Industry Insights
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Comparability Considerations For mRNA Product Development
2/28/2024
Given the mRNA-based products' variability and unique challenges, you may need to modify the standard comparability approach. Let’s discuss strategies for any development stage.
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How Will New Trade Agreements Impact The Biopharma Industry?
11/7/2018
The Trump administration’s Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs highlighted foreign governments “freeriding” off of American investment in innovations.
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6 Simple Ways To Get Millennials (More) Invested In Quality
2/19/2018
Much has been written about millennials — how they think, what motivates them, and their outlook on life. How can we best prepare them for today’s pharma/biotech manufacturing environment so they are successful?
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Good Fences Make Good Neighbors: How To Build Strong CDMO Contracts
7/11/2017
Relationships between product companies and CDMOs based on clear, detailed, and comprehensive contracts have better outcomes than collaborations that rely on handshakes.
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ICH Final Q13 Guideline For Continuous Manufacturing: What It Means
12/16/2022
The International Council for Harmonisation released the final draft of its Q13 guideline for continuous manufacturing. It's yet another signal that global regulators see tremendous potential in CM. Here are the key takeaways.
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The Evolution Of Biomarker-driven Approaches To Clinical Trials
12/1/2020
Greater understanding of the specific and varying genetic bases for cancers has provided greater opportunities for clinical trials to take advantage of patient genetic variability for recruitment and segmentation purposes. In this article, historic data provide insights into the evolution and future of biomarker use in precision medicine.
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5 Important Takeaways From The FDA's Revised Quality Metrics Guidance
2/23/2017
On November 23, 2016, FDA published Submission of Quality Metrics Data, a draft guidance that addresses industry comments on an earlier draft guidance titled Request for Quality Metrics (2015). This article discusses the most significant differences between the two documents and what pharma manufacturers and CMOs should take away from these changes.
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Plasmid DNA Manufacturing To See Impressive Growth In Years Ahead
5/30/2023
Plasmid DNA is surging as an ideal starting material for gene therapies and vaccine production. Using new market research, let’s look at key market drivers, vital roadblocks, regional analysis, and the leading players in the space.
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How To Advance Continuous Bioprocessing Using Continuous Countercurrent Tangential Chromatography
8/30/2021
Continuous countercurrent tangential chromatography (CCTC) addresses the inherent limitations of column-based systems by conducting the chromatographic operations (binding, washing, elution, stripping, and regeneration) on a flowing slurry, with inline static mixers used to ensure good contacting between the resin slurry and the clarified cell culture fluid/required buffers.
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Cleaning, Sanitizing, Sterilizing, Or Wishing It Away: What Are We Doing To Control Bioburden?
4/12/2019
Bioburden is that dirty little topic nobody wants to talk about in mixed company (operations and QA) — a contamination that can get into our products at several entry points. Our fundamental responsibility is to eradicate it, but since it is invisible, we often make believe it doesn’t exist.