Quality Control Takes Center Stage; Emerging Therapies Test Existing Bioanalytical Methods

Pharmaceutical Technology In the Lab Monthly Issue:
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May 2019
Volume 14 Issue 5

In This Issue

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Features

The Importance of Particle Characterization

To achieve high-quality pharmaceutical product, it is important to characterize the drug particles and understand the behavior of bulk powder.
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Emerging Therapies Test Existing Bioanalytical Methods

Drug developers must understand the complex bioanalytical assays for cell- and gene-therapy drug development programs and ensure that partners have the specialized expertise needed for complex therapeutic classes.
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Determining Biopharma Quality Through Computational Glycosylation Modeling

Glycosylation modeling is a useful tool for determining biopharma product quality, and establishing collaboration between academic and industrial groups ensures that such modeling tools are fit for use.
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News

FDA Issues Bispecific Antibody Development Guidance

The agency provides recommendations for the development of bispecific antibody development programs that include regulatory, quality, nonclinical, and clinical considerations.
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Protagen Protein Services, BioAnalytix Merge into CRO

The companies will merge to offer a broader range of analytical data packages and regulatory support for biopharmaceuticals.
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QC Lab Extends Capabilities at Cambrex’s Milan Facility

Cambrex’s expanded quality control (QC) laboratory supports generic API development.
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3M Relocates R&D to Life Sciences Opportunity Zone in Loughborough, UK

3M Drug Delivery Systems UK organization has revealed that it is relocating its R&D team to the Charnwood Campus, which is an officially designated Life Sciences Opportunity Zone in Loughborough, United Kingdom.
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Improvement in CAR T-Cell Therapy Removes Severe Side Effects

University of Southern California scientists have made an advancement in chimeric antigen receptor (CAR) T-cell therapy that seems to eliminate its severe side effects, making the treatment safer and potentially available in outpatient settings.
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Thermo Fisher, Genovis Collaborate to Advance Characterization and Monitoring Methods

The companies will join forces on a research project to develop end-to-end workflows for the preparation, characterization, and monitoring of biotherapeutics using liquid chromatography-mass spectrometry.
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