01.30.19 -- 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. 

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.

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.

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.

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.

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

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. 

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. 

Nitto Avecia Pharma Services

Patheon

Think you have a good idea for an article that Outsourced Pharma readers would find valuable? Read these guidelines first before submitting your idea or your article to our editorial director. 

Have you heard of Life Science Leader?
Check it out today for access to candid interviews with top-tier executives on how they do business.