Peer-Reviewed Research

This paper outlines a systematic approach to detecting contamination through process deviations, including changes in % dissolved oxygen, pH, and metabolic patterns.

This study evaluates the best-in-class elastomer compounds, formulations, and coatings, affixed with aluminum seals and press-on caps to Type I borosilicate tubular glass vials conforming to the International Organization for Standardization (ISO 8362) injection containers requirements.

In this article, the authors explored the elimination of a water rinse and blow down following the caustic wash step, examining potential safety considerations, the effect on the quality of the cleaning process, and the potential benefit of implementing this change.

This research focuses on refining the clarification step by assessing the performance of various depth filters. The study explores both conventional cellulose-based and innovative synthetic depth filters, utilizing pneumococcal fermentation harvests from two challenging serotypes.

The authors evaluated the potential of direct filtration for multiple biopharmaceutical candidates. This article is Part 2 of the study.

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.