Newsletter | January 13, 2020

01.13.20 -- ISO 10993: Considerations For Drug Delivery Devices

Featured Editorial
ISO 10993: Considerations For Drug Delivery Devices
By Michael Song, Ph.D.

A host of factors come into play when evaluating biocompatibility, including how the medical device is sterilized, how the device is used, what body parts it makes contact with, and selecting testing approaches.

The Journey To Get An Ovarian Cancer T-Cell Therapy Into Clinical Trials
By Kevin Honeycutt and Erin Graham, Alliance for Cancer Gene Therapy (ACGT)

Daniel J. Powell Jr., Ph.D., along with his research team at the University of Pennsylvania, has launched a new clinical trial to treat ovarian cancer with a pioneering therapy involving genetically modified T cells. The trial, which has treated its first patient, almost didn’t happen.

Industry Insights
Scale Matters: A Flexible Approach To Demand Uncertainty
Article | By Bruce McCafferty and Mark Santos, Lonza Pharma & Biotech

Midvolume capacity bioreactors offer agility in an unpredictable industry and balance the cost of goods as a program prepares to launch.

Developing A New Biologic Drug: Regulatory Challenges And Considerations
Article | By Parrish Galliher and Brian Hubbard, GE Healthcare Life Sciences

The journey from research lab to market is a long one, and most drug candidates do not make it. For those that do progress to market there are many regulatory milestones and hurdles. Following are some tips to assist with up-front planning to prevent headaches down the road.

Strategies For API Solubility And Bioavailability Enhancement: Selecting Technologies And Excipients
Article | By Sanjay Konagurthu, Ph.D., and Tom Reynolds, Thermo Fisher Scientific

Bypassing conventional trial-and-error methods for solubility challenges and excipient selection can eliminate unnecessary testing, improve the efficacy of formulations, and increase overall speed-to-market.

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