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.
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.
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.
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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.
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.
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.
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.
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.