INSIGHTS ON FACILITY DESIGN
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The Impact Of Annex 1 (2022) On Sterility Assurance
Airflow visualization studies, crucial for GMP compliance, validate unidirectional airflow effectiveness in contamination control. Discover their enhanced role in quality by design and revised Annex 1 guidelines.
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Why Internal Manufacturing Is Key To Meira GTx's Success
CEO Zandy Forbes shared Meira’s origin story and how building an in-house manufacturing facility allows the company to develop an expansive pipeline of gene therapies.
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Process Analytical Technology In The ADC Bioconjugation Process
Integrating Process Analytical Technology into validated GMP processes is complex and costly, which requires thorough validation of equipment and cleaning methods. Explore more about PAT's role in ADC production.
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Overcoming Facility Constraints Posed By Process Intensification
Discover how your facility's layout and process flow might limit its potential and learn about media requirements in USP and DSP to optimize your scheduling and footprint for efficient media management.
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An Unrivaled Modular Seed Train For Process Intensification4/14/2025
Listen to experts as they discover a modular, perfusion-enabled seed train system and learn about the time benefits, cost benefits, and scalable process development for various production needs.
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Selecting A Platform Filter For High Concentration mAbs4/9/2025
Read more about how Fujifilm Diosynth Biotechnologies evaluated a prime filter with challenging simulant solutions and how the experimental data confirmed superior performance, which demonstrated twice the throughput.
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Implementation Of Multi-Column Chromatography Systems4/4/2025
Discover how a multi-column chromatography system enhances resin utility and enables continuous bioprocessing with minimal surge tankage for agile multi-product facilities.
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Meeting Demand For Enhanced Cleaning Protocols While Reducing Bioburden3/31/2025
Intensified cleaning protocols are vital for drug purity, yet strain conventional protein A resins. Discover how a novel resin, engineered for robust caustic resistance, ensures longevity and efficiency gains.
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Do Not Bear Cross Contamination In The Pharmaceutical Industry – Prevent It3/25/2025
Learn how thorough cleaning and process optimization in pharma manufacturing prevent cross-contamination, ensure product integrity, and enhance efficiency while also improving compliance and reducing costs.
FACILITY DESIGN SOLUTIONS
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Effectively managing maintenance for bioprocessing systems is challenging. Discover hardware that offers durability and proactive strategies that are essential to mitigate wear and optimize performance.
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Discover a service that offers access to certified engineers for training on system use and maintenance to ensure quality results, reliability, and productivity while reducing costs and extending equipment lifespan.
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Ensure GMP compliance for your bioproduction systems by investing in an extended warranty for optimal performance, high product quality, and effective cost management throughout your system's life cycle.
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Ensure your equipment meets stringent regulatory expectations with an instrument qualification service that supports you through installation, maintenance, and modifications for compliance.
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Regulatory bodies set clear expectations for cGMP environments. Discover how to simplify periodic reviews with robust mechanisms and advanced tools to ensure compliance and readiness for audits.