Industry Insights
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Time To Scratch The “30-Year Itch” From MSCs’ Questions
11/1/2022
Explore some of the questions and theories behind why, after compelling pre-clinical and human safety data, MSC therapeutics are not progressing faster.
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Understanding The 5 Elements Of cGMP
cGMP outlines safety procedures for every basic part of production – defining what needs to be done to keep products safe, operate machinery properly, validate processes, and maintain consistent procedures.
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Insulin Under The BPCIA: Opportunities And Obstacles
4/22/2020
As of March 23, 2020, insulin now falls under the Biologics Price Competition and Innovation Act of 2009 (BPCIA). This regulatory shift presents both new opportunities and new obstacles for developers of follow-on insulin products.
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Key Considerations In Early-Stage Biopharma Financing
5/11/2022
After over two years of soaring IPO valuations and high stock prices, biotech had a reckoning in the back half of 2021. But while the industry is clearly facing headwinds, there’s significant cause for optimism for early-stage biotechs looking for funding, not the least of which is 2021’s high levels of venture capital fund formation.
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Biosimilars Pipeline Analysis: Many Products, More Competition Coming
7/26/2016
Our discussion of biosimilars in this article will center on developed-market GMP biosimilars. In the European market alone, biosimilars already are a multibillion-dollar business, and one that is rapidly growing.
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Congressional Bill Supports Advanced And Continuous Manufacturing
1/5/2022
The House recently passed H.R. 4369, which authorizes $100 million over four years to establish National Centers of Excellence in Advanced and Continuous Manufacturing at U.S. academic institutions. This article delves into the news and how it fits into other U.S. initiatives supporting the field.
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Single-Use, Stainless Steel, Or Both? Key Points To Consider
9/13/2023
Mass-producing cutting-edge, novel therapeutics is complex. First, companies must choose between single-use materials, stainless steel equipment, or a flexible solution that includes both elements.
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SARS-CoV-2: Massey Univ. Profs Develop Method To Quickly Sequence Genome
8/13/2021
It was a matter of time before the world saw variants emerge that increased the transmission rate of COVID-19. A research team led by two of these authors at Massey University have developed a new next-generation sequencing method for the ultrafast sequencing of the SARS-CoV-2 genome, which cuts the sequencing time by more than half.
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Achieving Integrated Quality Through A Continued Process Verification Program
11/1/2019
Continued process verification (CPV) is not only required for companies but also is a good investment in product quality and setting the foundation for continuous improvement.
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Strategies For Commercial Success In The Global Biosimilar Market
8/17/2017
we reached out to biosimilar experts from several prominent management consulting firms to ask for their perspectives on these archetypes, emerging biosimilar development and business strategies (as well as mistakes to avoid), and the market’s future.