8 JULY - FDA will soon publish a Federal Register notice extending the period for public comment on how the agency's regulation of commercial speech can best safeguard public health while complying with First Amendment protections.
FDA will soon publish aFederal Register notice extending the period for public commenton how the agency's regulation of commercial speech can bestsafeguard public health while complying with First Amendmentprotections.http://www.fda.gov/bbs/topics/NEWS/2002/NEW00819.html
COMMENT PERIOD EXTENDED FOR PUBLIC DISCUSSION OF FDA AND 1ST AMENDMENT
8 JULY - FDA will soon publish a Federal Register notice extending the period for public comment on how the agency's regulation of commercial speech can best safeguard public health while complying with First Amendment protections.
FDA will soon publish aFederal Register notice extending the period for public commenton how the agency's regulation of commercial speech can bestsafeguard public health while complying with First Amendmentprotections.http://www.fda.gov/bbs/topics/NEWS/2002/NEW00819.html
REGENXBIO Releases Schedule of Its ASGCT Oral Sessions and Poster Exhibits
The company has had abstracts accepted for three oral presentations and five posters.
Mastering Antibody-Drug Conjugates
In this episode, we explore BIOVECTRA’s capabilities in antibody-drug conjugate (ADC) manufacturing, from complex conjugation chemistry to synthesis of highly potent payloads. We’ll also showcase how BIOVECTRA’s extensive experience in complex chemistries and specialized small molecule manufacturing gives them a unique perspective, strengthening their approach to ADC production and ensuring clients receive custom solutions across all project stages.
FDA Appoints New Director of CBER
Dr. Vinay Prasad, MD, MPH, a hematologist-oncologist, has been chosen to lead the Center for Biologics Evaluation and Research at FDA.
Bringing Scalability to Metabolic Flux Analysis using Machine Learning to Accelerate LC-MS Interpretation
Metabolic Flux Analysis (MFA) is a powerful technique used to characterize metabolic phenotype driving to improved productivity in biomanufacturing. MFA is most powerful when absolute concentrations of the metabolic intermediates are measured, but doing so in practice is often impractical due to inherent limitations of conventional absolute quantitation by mass spectral analysis. Recently, advances in artificial intelligence (AI) have been applied to solving the problem of broad, untargeted, absolute quantitation in liquid chromatography-mass spectrometry (LC-MS). These new approaches extend readily to the determination of absolute concentrations of stable isotopically-labeled metabolic intermediates, offering a new tool for MFA. Dr Sam Yenne from Metalytics Inc., a company that specializes in the science of metabolic flux, has recently assessed and adopted Pyxis, a new tool for absolute quantitation of raw LC-MS data. Dr Yenne describes MFA, its utility in biopharmaceutical development, associated challenges and how Pyxis impacts those challenges.
Automation Advances for Cell Harvesting in Biomanufacturing
Although automation is increasingly adopted in biomanufacturing, challenges remain in implementing it at the cell harvesting step.
Sustainability by Design in the Context of Bioprocess Development
Incorporating sustainable practices into process designs as early as possible ensures optimal performance.
REGENXBIO Releases Schedule of Its ASGCT Oral Sessions and Poster Exhibits
The company has had abstracts accepted for three oral presentations and five posters.
Mastering Antibody-Drug Conjugates
In this episode, we explore BIOVECTRA’s capabilities in antibody-drug conjugate (ADC) manufacturing, from complex conjugation chemistry to synthesis of highly potent payloads. We’ll also showcase how BIOVECTRA’s extensive experience in complex chemistries and specialized small molecule manufacturing gives them a unique perspective, strengthening their approach to ADC production and ensuring clients receive custom solutions across all project stages.
FDA Appoints New Director of CBER
Dr. Vinay Prasad, MD, MPH, a hematologist-oncologist, has been chosen to lead the Center for Biologics Evaluation and Research at FDA.
Bringing Scalability to Metabolic Flux Analysis using Machine Learning to Accelerate LC-MS Interpretation
Metabolic Flux Analysis (MFA) is a powerful technique used to characterize metabolic phenotype driving to improved productivity in biomanufacturing. MFA is most powerful when absolute concentrations of the metabolic intermediates are measured, but doing so in practice is often impractical due to inherent limitations of conventional absolute quantitation by mass spectral analysis. Recently, advances in artificial intelligence (AI) have been applied to solving the problem of broad, untargeted, absolute quantitation in liquid chromatography-mass spectrometry (LC-MS). These new approaches extend readily to the determination of absolute concentrations of stable isotopically-labeled metabolic intermediates, offering a new tool for MFA. Dr Sam Yenne from Metalytics Inc., a company that specializes in the science of metabolic flux, has recently assessed and adopted Pyxis, a new tool for absolute quantitation of raw LC-MS data. Dr Yenne describes MFA, its utility in biopharmaceutical development, associated challenges and how Pyxis impacts those challenges.
Automation Advances for Cell Harvesting in Biomanufacturing
Although automation is increasingly adopted in biomanufacturing, challenges remain in implementing it at the cell harvesting step.
Sustainability by Design in the Context of Bioprocess Development
Incorporating sustainable practices into process designs as early as possible ensures optimal performance.