquiry Program returns our attention to the administration's regenerative medicine policy framework.
By Ioanna-Maria Gerostathi, Mohammad Ovais, and Andrew Walsh
This article explores some of the typical issues that may be encountered during recovery studies and explains how the use of statistical tools for assessing recovery data can provide greater insight to guide decisions concerning recovery studies.
By Mark Snyder, Ph.D.,Bio-Rad Laboratories, Inc.
Whether these proteins are produced by recombinant DNA technology or extracted from sources such as plasma, they need to be highly purified — and the purification process must satisfy a variety of regulations.
Achieving consistent cell growth is critically important to the biotech industry. To optimize the final drug product output the current industry trends are toward higher cell densities and protein titers.
The failure rate for new drugs targeting central nervous system (CNS) diseases is higher than that of other diseases, both preclinically and clinically. This paper discusses some successful pharmacokinetic (PK) approaches employed in the recent past and may help in CNS targeted drug discovery and development efforts.
Consistent and repeatable batch operations are key to productivity in pharmaceutical and biotech processes. This white paper shows the importance of precision and repeatability, and describes how reliable, accurate instrumentation allows automation to support quality and productivity strategies.
Eppendorf invites you to be our guest at a complimentary bioprocess workshop where attendees will benefit as we present and discuss “Implementation of an Affordable and Scalable Manufacturing Strategy for Gene Therapy.” We will also present “A Beginner’s Guide to Bioprocess Modes – Batch, Fed-Batch, and Continuous Processing.”.
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