Biopharmaceutical Analysis

The guidance provides recommendations for submitting analytical procedures and method validation data to FDA.

The collaboration will address the need for novel analytical approaches for the characterization of glycans.

Charles Rivers strengthens its endotoxin testing and bacterial identification detection capabilities with the addition of Celsis’ products.

The challenges and strategies of assessing and mitigating risk in biopharmaceutical manufacturing are discussed.

Advances in adventitious agent detection methodology are bringing benefits, but more work needs to be done.

Low endotoxin recovery represents an opportunity to add value to the characterization of biologic drug products.

Approaches to the generation of process models, optimization techniques, and application of a design space are explored.

GEA’s Panther NS3006L high-pressure homogenizer is a standalone unit designed to reduce particle size to nanometer ranges.

A new demonstration facility in New York gives Sartorius’ customers hands-on access to bioprocessing systems and lab instruments.

This article reviews the definition of HCPs, risks posed by HCPs, regulatory concerns, commonly accepted ELISA methods for HCP measurement and their limitations, and orthogonal methods available for HCP characterization.

This article reviews factors that affect protein stability at different steps of the product manufacturing process and strategies to minimize their impact on product quality.

Biopharma companies on both sides of the Atlantic ship more of their assay testing to outside service providers.

Higher cell densities, greater demand for high-performance viral clearance, and desire for large-scale single-use technologies are driving development of filtration technologies.

The rapid testing of biologic raw materials can lead to greater efficiency.

The authors review major developments in use of MVDA in bioprocessing applications.

This article presents first-hand perspectives from industry users to suppliers of single-use sensors.

Liquid particle counters are ideal for protein aggregation studies.

Care needs to be made to match the method of limit determination to the analytical method.

The agency outlines recommendations for the development and submission of near infrared analytical procedures.

The thorough analysis of a therapeutic protein product’s propensity to aggregate may be a necessary step in the prevention of a cell-mediated immune response.

MedImmune will provide funds and access to monoclonal antibodies to seven postdoctoral associates for the creation of protein measurement and characterization tools.

As ADCs move through the drug-development process, different analytical methods are often required.

Understanding the influence of change events on product performance is a necessity to routine drug development, transfer, and validation.

The use of commercially available media to achieve high titer in early process development is discussed.

The author discusses the various ways in which a quality-by-design program can enhance the extractable and leachable assessment of a drug product.

New drugs submitted for approval in Europe have 18 months to comply with new elemental impurities guidelines.

A new study conducted by the National Institutes of Health found that a certain vector used in gene therapy (and its insertion site in the genome) may be associated with an increased risk of liver cancer.

USP establishes Jan. 1, 2018 as the implementation date for its elemental impurities guidelines for existing drugs.

Understanding and preventing protein aggregation is crucial to ensuring product quality and patient safety.

Ligand-binding assays are fundamental to characterizing biosimilars.