Industry Insights
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How FDA, MHRA, & Russia's Drug Inspectorate Escalate Inspection Findings
10/21/2020
Representatives from the Russian Federation State Institute of Drugs and Good Practices, the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA), and the U.S. FDA share their processes for evaluating and escalating inspection findings to determine if regulatory action is needed.
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Round Tablet Compression Tooling — To Key Or Not To Key The Punches
7/30/2024
What makes the keying in tablet compression tooling, specifically in tablet punches, so important to the tablet manufacturing processes?
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Here's Why The Life Sciences Struggle To Exploit Process Knowledge
1/2/2025
Pharma often fails to take full advantage of the vast amounts of data it produces. It could do better with knowledge management embedded as a core business strategy.
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Beyond SOPs: Assessing Quality Of CDMOs
5/16/2024
When choosing a CDMO partner, it is essential to prioritize quality. Discover how the right partner can instill confidence in the safety and effectiveness of your pharmaceutical products.
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Holding The Supply Chain Accountable
3/11/2013
Quality is certainly not new terminology in the pharmaceutical industry. However, I believe it is a term that is sometimes used too loosely within the pharmaceutical time and temperature supply chain. By Jeff Clark, 7P Solutions™, LLC
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Is The Pharma Industry Really An Enemy?
10/15/2015
I consider myself to be a fan of the pharmaceutical industry. This is not simply because I write for a media group that covers the pharma industry. I feel like I was a fan even before taking on my current job. It may have started a few years ago when an ailment of old age (I’m 52) began to inconvenience me and disrupt my sleep. One little white pill taken once per day has now relieved me of that issue. So, while there are many industries that bring happiness and efficiencies into my life, only one of those industries has the potential to save the lives of patients with life threatening illnesses, and ease the suffering of others. That is the pharmaceutical industry.
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Cell Based Potency Assays: De-Risk Your Path With An Experienced CDMO
8/30/2024
Thorough characterization is key to unlocking the potential of antibody-based therapeutics. Leveraging a CDMO's extensive capabilities and expertise can allow you to navigate the biopharmaceutical development landscape.
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Bordering On Myth: Controlled Substances And The Canadian Border
12/9/2015
There is a common misconception that controlled substances won’t be allowed to cross the Canadian border, thus preventing some pharmaceutical products from being produced by Canadian contract manufacturing facilities. We need to move past this fallacy.
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Solutions For Mitigating Challenges In Recombinant Protein Production
5/13/2025
Through the use of advanced mitigation strategies, we optimize yield, enhance protein quality, and ensure functional integrity, helping clients achieve efficient and reliable recombinant protein production using E. coli systems.
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Oligonucleotide Manufacturing: Take Control Of Your Process
What do you need to know before you take your process in-house? A team of experts on nucleic acids therapeutics outlined five key things for you to consider as you make the change.