Genetic Engineering & Biotechnology News

DEC 2017

Genetic Engineering & Biotechnology News (GEN) is the world's most widely read biotech publication. It provides the R&D community with critical information on the tools, technologies, and trends that drive the biotech industry.

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Angelo DePalma, Ph.D. If dealing with viral contamination seems like opening a can of worms, try not dealing with it. Yes, viral con- tamination occurs infrequently, but when it does occur, the consequences can be severe. Viral contamination incidents can shut down production facilities and inter- rupt drug supplies. Even before production commences, viral contami- nation demands attention. For example, failure to dem- onstrate virus removal during clinical programs can lead to costly delays in product approvals. Unfortunately, the viral safety of a drug cannot be adequately assured by simply testing the drug itself. As the FDA indicated in its 2012 Guidance, Q11 Develop- ment and Manufacture of Drug Substances, "with sterilized Viral Safety Copes with Complexity However, current 3D-printing technology is much more sophisticated. Applications for 3D printers range from rapid prototyping to food processing to consum- er products. Advances in 3D bioprinting have led to novel applications in surgery, personalized medicine, diagnostics, and drug discovery. The Bioprinting and 3D Printing in the Life Sciences Europe Conference in October 2017 gathered innovators in the 3D-printing space to share the latest advances in bioscience and medical applications—and we cover them here. Tablets On Demand 3D printing has the potential to transform a very familiar item—a tablet of medicine—into a bespoke medication tailored to an individual patient. Clive Roberts, Ph.D., professor of pharmaceutical nanotech- nology at University of Nottingham, U.K., wants to use 3D printing to transform the way clinicians pre- scribe some medicines. In his keynote presentation, "3D Printing Manufacture of Medicines," Dr. Roberts outlines a vision of a different kind of pharmacy op- erating around a 3D printer. "Imagine a circle where a clinician would interact with a patient, then decide what the personalized medicine requirements are for the patient. A computer model would work out the dosage and tablet structure required, and the 3D printer would make the tablet," said Dr. Roberts. The circle would be complete when the patient takes the medication and their re- sponse is used to adjust the see page 24 Catherine Shaffer Three-dimensional printing, also known as additive manufacturing, is a method of creating an object by precisely depositing material in layers according to the specifications of a computer model. Early 3D printers adapted conventional inkjet printer technology to create simple plastic objects. 3D-Bioprinting Conference Showcases Versatility December 2017 MALDI-MS Detection Schemes Hasten Drug Development 12 To Gild the Microbe Is Anything but Wasteful 14 Peptide-Based Delivery of Recombinant Proteins and Nucleic Acids 22 see page 18 Richard A. Stein, M.D., Ph.D. A key characteristic shared by all living cells is their abil- ity to communicate with other cells and with their en- vironment. This process, accomplished by intricate cell- cell and cell-signaling interaction networks, is critical during development, homeostasis, and disease patho- genesis. In recent years, learning about cell signaling has provided a better comprehension of cancer biology. At the same time, details about signaling in malignant cells have been critical for understanding cellular physiology. Targeted Therapies "One of our interests is to understand the detailed molecular mechanisms related to how dysregulation of the Akt signaling pathway contributes to different types of cancers," says Pengda Liu, Ph.D., assistant profes- sor of biochemistry and biophysics at the University of North Carolina–Chapel Hill. A major focus in Dr. Liu's laboratory is the identification of therapeutic targets that could modulate signaling in the PI3K-Akt pathway. This pathway is hyperactivated in virtually all the solid tumors that have been described. "But the mecha- nisms of activation are different from tumor to tumor," notes Dr. Liu. The PI3K-Akt pathway integrates extracellular sig- nals to regulate critical cellu- lar processes. Dysregulation Turning Cell Signaling against Cancer see page 8 Leading the Way in Life Science Technologies In 3D bioprinting, the inks consist of cells, biomaterials, and biological molecules, and the printouts are engineered tissues, which are built up, layer by layer, while retaining viability and, in some applications, the potential for integration with host tissues. Besides finding applications in regenerative medicine, 3D bioprinting is advancing organ-on-chip development, enhancing diagnostics and drug discovery.

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