From The Editor
A Biotech’s Guide To Selecting CDMOs: “35 Or 6 To 2”
 
By Louis Garguilo, Chief Editor, Outsourced Pharma

As I spoke to Tom Bliss, veteran pharma and bio executive (e.g., Amgen, Baxter, Kyocera), and most recently CEO of platform-biotech Genisphere LLC,  I kept recalling Chicago’s iconic 70s rock song, “25 or 6 to 4.” That’s because Bliss was detailing how Genisphere went from a list of 35 or 6 candidate CDMOs to 2 selected as its development and manufacturing partners. 

Featured Editorial
New FDA Powers Under The SUPPORT Act: What Pharma Manufacturers Need To Know
 
By Cynthia Schnedar and Reva Alperson, Greenleaf Health

Drug manufacturers should be aware of new regulatory powers given to the FDA in a recently enacted law aimed at deterring opioid abuse. The Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (SUPPORT Act) became law on October 24, 2018, with bipartisan support in both the House and the Senate.

An Intro To Tools And Methodologies To Improve Change Management
By Peiyi Ko and Tom Schiavon
This first of a two-part article describes a change management model derived from the concept of co-creation, a process in which brands and consumers work together to create better ideas, products, and services. This first part discusses the tools and methodologies that provide a foundation for improving change management.
Industry Insights
Five Critical Mistakes To Avoid In API Development And Manufacturing
Article | By Raghavendar Rao Morthala, Ph.D., and Rajesh Shenoy, Ph.D., Piramal Pharma Solutions

In the rush to market, be aware of these critical missteps that can occur during the early development phases in order to avoid major challenges later during commercial API scale-up.

Characterizing Novel Microparticle-Encapsulated Drug Formulations
Article | By Trae Carroll, Singota Solutions

Once you have successfully encapsulated an API, the next task is to characterize that product and understand its release kinetics so that it can be labeled and prepared for subsequent studies. Following are some lessons learned from characterizing the end product.

Keys To Consistent Bioprocessing
Article | By Serena Fries Smith, Thermo Fisher Scientific

The development of a robust and consistent bioprocess requires a systematic and risk-based approach to identify the right process parameters and raw materials.

How Grünenthal’s Abuse-Deterrent Technology Combats Opioid Epidemic
Case Study | Patheon

While the wider use of opioids has led to many benefits for patients in pain, it also has led to higher incidences of misuse, abuse, and development of opioid addiction. 

Preparing For The Future: Visions And Insights For Biomanufacturing
E-Book | GE Healthcare Life Sciences

This e-book offers insights and advice from some of the industry’s top experts about current trends in biomanufacturing, modern process intensification techniques, and the outlook for digital automation. 

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