Industry Insights
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Manufacturing Of Viral Vectors For Gene Therapy
Viral vectors are essential for delivering corrected genetic information to faulty genes within affected cells and are at the heart of the gene therapy process.
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Overcoming Risk In Cell And Gene Production
9/20/2023
To meet the speed to market demands of today requires process standardization and portability, improvements in raw material supply and sourcing and greater supply chain control.
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4 Tips From The Experts: How To Tighten Your Timeline From Development To Trial
12/15/2020
Responsibly moving a cell or gene therapy forward as quickly as possible is a challenge associated with navigating a project’s development pipeline. Here are some general tips to assist you as your project moves from development to trial.
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Gap Analysis Fundamentals To Maintain Forward Progress
9/16/2020
Gap analysis—defined as the process of reviewing all the available information for a candidate product to assess current development status, identify potential gaps in information, and the subsequent steps required to develop a strategy to fill those gaps a fundamental and ongoing exercise. In a recent The Business Of Biotech podcast Dr. Valenzuela, CEO at Andes Biotechnologies, was joined on the podcast by Cristian Hernández-Cuevas, COO at Andes. Their collective reflections and advice on gap analysis execution provides real-world guidance for the leaders of emerging biopharma organizations.
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Retrofitting Facilities For Modern Bioprocessing And Pharma Production
3/11/2025
The U.K. National Health Service is developing a former warehouse into a multi-modal aseptic manufacturing hub. The project's production head talks pros, cons, and strategy.
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Scaling Up Your Methods with USP <621> - Part 3: Software
9/22/2023
Learn how Empower Software addresses modifications to certain calculations and maintains relevant naming conventions and calculations to help customers update SOPs to prevent disruption to operations.
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Biopharma Manufacturing For Advanced Therapies: A Panel Discussion
9/1/2023
Explore highlights from a panel discussion focused on improving biomanufacturing processes to help ensure the next generation of advanced therapies is both accessible and affordable to patients.
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Quintessential Role Of Apheresis In Gene-Modified T-Cell Therapy
6/20/2023
Learn more about process standardization and comprehensive quality management programs as it relates to leukapheresis and cell therapy manufacturers.
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What The Antibiotic Shortage Teaches Us About API Supply Disruptions
7/17/2020
The COVID-19 pandemic has highlighted the need to reevaluate API manufacturing partners, and we may see companies shift to a more regionally diverse supply chain, including an appropriate mix of localized and global capabilities to meet specific market needs.
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FDA Issues Guidance On Initiation Of Voluntary Recalls
4/5/2022
This guidance supports the requirements of 21 CFR Part 7 Enforcement Policy for drugs, medical devices, and biological products, and is being issued consistent with FDA's good guidance practices regulation. You may submit comments regarding this guidance to the agency at any time.