There is a great need for sensitive, precise, and easily accessible analytical detection techniques for protein sequencing.

Biologics Quality Control: The Growing Need for Accessible Proteomics

The emergence of mRNA vaccines and cell and gene therapies has pushed innovation in analytical methods.

Emerging Therapies Drive Analytical Advancements

Effective analytics will eliminate failures, deviations, and non-conformances.

 Analyzing Exabytes

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Articles

Company completes first successful run of what is believed to be the largest synthesis-scale done for oligonucleotide APIs.

Nitto Avecia Completes Large-Scale Synthesis of Oligonucleotide

The companies have established a joint laboratory to develop full continuous processing to manufacture high yields of monoclonal antibodies at reduced costs.

WuXi and Pall Establish Continuous MAb Manufacture

The EMA’s Committee for Medicinal Products for Human Use has recommended marketing authorization approval for AstraZeneca’s benralizumab, a monoclonal antibody for treating severe asthma.

AstraZeneca Gets Positive EMA Opinion on Respiratory Biologic

The company expects to commercially launch the new vaccine in the US in the first quarter of 2018.

Dynavax Wins FDA Approval for Hep B Vaccine

CDMO Celonic acquired a biomanufacturing facility in Heidelberg, Germany from Glycotope.

Celonic Acquires Glycotope’s Biomanufacturing Facility

The companies will collaborate to develop and manufacture Grid’s lead therapeutic candidate for the treatment of solid tumors.

Catalent and Grid Therapeutics Form Immuno-Oncology Pact

Rita Peters is the former editorial director of 

Pharmaceutical Technology, Pharmaceutical Technology Europe

Industry experts were honored for business, scientific, and social contributions.

Awards Recognize Industry Contributions

SÃ¡ndor KemÃ©ny* is an emeritus professor at Budapest University of Technology and Economics, Faculty of Chemical Technology and Biotechnology, Department of Chemical and Environmental Process Engineering.

MÃ¡tÃ© Mihalovits is a PhD student at Budapest University of Technology and Economics.

In Part I of this article series, the regression control chart method for identifying out-of-trend data in pharmaceutical stability studies is investigated, and an improved approach is suggested. 

Methods for Identifying Out-of-Trend Data in Analysis of Stability Measurements–Part I: Regression Control Chart

Alex Wheeler is senior technician, bacterial endotoxin and cytotoxicity, at Wickham Laboratories Ltd., UK.

Inadequate endotoxin testing places patients at risk. Knowing the relative strengths and weaknesses of available test methods is crucial to maintaining quality and safety. 

Comparing Endotoxin Detection Methods

Natalia Belikova, PhD, is analytical services director at SGS Life Sciences, Lincolnshire, IL.

Hildegard Bruemmer, PhD, is operational laboratory manager at SGS Life Sciences, Germany. 

Forced degradation tests, conducted in early development stages, can provide insight into degradation pathways and products of a drug substance.


Analytics

Biologics Quality Control: The Growing Need for Accessible Proteomics

Emerging Therapies Drive Analytical Advancements

Analyzing Exabytes