Peer-Reviewed Research

This report describes the first known attempt at quantifying the success of such processes in inducing nucleation on a 56–m2 freeze dryer operating at a load of 195,960 vials.

To investigate the best culture conditions, the authors used response surface methodology via Box-Behnken design.

An approach to stabilize PBS-based formulations could provide a simple physiological solution for use of proteins in research, preclinical, diagnostics, and clinical studies, as well as commercial biotherapeutic products.

This study offers a strategy for stabilization of biotherapeutics for long-term frozen storage in PBS-based formulations.

The study demonstrates a systematic approach to stabilize PBS-formulated mAbs against freeze-thaw degradation.

The authors present an overview of the types of RNA-based therapeutics in existence and their optimal methods of manufacture, purification, formulation, and delivery.

Data acquired from osmolality, glucose, and folic acid tests provides useful information for the specific identification of cell-culture media.

The authors provide application data to support the use of SEC beyond small-scale operations.

The authors describe the ways in which manufacturers can mitigate the risks related to the integrity of recombinant transgenes expressed in CHO cells.

The authors explore the use of precipitation using polyvinyl sulfonic acid and zinc chloride in place of capture chromatography to reduce the cost of goods in the insulin manufacturing process.

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

This case study reviews how quality-by-design principles can be implemented in an intermediate chromatography purification step that uses cation-exchange chromatography.Abstract

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

The authors explore the use of statistical experimental design and multivariate analysis to develop a drug substance formulation matrix.

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

Differentiation and Characterization of Protein Aggregates and Oil Droplets in Therapeutic Products

Liquid particle counters are ideal for protein aggregation studies.

The authors review efforts to limit polymer degradation without significantly impeding cell growth.

The use of orthogonal methods to SEC is discussed and examples are presented showing how analytical ultracentrifugation, AF4, and SEC compare in aggregate quantitation.

Fed-batch processes were scaled up from traditional bench-scale bioreactors to large-scale single-use systems.

Different approaches to prepare highly concentrated feed media for fed-batch Chinese hamster ovary cell culture are evaluated.

Review regulatory requirements and the use of viral-challenge studies in drug development.

The presence of minute amounts of chelators can help minimize the degradation of monoclonal antibodies.

This series presents a practical roadmap in three parts that applies scientific knowledge, risk analysis, experimental data, and process monitoring throughout the three stages of the process validation lifecycle. In Parts I and II, risk analysis and process characterization studies were used to assign criticality risk levels to critical quality attributes and critical process parameters, and the concept of a continuum of criticality was established. In Part III, the author applies the continuum of criticality to develop the process control strategy and move through Stages 2 and 3 of the new process validation lifecycle.

Accurate protein concentration results can be obtained using standard spectrophotometers and commercially available short path length absorption cells.

Criticality is used as a risk-based tool to drive control strategies.

Criticality is used as a risk-based tool to drive control strategies.

A study to investigate metacomplex formation in the hetero-association of a multivalent antigen, streptavidin (SA), and a bivalent antibody (Ab) using a composition-gradient multiangle light-scattering (CG-MALS) system consisting of a composition-gradient device, a MALS detector, and a UV/Vis absorption detector.

The correlation between limulus amebocyte lysate (LAL) assay and rabbit pyrogen test (RPT) targeting recombinant human epidermal growth factor (rhEGF) as active molecule was assessed.