Downloads
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DEHP-Free CryoProtectâ„¢ Bio-Container
7/14/2025
Charter Medical’s DEHP-free CryoProtect™ Bio-Containers are designed for intermediate, final fill, storage, and transport in bioprocessing applications in bioprocessing applications using compatible freezing cassettes.
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Essential Steps For A Successful Analytical Tech Transfer
7/14/2025
Biologics tech transfer means sharing up to 20 assays. Miss a step, and you risk delays, bad data, and products stuck in limbo.
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A Guide To Accelerating Cell Line Development For Commercial Production
7/11/2025
Explore the challenges associated with cell line development in the production of biologics, and solutions that can help biotech developers evade the pitfalls of misinformed decision-making.
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Preparing For FDA's Expanded Use Of Unannounced Inspections At Foreign Manufacturing Facilities
7/10/2025
The FDA announced on May 6, 2025, that it intends to expand its use of unannounced inspections at foreign manufacturing facilities. Here are key considerations and actions to take in order to be prepared.
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Pharma Enterprise Resource Planning: From Automation To AI-Driven Insights
7/10/2025
Pharmaceutical firms are increasingly turning to enterprise resource planning (ERP) systems to modernize operations. These platforms unify core functions, including supply chain management, manufacturing, and financial planning and analysis.
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Managing Extractables And Leachables In HPAPI Manufacturing
7/10/2025
These contaminants can compromise the quality, stability, and safety of a drug product, and regulatory bodies mandate assessment to protect patients.
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Unlocking Value In Biopharma Operations: A C-Suite Call To Action
7/9/2025
Operational readiness will separate the leaders from the laggards, whether you lead a pharma/biotech innovator, CDMO, or a combination of both.
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Audit Trail Compliance And What To Look For In Mitigation Software
7/9/2025
In the pharma/biotech and medical device industries, the audit trail is important to have for accountability, data integrity, repeatability to create an event for investigation, and regulatory compliance.
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Best Practices For PUPSIT Assembly Design And Operation
7/9/2025
Navigate the complexities of PUPSIT with expert guidance. Discover best practices for assembly design, regulatory compliance, and troubleshooting common challenges in sterile filtration environments.
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Implementing Raman Spectroscopy For Automated Monitoring Of A Cell Culture Bioprocess
7/9/2025
Discover how Raman spectroscopy and parallel bioprocessing enable real-time cell culture monitoring, saving time and providing crucial data for process optimization in biopharmaceutical production.