BIO From The Editor and Guest Columns
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Bacterial Endotoxin Testing, Part 4: Key Tests For Endotoxin Detection
8/7/2024
This article concludes the author's series on bacterial endotoxin testing. It discusses best practices for the labeled lysate sensitivity test, non-interfering dilution determination, and more.
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Improving Viral Safety: Highlights Of ICH Q5A(R2), USP, Ph. Eur. Recommendations
8/6/2024
ICH Q5A (R2) was released in Nov. 2023 and adopted by the FDA and EMA earlier this year. For a fuller assessment of viral control, compendia from the USP and European Pharmacopeia help.
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DSCSA Implementation Is Progressing, But More Complexity May Be Coming
8/5/2024
The FDA recently announced it would exempt small dispensers from requirements of the Drug Supply Chain Security Act (DSCSA) until Nov. 27, 2026. The industry has made tremendous progress so far with DSCSA, but this discretion will make compliance more challenging.
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Rising Allure And Critical Considerations Of Point-Of-Care Processing
8/1/2024
Mobile and standard cleanroom infrastructures are becoming more popular to meet the logistical demands of personalized medicine and public health emergencies.
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Takeda Cut Its PPQ Timeline With beePFS — Here's How
7/31/2024
The company broke from the norm and used a layered approach — as opposed to a linear one — to develop a new filling line for prefilled syringes of IBS therapy Entyvio.
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Are Bioprocess Equipment Standards A One-Sided Conversation?
7/31/2024
Half of respondents to a recent survey of biopharmaceutical companies said the greatest challenge in further growing industry acceptance of single-use technology—which now comprises an eye-popping 85% of non-commercial-scale biopharma manufacturing infrastructure—is the greater challenge in further growing industry acceptance of single-use technology
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Integrating Analytics And Automation In Cell Therapy Manufacturing
7/31/2024
Experts from last month’s Cell & Gene Live event discuss practical ways to utilize emerging technologies.
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Draft Q&A Guidance Offers Roadmap For Biosimilar Post-approval Changes
7/31/2024
FDA explains how it's looking to evaluate the effects changes might have on biosimilar products' identity, strength, quality, purity, and potency.
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A Pragmatic 8-Step Approach To Choose Your Biologic CDMO
7/31/2024
Often, a CDMO partner is selected after a single recommendation or after being approached by a business development representative. There's a more pragmatic way to approach the process.
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The Real Cost Of Poor Quality — And What You Should Do About It
7/30/2024
It is well recognized that poor quality can lead to supply disruption. To drive positive change, the sector should seek to greater enhance quality maturity.