Biosimilar Manufacturing solution center
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SUS, PAT, And Other Tech Advancing Upstream Bioprocessing
4/26/2024
As the sector grows, technology and techniques are becoming more sophisticated, including single-use systems, automation, and bioreactors.
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Bulk Filling Of Drug Substance | Accurate Aliquoting
4/24/2024
Bulk filling drug substances in traditional facilities is often a lengthy, manual process where operators are relied upon to adjust pump controls to achieve accurate filling. This method, spanning multiple shifts, increases process risk through errors that can compromise accuracy.
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5 Areas To Focus Your QRM Strategy - Sterile Drug Products
4/24/2024
Explore five areas that can form part of a quality risk management strategy to ensure the compliant manufacturing of sterile drug products
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GMP Plant Uniform Lockers And Procedures: Best Practices
4/22/2024
As the use of GMP plant uniforms has gained acceptance, locker room layouts have arisen across companies and sites. This article examines alternatives and optimized approaches.
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What Time Is Best To Bring My CDMO On Board?
4/17/2024
The answer might be sooner than you think and entail more transparency than you're used to.
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Single Use In Biopharma: Beyond Savings & Sustainability
4/17/2024
SUT continues to trend in biopharmaceutical applications, driven largely by environmental and economic considerations. But there’s a lot more to the SUT story, including supply chain and standardization advantages. On April 24 at 11 AM ET, we’re diving into it live with independent SUT expert Paul Priebe and Krystal Biotech VP of Technical Operations Mark Petrich.
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Tips For Viral Vector Production
4/16/2024
Learn about how meticulous purification optimization can maximize recovery and impurity removal by leveraging scalable downstream technologies to meet regulatory and process economy requirements.
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What Is A Viral Vector?
4/16/2024
Review a novel adenovirus production process that offers scalable, single-use equipment-compatible solutions, reducing production time and cross-contamination risks.
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Simplifying CHO Cell Line Genetic Stability Testing
4/11/2024
Here, we describe the use of whole genome sequencing to perform a comprehensive assessment of genetic stability in clonally derived CHO cell banks using the Aptegra™ CHO genetic stability assay.
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A Single, Comprehensive Method For Genetic Stability Testing
4/11/2024
Discover a genetic stability assay that is fully validated to GMP quality standards and outperforms traditional testing methods with its enhanced speed and accuracy.