LC –MS Approach to Decipher a Light Chain Chromatographic Peak Splitting of a Monoclonal Antibody
ConclusionLiquid chromatography-mass spectrometry (LC –MS) has been utilized extensively to assess PQAs of biological therapeutics. In this study, a generalizable LC–MS-based approach was developed to enable identification and quantitation of the isoAsp-containing peptides. (Source: Pharmaceutical Research)
Source: Pharmaceutical Research - November 7, 2023 Category: Drugs & Pharmacology Source Type: research
Use of Resonant Acoustic Mixing Technology for Ultra-Low-Dose Blending in a Single-Step Mixing Process
ConclusionsThis study presents the first instance of a homogenously mixed<0.1% (w/w) blend using RAM technology and demonstrate the suitability for reproducible dosing of single-digit microgram drug amounts. Uniformity is documented for API amounts 60x smaller than a recent report has shown and 10,000x smaller than achieved previously with CAF. (Source: Pharmaceutical Research)
Source: Pharmaceutical Research - November 7, 2023 Category: Drugs & Pharmacology Source Type: research
LC –MS Approach to Decipher a Light Chain Chromatographic Peak Splitting of a Monoclonal Antibody
ConclusionLiquid chromatography-mass spectrometry (LC –MS) has been utilized extensively to assess PQAs of biological therapeutics. In this study, a generalizable LC–MS-based approach was developed to enable identification and quantitation of the isoAsp-containing peptides. (Source: Pharmaceutical Research)
Source: Pharmaceutical Research - November 7, 2023 Category: Drugs & Pharmacology Source Type: research
Use of Resonant Acoustic Mixing Technology for Ultra-Low-Dose Blending in a Single-Step Mixing Process
ConclusionsThis study presents the first instance of a homogenously mixed<0.1% (w/w) blend using RAM technology and demonstrate the suitability for reproducible dosing of single-digit microgram drug amounts. Uniformity is documented for API amounts 60x smaller than a recent report has shown and 10,000x smaller than achieved previously with CAF. (Source: Pharmaceutical Research)
Source: Pharmaceutical Research - November 7, 2023 Category: Drugs & Pharmacology Source Type: research
Fabrication and Characterization of Dissolving Microneedles for Transdermal Drug Delivery of Apomorphine Hydrochloride in Parkinson ’s Disease
ConclusionAPO-loaded dissolving MNs can deliver APO via skin into the systemic circulation with rapid absorption and high bioavailability. (Source: Pharmaceutical Research)
Source: Pharmaceutical Research - November 3, 2023 Category: Drugs & Pharmacology Source Type: research
Small is Powerful: Demonstration of the Impact of Nanoformed Piroxicam in a Controlled Clinical Study
ConclusionsThe results show that nanoforming enabled more rapid absorption in comparison to a typical marketed tablet and indicate that nanoforming is an alternative to complex formulation such as cyclodextrins based products. The study outcomes support the potential of nanoforming for producing fast-acting dosage forms of poorly soluble drugs. (Source: Pharmaceutical Research)
Source: Pharmaceutical Research - November 1, 2023 Category: Drugs & Pharmacology Source Type: research
Pharmaceutical and Immunological Evaluation of Cholera Toxin A1 Subunit as an Adjuvant of Hepatitis B Vaccine Microneedles
ConclusionsCTA1 is an adjuvant that satisfies both the delivery efficiency and the immunological characteristics required for vaccine microneedles. CTA1 will be used as a potential adjuvant through vaccine microneedles. (Source: Pharmaceutical Research)
Source: Pharmaceutical Research - November 1, 2023 Category: Drugs & Pharmacology Source Type: research
Benchmark Glycan Profile of Therapeutic Monoclonal Antibodies Produced by Mammalian Cell Expression Systems
ConclusionsThe findings of this study have significant implications for therapeutic antibody development, quality control, and regulatory compliance. The benchmark glycan profile enables the assessment of glycosylation consistency and comparability across a diverse range of antibody products, ensuring improved product quality within the biopharmaceutical industry. (Source: Pharmaceutical Research)
Source: Pharmaceutical Research - November 1, 2023 Category: Drugs & Pharmacology Source Type: research
A survey of FDA Approved Monoclonal Antibodies and Fc-fusion Proteins for Manufacturing Changes and Comparability Assessment
ConclusionOur comprehensive retrospective analysis provides an understanding of the regulatory experience and industry practice, which could facilitate developing appropriate comparability approaches to support manufacturing changes in the future. (Source: Pharmaceutical Research)
Source: Pharmaceutical Research - November 1, 2023 Category: Drugs & Pharmacology Source Type: research
A Stable Irinotecan Liposome with Enhanced Antitumor Activity in a Range of Tumor Models
ConclusionsOverall, the CPT-11 liposome may be developed as a new clinical alternative for the cancer patients. (Source: Pharmaceutical Research)
Source: Pharmaceutical Research - November 1, 2023 Category: Drugs & Pharmacology Source Type: research
Small is Powerful: Demonstration of the Impact of Nanoformed Piroxicam in a Controlled Clinical Study
ConclusionsThe results show that nanoforming enabled more rapid absorption in comparison to a typical marketed tablet and indicate that nanoforming is an alternative to complex formulation such as cyclodextrins based products. The study outcomes support the potential of nanoforming for producing fast-acting dosage forms of poorly soluble drugs. (Source: Pharmaceutical Research)
Source: Pharmaceutical Research - November 1, 2023 Category: Drugs & Pharmacology Source Type: research
Pharmaceutical and Immunological Evaluation of Cholera Toxin A1 Subunit as an Adjuvant of Hepatitis B Vaccine Microneedles
ConclusionsCTA1 is an adjuvant that satisfies both the delivery efficiency and the immunological characteristics required for vaccine microneedles. CTA1 will be used as a potential adjuvant through vaccine microneedles. (Source: Pharmaceutical Research)
Source: Pharmaceutical Research - November 1, 2023 Category: Drugs & Pharmacology Source Type: research
Benchmark Glycan Profile of Therapeutic Monoclonal Antibodies Produced by Mammalian Cell Expression Systems
ConclusionsThe findings of this study have significant implications for therapeutic antibody development, quality control, and regulatory compliance. The benchmark glycan profile enables the assessment of glycosylation consistency and comparability across a diverse range of antibody products, ensuring improved product quality within the biopharmaceutical industry. (Source: Pharmaceutical Research)
Source: Pharmaceutical Research - November 1, 2023 Category: Drugs & Pharmacology Source Type: research
A survey of FDA Approved Monoclonal Antibodies and Fc-fusion Proteins for Manufacturing Changes and Comparability Assessment
ConclusionOur comprehensive retrospective analysis provides an understanding of the regulatory experience and industry practice, which could facilitate developing appropriate comparability approaches to support manufacturing changes in the future. (Source: Pharmaceutical Research)
Source: Pharmaceutical Research - November 1, 2023 Category: Drugs & Pharmacology Source Type: research
