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2024 ISPE Biotechnology Conference
Jeff Heil shares his insights from the 2024 ISPE Biotechnology Conference, held in Boston, MA on June 17-18, 2024.
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Using Multivariate Data Analysis in Predictive Process Control
Understand the key advantages that multivariate data analysis MVDA provides over traditional univariate statistical techniques, which focus on monitoring one quality variable at a time and are not robust enough to analyze complex manufacturing processes effectively.
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Summary of FDA Guidance for Industry: Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products
On Jan 29th, 2024, the FDA released their Guidance for Industry on Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products. Read on as Aidan Harrington full summary on this guidance and what it means for the manufacturing of CAR T cell products.
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2024 ISPE Europe Annual Meeting
Emily Heffernan presented “Advances in Gene Editing and Impact on Facility Design" at the 2024 ISPE Europe Annual Meeting in Lisbon, Portugal. Read on for her insights.
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How Edge Computing Supports GMP Data Collection and Reporting
Edge computing will support GMP data collection and reporting due to the need to improve efficiencies and expand production to deliver more drug development and manufacturing services. This need results from the growing novel therapies market and the need to streamline operations to keep up with demand.
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Oligonucleotide Manufacturing Facility Design: Overcoming Unique Challenges
In the ever-evolving world of molecular biology and genetic research, oligonucleotides play a pivotal role in a vast array of applications, from DNA sequencing to gene synthesis and targeted therapy development. Designing oligonucleotide manufacturing facilities is a challenge since flexibility and future scalability need to be accounted for. However, the work is imperative to developing and distributing innovative therapies that can cure diseases previously thought of as uncurable.