Peer-Reviewed Research

The authors present a methodology to assess the contribution of individual filters to overall capacity of the direct filtration train, and elucidate how capacity is affected by characteristics of the cell culture broth and process parameters, including for enhanced upstream processes such as those incorporating high cell density perfusion.

The authors give an overview of scaling approaches and present good scaling practices for the biopharma industry.

A survey was conducted to examine the adoption of machine learning and artificial intelligence in the bio/pharma manufacturing industry.

Use of a small-scale filler can result in increased filling efficiency.

In this article, a simple chromatographic model is proposed that is capable of predicting the impact of pH and ionic strength on HIC chromatograms.

In part 2 of this article, results from the testing of a next generation convecdiff membrane are discussed.

The testing of new convecdiff membranes shows this material to be well suited for lab- and commercial-scale bind-and-elute applications.

Using a minimum valuable product and process approach would make it is possible to discipline and structure the development of biopharmaceuticals in the fastest way possible.

This article introduces the requirements for a biosimilar license in Brazil and addresses questions about their quality, safety, and efficacy.

The business impact of modeling and simulation tools is not well understood and requires clarification of their benefits to drug development.

Establishing analytical workflows for complex biopharmaceutical molecules can help predict their risk of degradation.

Controlling certain atmospheric conditions in a closed NGI processing chamber can reduce bioburden without disinfectants.

A series of minute virus of mice spiking studies were performed with a monoclonal antibody product and small-scale AEX membrane adsorbers to evaluate a range of critical processing conditions.

Continuous SEC was shown to increase productivity with the same product quality and yield.

Advanced data analytics, including statistical modeling and machine learning technique, can enable more efficient and reliable bioprocesses.

This study aims to use plant-leaf extract for the green synthesis of gold nanoparticles and to evaluate their antibacterial and antioxidant activity.

In this study, a novel aldo-keto reductase was cloned and purified, and its important conserved sites were analyzed.

The authors present a risk analysis of the impact of various business and operating risks on three facility layout strategies.

A key technology that can help achieve a continuous production flow is single-pass tangential flow filtration.

This research proposes a method for separating and purifying tissue-type plasminogen activator from a fungal cell source.

The second half of this article describes the testing methods used by the authors to demonstrate the applicability of single-use mixing technology for virus inactivation.

Viral vaccines and viral vectors used in biotherapeutic applications carry the risk of microbial contamination, which must be addressed.

This study was successful in establishing a reliable and effective method for evaluating cleaning processes based on risk. Click here to view a PDF of this article.

The National Institute of Standards and Technology (NIST) has developed Standard Reference Material (SRM) 2082 as a pathlength standard for UV absorbance measurements for use with the new generation of microvolume spectrophotometers and short-pathlength cuvettes.

The authors present a robust and easy-to-implement chromatography column performance assessment method, called direct transition analysis (DTA).

. This study is an attempt to produce a fusion protein by binding the fragment NT-gp96 in upstream of sequence of the N terminal fragment (NT300) of the NS5B gene in an expression vector.

The control of biologics microbiological impurities, contaminants, and mimetics is evolving.

Amid debate about “fake news,” peer-review papers offer vital, objective insight.

This article provides an overview on important aspects related to bracketing strategies in Japan.

The objective of this study was to assess the impact of manufacturing-scale, freeze-thaw conditions on aggregation and subvisible particle formation of a monoclonal antibody solution (mAb-A; IgG1) using a small-scale model.