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
Exogenus Therapeutics Partners with Lonza on Manufacture of Exosome-Based Candidate
Lonza will develop a GMP-compliant process for Exogenus’ exosome-based lead candidate, Exo-101, at its Sienna, Italy site.
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.
Australia Regulatory Authority Declines Approval of Eisai’s Lecanemab for Early Alzheimer’s Disease
The Therapeutic Goods Administration (TGA) of Australia confirmed its initial decision to decline approval of the mAb for treating early Alzheimer’s disease.
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.
Comparative Deterministic Cold Storage Headspace Analysis–Multi-sourced Injectable Container Closure Systems
This study evaluates the best-in-class elastomer compounds, formulations, and coatings, affixed with aluminum seals and press-on caps to Type I borosilicate tubular glass vials conforming to the International Organization for Standardization (ISO 8362) injection containers requirements.
EMA Recommends Imfinzi-Based Perioperative Regimen for Treating Resectable NSCLC
The committee’s recommendation is based on results from a Phase III trial in which Imfinzi demonstrated a reduced risk of recurrence, progression, or death by 32% compared to neoadjuvant chemotherapy alone.
Exogenus Therapeutics Partners with Lonza on Manufacture of Exosome-Based Candidate
Lonza will develop a GMP-compliant process for Exogenus’ exosome-based lead candidate, Exo-101, at its Sienna, Italy site.
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.
Australia Regulatory Authority Declines Approval of Eisai’s Lecanemab for Early Alzheimer’s Disease
The Therapeutic Goods Administration (TGA) of Australia confirmed its initial decision to decline approval of the mAb for treating early Alzheimer’s disease.
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.
Comparative Deterministic Cold Storage Headspace Analysis–Multi-sourced Injectable Container Closure Systems
This study evaluates the best-in-class elastomer compounds, formulations, and coatings, affixed with aluminum seals and press-on caps to Type I borosilicate tubular glass vials conforming to the International Organization for Standardization (ISO 8362) injection containers requirements.
EMA Recommends Imfinzi-Based Perioperative Regimen for Treating Resectable NSCLC
The committee’s recommendation is based on results from a Phase III trial in which Imfinzi demonstrated a reduced risk of recurrence, progression, or death by 32% compared to neoadjuvant chemotherapy alone.