Newsletter | July 31, 2019

07.31.19 -- The New Outsourcers: Amylyx And The Next-Gen Biotechs

  Biologic Drug Product Contract Manufacturer Quality Benchmarking (2nd Edition)

This market research report provides pharmaceutical companies and contract manufacturers with a comprehensive analysis of current outsourcing trends and practices in addition to a quantitative analysis of CMO service quality across a series of 23 performance attributes specific to drug product manufacturing projects. ISR presents data on 398 service encounters from 138 respondents who have been involved in outsourced drug product projects in the past 18 months. More.

From The Editor
The New Outsourcers: Amylyx And The Next-Gen Biotechs
By Louis Garguilo, Chief Editor, Outsourced Pharma

Justin Klee and Joshua Cohen were just 21 and 22 when they co-founded Amylyx Pharmaceuticals in 2013, while pursuing undergraduate degrees at Brown University. Today, their insights about drug development and manufacturing outsourcing are nothing short of remarkable.

Featured Editorial
Off-Site Modular Fabrication Of Biopharma Facilities: What You Need To Know
By Hector M. Samper, principal and strategic advisor, Global Strategic Sourcing Solutions (GSSS)

Measurable benefits of off-site module construction are becoming more evident, and it is emerging as a viable method for delivering a greater degree of predictability. Furthermore, market constraints driven by shortages of craft labor, lagging productivity, project complexity, and competitive forces are contributing to biopharma’s move toward modularization.

Maintenance 4.0: The Next Revolution In Bio/Pharma Manufacturing
By Tobias Kuners of Koenders, managing consultant, Tob Management

The next stage in maintenance management, Maintenance 4.0, is to go beyond predictive to the initial stage of an asset — commissioning the assets and deploying the same tools and techniques to set the measures within the design specification from the beginning onward, and using indicative measures to keep the asset in its original design specification.

Industry Insights
How To Transfer Cell-Based Potency Assays Into A GMP Environment And Maintain Performance
Article | By Aryo Nikopour and Ming Li, Ph.D., Nitto Avecia Pharma Services

Cell-based potency assays don’t travel well. Here’s how to make their trip more pleasant from a non-GMP lab to a GMP environment.

A Common Sense Approach To Sustainability In The Biosimilar Business
White Paper | By Ashok Kumar, president, Centre for Research & Development, IPCA

Through common sense and creative thinking, the industry can discover new ways to achieve success and sustainability in the biosimilar market.

Cold Chain Qualification: 5 Questions You Must Ask When Shipping Biologics
White Paper | Thermo Fisher Scientific

Organizations recognize the growing need for control of the entire cold chain as the changing global scenario requires highly efficient processes and flexibility.

The Challenges Of Biopharmaceutical Quality
Q&A | Samsung BioLogics

More than ever, the quality functions in biopharma manufacturing are under pressure. That pressure is unlikely to be relieved any time soon due to a global market rife with complex quality standards.

Standing Out In The Crowded Biopharma CDMO Market
Webinar | ISR Reports

When CDMOs understand what motivates drug innovators to outsource, who is involved in the service provider selection decision, and which CDMO attributes have the greatest influence on CDMO selection, they are able to communicate what is unique about their offering to the right audience at the right time. 

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