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© 2020 MJH Life Sciences and Pharmaceutical Technology. All rights reserved.
© 2020 MJH Life Sciences™ and Pharmaceutical Technology. All rights reserved.
October 15, 2020
Analysts should understand how a monograph, together with the associated general notices and general chapters, relate to their responsibilities under good manufacturing practices.
October 07, 2020
The company’s new CytoML Experiment Suite fully automates each stage of the flow cytometry data lifecycle, allowing for clearer data visualization and analysis.
August 07, 2020
The award will help a bioanalytics startup commercialize instrument technology for pharmaceutical antibody manufacturers.
August 03, 2020
The company has launched a residual GMP-compliant test and dual sourcing opportunity designed to increase compliance and reduce risks for ATMP manufacture.
August 02, 2020
Dissolution testing is an important aspect of drug development as it provides stability parameters and helps predict drug behavior in-vivo.
July 02, 2020
The authors present a simple way to qualify a swab-sampling procedure for its ability to recover residues of a small-molecule API from cleaned equipment surfaces.
July 01, 2020
Appropriate analytical assays are needed to determine and ensure that biosimilar critical quality parameters are on track.
June 29, 2020
The company has provided updates on its COVID-19 tests under development with Adeptrix and Cytiva, respectively.
June 25, 2020
The importance of capability and capacity of a CDMO partner to deliver drug substance and product testing should never be underestimated, considering the increasing complexity of compounds in development.
June 03, 2020
Recent drug recalls in the United States from nitrosamine contamination prompt the need for more sensitive impurity testing methods and a re-evaluation of acceptable lower limit levels.
June 02, 2020
Bioanalytical studies are an important aspect of biologic drug development that may necessitate partnering with bioanalysis experts.
May 05, 2020
The extension of the company’s product offerings to include the anti-certolizumab pegol antibodies offers critical reagents for the development of assays for TNF alpha inhibitor biologics and their biosimilars.
April 30, 2020
A comprehensive turnkey system based on LabVantage’s laboratory information management system platform allows laboratories to implement COVID-19 biobanking, testing, and research.
April 07, 2020
Characterizing and controlling protein aggregation is vital to ensure safety and efficacy of a biopharmaceutical product. In this interview, important aspects of protein aggregation and the tools available to address this issue are discussed.
April 02, 2020
Because conventional cleaning methods can risk product loss, biopharmaceutical manufacturers are often reluctant to use PDE/ADE limits to validate cleaning processes.
March 06, 2020
The acquisition will expand Nexelis’ immunology testing expertise.
March 02, 2020
Metrology has the potential to not only prevent harm to patients but also to support innovative therapeutic options.
The authors present a simple-to-use Microsoft Excel-based statistical tool that uses cumulative sum techniques to aid retrospective understanding of data trends.
February 28, 2020
Eurofins DiscoverX partners with VelaLabs to enable VelaLabs to perform highly reproducible potency lot release assays under GLP/GMP conditions.
February 20, 2020
Bio-chromatography development and manufacturing company, BIA Separations, has signed a license agreement with the University of Zagreb to commercialize a novel elution method for virus and viral vector purification.