Biopharmaceutical Analysis

The results of an industry workgroup’s examination of EMA’s guide on shared facilities are presented.

This article defines the concept, justification, and method of removal of out-of-trend points in stability modelling and shelf-life prediction.

The company’s new version of its glycan analysis tool will help investigators determine the relative abundance of individual N-glycan structures in small biopharmaceutical samples.

Protea will use Agilent’s mass spectrometry imaging technology to develop new methods to identify cell metabolites produced as a result of disease or drug exposure.

Subjective visual evaluation of freeze-dried products can be quantified through mechanical methods of characterizing the properties these materials.

The authors evaluate the SoloVPE technique as a replacement for nitrogen-based protein determination.

Expectations are high for rapid testing methods, but demonstration of comparability proves challenging.

Advances in glycan analysis are enhancing biologics development and quality control processes.

Agilent Technologies and Thermo Fisher Scientific exchange instrument control drivers and software support.

FDA seeks feedback on possible analytical standards and approaches to optimize regulation of next-generation sequencing (NGS)-based in vitro diagnostic tests.

Whether taking an upstream, downstream or holistic approach, there are many factors to consider when choosing viral clearance methods.

The authors present a review of the techniques commonly used for glycosylation analysis.

Through the Glycoscience Program, the National Institute of Health will contribute $10 million to advance the study of carbohydrates and the compounds that interact with them.

This article introduces the technology that powers automated HT–DLS and explores its practical applications in enhancing formulation stability investigations.

The authors present the results of a survey of biologics manufacturers to evaluate how these manufacturers transfer analytical methods.

Surface plasmon resonance is helping define bispecific antibodies, the next-generation of biopharma therapeutics.

Dynamic light scattering techniques can monitor viruses and virus-like particles in their native state.

The National Biologics Manufacturing Centre will provide companies with open access to bioprocessing facilities and expertise to expedite low-risk market entry of complex biologics.

An approach to small-model generation and calibrating small-scale models to reliably predict performance at scale is presented.

Wilden’s Saniflo Hygienic Series pumps use a new, energy-efficient air distribution technology.

The RAN 3080 exterior washing machine from Bosch cleans filled and closed vials, ampuls, and cartridges using a high-pressure process and special transportation system.

Three case studies illustrate some analytical methods important for stability testing.

imagewerksBiophysical binding studies utilizing surface plasmon resonance, biolayer interferometry, isothermal titration calorimetry, or related techniques are ce

Sorendls/Getty ImagesTo maintain a state of control and comply with regulatory authorities, many pharmaceutical, biotech, and medical-device companies have adopted continued pro

Adents’ Pharma Suite serialization software features track-and-trace capabilities.

Ensuring data integrity involves effort on an individual and global basis.

The rapid microbiological growth-based method represents an alternative for the quantification of contaminants in filterable products.

GEA's self-contained homogenizer is designed for laboratory applications, including cell dispersions.

Industry experts spoke to BioPharm International about the key considerations in the development of a drug-delivery device for a biologic drug, the importance of human factors engineering, the advantages of prefilled syringes, and the challenges in the manufacture of these devices.