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
FDA Provides Guidance on Advanced Manufacturing Technologies Program
FDA provides recommendations for those interested in participating in the agency's Advanced Manufacturing Technologies Designation Program.
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 Reopens Comment Period on HCP Immunogenicity Risk of Follow-on Recombinant Peptides
FDA is reopening the comment period for the Federal Register Notice, “Evaluating the Immunogenicity Risk of Host Cell Proteins in Follow-on Recombinant Peptide Products: Establishment of a Public Docket: Request for Information and Comments”, until March 3, 2025.
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.
The Benefit of Technological Advancements to BsAb Development
Advancements in bioprocessing and analytics are crucial to the future development of bispecific antibodies and beyond.
Top 10 Video Interviews of 2024
The BioPharm International editors present our most popular video interviews from 2024.
FDA Provides Guidance on Advanced Manufacturing Technologies Program
FDA provides recommendations for those interested in participating in the agency's Advanced Manufacturing Technologies Designation Program.
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 Reopens Comment Period on HCP Immunogenicity Risk of Follow-on Recombinant Peptides
FDA is reopening the comment period for the Federal Register Notice, “Evaluating the Immunogenicity Risk of Host Cell Proteins in Follow-on Recombinant Peptide Products: Establishment of a Public Docket: Request for Information and Comments”, until March 3, 2025.
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.
The Benefit of Technological Advancements to BsAb Development
Advancements in bioprocessing and analytics are crucial to the future development of bispecific antibodies and beyond.
Top 10 Video Interviews of 2024
The BioPharm International editors present our most popular video interviews from 2024.