Industry Insights
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Wish SUS Cost Less? Survey Says Your Peers Do, Too
9/6/2024
BioPlan Associates 21st Annual Report found biopharma companies want lower cost single-use system options over any other new product development area.
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Six Serialization Mistakes Pharmaceutical Companies Make
12/21/2020
This article examines mistakes that are commonly made in the planning and implementation phases of a serialization project and proposes a solution to avoid each of these issues.
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What's The Role Of Intuition When Making QRM Decisions?
2/28/2022
In Part 1 of this 2-part series, this author explained how to effectively set up your quality risk management (QRM) program for pharma and medical devices. In this article, he explains how to implement that program. For such a numbers-based field, there is still an important role for using your intuition to make QRM decisions.
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A 5-Factor Framework For Successful CMO Partnership
10/31/2024
Identifying manufacturing capacity that can adapt to a growing and changing biopharma landscape requires an emphasis on technical and operational expertise combined with agility and flexibility.
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Statistics Abuse In QA/QC: 3 Lessons Learned
3/3/2021
One of the best tools at our disposal in a quality assurance/quality control context (manufacturing, supplier quality, etc.) is statistics. However, you should use caution and be mindful that you use it correctly and effectively. Eric Hinrichs, retired from Ethicon, Johnson & Johnson, shares his 3 lessons learned.
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Trends In FDA FY2022 Inspection-Based Warning Letters
2/21/2023
We analyzed the warning letters that the FDA issued to pharmaceutical and biotech companies in FY2022. Several key trends emerged, including a heightened scrutiny on two product types.
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Using AI In Drug Discovery Isn't The Golden Solution You Think It Is — Yet.
7/17/2023
Before we realize the true potential of advanced artificial intelligence (AI) and machine learning (ML) technologies to treat disease, we need to start by developing technologies that can generate the massive amounts of reliable, high-quality biological data that make up the fundamentals of any AI/ML approach.
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Pursuing Venture Philanthropy With Opus Genetics: The Business Of Biotech
8/10/2022
Explore new, more agile approaches to overcoming the advanced therapy obstacles inherent to bringing rare disease treatments to market.
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Experimental CCI — Induced Neuropathic Pain Model
6/18/2025
Advance neuropathic pain research and therapeutic development with the Chronic Constriction Injury (CCI)-induced neuropathic pain model to uncover mechanisms and evaluate promising candidates.
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Clarifying Confusion In Quality Assurance, Control, And Management Systems
3/24/2022
With similar-sounding terminologies, it’s easy to misinterpret their definitions and purposes. Here we demystify the roles of each quality function, ways they differ, and impact on one another.