Analytics

Regulations and industry guidelines focus on ensuring excipient safety by specifying risk assessments and shared responsibility.

Proposed guidance documents assist drug manufacturers in qualifying single-use systems for commercial drug production.

Cambrex invests in development and laboratory facilities and adds staff.

Successful outsourcing relationships in early phase drug-development analytics are driven by partnership.

Joe DiMasi, director of economic analysis and research associate professor, Tufts Center for the Study of Drug Development (CSDD), discussed research into the impacts of working with single source contractors with Pharmaceutical Technology.

Particulate modelling has the potential to transform productivity within the pharmaceutical manufacturing industry, speeding up production cycles, reducing manufacturing costs, improving efficiency, and driving inward investment, with the potential to reinstate the UK as a global manufacturing powerhouse.

The new Acquity Arc Bio System by Waters is specifically engineered to enable efficient transfer and improvement of bioseparation analytical methods.

Corning will feature its 3D bioprinting technology and tools to support 3D cell culture at booth #1029 during the SLAS 2018 conference on Feb. 3-7, 2018 in San Diego, CA.

The Fluent Gx Automation Workstation from Tecan is suited for a variety of clinical and regulated laboratory applications.

Formulatrix's Rover Laboratory Automation Platform to support sample preparation will be featured at booth #1335 during the SLAS conference in San Diego, CA, on Feb. 5-8, 2018.

Comecar will provide cell culture equipment for biopharmaceutical company CO.DON AG's new production site in Leipzig, Germany.

KBI Biopharma's acquisition of Elion Labs expands KBI's biophysical and analytical characterization capabilities.

Carver will feature its Auto Series Plus automatic hydraulic laboratory press at Pittcon 2018.

1CryoBio’s Flexiquot technology allows for the deep-freeze storage and handling of multiple aliquots in a single tube, winning it the CPhI Pharma Award 2017 for Excellence in Pharma: Analysis, Testing, and Quality Control.

Lonza Pharma & Biotech's's Modular Automated Sampling Technology (MAST) platform, which allows for the collection of up to 10 sterile sample sources for automated analysis in multiple analytical devices, won the CPhI Pharma Award 2017 for Excellence in Pharma: Bioprocessing.

The NGC Fraction Collector from Bio-Rad Laboratories allows researchers to choose how to collect and when to access their fractions for analytical or preparative chromatography applications.

The acquisition strengthens Charles River Laboratories’ capabilities in the oncology and immunology therapeutic areas.

Automated Control Concepts has launched Lab Owl bioreactor control system for labs using cell culture and fermentation applications.

The 2018 Short Course program at Pittcon, taking place Feb. 24–Mar. 1, will feature 23 new short courses geared towards laboratory professionals.

In a roundtable Q&A with biopharma executives, the vulnerability and challenges of dealing with extractables and leachables in single-use bioreactor bags are explored.

The Industrial Internet of Things can be used in the bio/pharmaceutical industry to monitor equipment health, optimize processes, and enable modular facilities.

Measurements by a drone-based online pressure monitoring system help identify weak points in the filling line, enabling the process to be optimized.

The authors offer recommendations for permissible daily exposures and concentration limits of elemental impurities for dermal drug products.

BioTek Instruments has released a second edition of its BioSpa software that now offers users a simplified but effective interface for kinetic imaging or detection workflows.

The Endress+Hauser iTHERM TrustSens hygienic RTD self-calibrates to verify in-line that the sensor is working as designed

SGS has introduced a Sanger sequencing service at its Glasgow, United Kingdom, laboratory to support genetic stability testing and perform identity testing on cell banks, plasmids, and viral seeds/vectors.

Biopharma majors are among the industry stakeholders who have commented and raised questions about FDA’s recently proposed draft guidance for analytical assessment of similarity in biosimilars.

Amid business and regulatory uncertainty, bio/pharma experts reveal opinions on salary, recognition, and training.

Medherant has developed an improved instrument for testing drug release from transdermal patches.

In Part I of this article series, the authors discussed the regression control chart method for identifying out-of-trend data in pharmaceutical stability studies. In Part II, the by-time-point method and the multivariate control chart method are investigated, and improved approaches are suggested. The method is illustrated using real data sets.