Biosimilar Manufacturing solution center
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How To Unlock Efficiency In MES Integrations
5/16/2024
This article outlines the significant benefits and framework for manufacturing execution system (MES) integration with systems such as enterprise resource planning.
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A Transient Cell Line To Produce rAAV With Low-Level hcDNA Encapsidation
5/10/2024
Discover the ability of a novel HEK293 suspension cell line for efficient and scalable rAAV production across various serotypes with low encapsidated host cell DNA levels.
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Review Of Applications And Processes In Fixed-Bed Bioreactors
5/6/2024
Gain insights and guidelines for developing new processes in this review evaluating publications on the applications of single-use, scalable fixed-bed bioreactors for adherent cell culture processes.
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Lentiviral Vector Production Using Single-Use Bioreactors
5/6/2024
Here, we outline a scalable and robust upstream process developed for LVV production of HEK293T cells and demonstrate how to expand HEK293T suspension cells.
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Nitrosamines: New WHO Guidance Provides Expanded Risk Assessment Considerations
5/6/2024
Nitrosamines are potential contaminants of drug products. Contamination can occur from synthesizing APIs and excipients, from leaching into the product from primary packaging, and more.
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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.