Biosimilar Manufacturing solution center
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2024 Emerging Trends In Cleanroom Technologies
8/14/2024
This article shares new market research on pharma/biotech cleanroom technologies, including regional trends, prominent vendors in the space, and more.
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VR/XR In Drug Manufacturing: No Longer Sci-Fi
8/13/2024
Virtual reality (VR) immerses users in a completely simulated environment, while extended reality (XR) is an umbrella term encompassing VR, augmented reality, and mixed reality. These capabilities open up a world of possibilities for drug manufacturing.
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Report: Single-use Bioreactor Uptake Plateaued, Other SUT On The Rise
8/12/2024
BioPlan Associates' latest manufacturing survey found signs of a maturing market and strong demand for innovation upstream and downstream.
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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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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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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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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.
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Harnessing Analytics To Minimize Antibody Variants And Speed Up Development
7/30/2024
Antibody heterogeneity comes in many flavors — size and charge variants, and from post-translational changes. To control them, start with thorough characterization.