Newsletter | July 17, 2019

07.17.19 -- Ending Generic Drug Shortages At Hospitals: A Capitalist Goes Nonprofit

From The Editor
Ending Generic Drug Shortages At Hospitals: A Capitalist Goes Nonprofit
By Louis Garguilo, chief editor, Outsourced Pharma

I hope Outsourced Pharma readers will enjoy this editorial with Civica Rx President & CEO Martin VanTrieste, featured in this month’s issue of Life Science Leader magazine. VanTrieste has a business plan that could set the generics industry on a new path of full disclosure of drug-manufacture origin, and direct delivery to the point of patient use. Part 2 of this feature will be released next month, with a direct focus on CDMOs and Civica. 

Featured Editorial
An Analysis Of 2018 FDA Warning Letters Citing Data Integrity Failures
By Barbara Unger, Unger Consulting Inc.

FDA enforcement for failures in data integrity and data governance began almost 20 years ago, and these areas remain as enforcement initiatives of the FDA and other global health authorities to this day. In 2018, however, we may have turned a corner.

Equipment Change Control For GMP Production Facilities: How To Start
By Greg Weilersbacher, Eastlake Quality Consulting

While many may conceptually understand change control for equipment and facilities, most lack the knowledge to apply this control to highly sophisticated equipment and the utilities to which they connect.

Industry Insights
Addressing New Chromatography Challenges With Fiber Adsorbents
White Paper | By Iwan Roberts, GE Healthcare Life Sciences

A new adsorbent material using a novel proprietary structure overcomes the diffusional and flow limitations of packed bed chromatography purification systems and also aims to address the capacity issues of chromatography membranes.

It Depends: The Real Answer To The Single-Use Or Stainless Steel Question
Article | Samsung BioLogics

During the past decade there have been innumerable comparisons between stainless steel and single-use (SU) biomanufacturing systems. Anyone who has delved even slightly deep into the subject knows there isn’t a simple, clear-cut answer to which system is “best.” The reality is that stainless steel and SU can coexist — and often do in today’s hybrid bioprocessing manufacturing environments.

Comparing Continuous And Batch Processing In Downstream Purification
Case Study | Catalent

Current state-of-the-art continuous manufacturing technologies are being developed and implemented to manufacture a wide variety of products including monoclonal antibodies, recombinant proteins, and other biological modalities. Though upstream fed batch and perfusion bioreactors unit processes are relatively mature, downstream process unit operations are less mature. In this case study, Catalent compared the productivity of purifications running in batch versus continuous mode.

Managing Risks In The Development And Manufacture Of Potent Pharmaceuticals Products
Case Study | Pharmaceutics International

Given the variety of products currently in development, including potent drugs, outsourcing the development and manufacturing to a CDMO experienced in handling a range of products, in a multiuse facility, has proven to be an effective strategy.

Expanded Reach For Global Clinical Trials
E-Book | Fisher Clinical Services

Clinical trials increasingly include patient populations that span the globe. To meet the needs of trial sponsors, Fisher Clinical Services continues to expand by adding new facilities in emerging markets.

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