Laboratory Equipment

Application of an Effective In-Line Analytical Instrument for Biopharmaceutical Development and Manufacture

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The rapid advancement and competitiveenvironment of the modern biopharmaceutical industry, accompanied by the need for continuous quality improvement, demand robust analytical instruments. Analytical technology is one key factor contributing to the quality and safety of finished products. Ongoing improvements in analytical instruments are needed to address new challenges, including specificity of target substances, high complexity of matrices, and multiple production stages with a number of input and output parameters and peculiarities. Those factors point to the demand for a versatile…

March 2, 2023

eBook: BPI Lab — Contemporary Approaches to Data and Organization

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Laboratories provide essential support functions in biopharmaceutical development: from cell-line development through process validation, environmental monitoring, and preclinical analyses . . . to product characterization, formulation, and stability testing. Regulatory compliance is important across the gamut of such laboratory work. Modern companies are implementing lean concepts that facilitate organization and workflows in laboratory operations. And companies around the world can use the latest technology to ensure data integrity for their analytical results. Included herein are two articles that originally appeared…

October 18, 2022

A Tool for Rapid, Accurate Concentration Measurement of Biological Samples

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Conventional ultraviolet–visible spectroscopy (UV-vis) instruments use fixed optical pathlengths to measure analyte concentrations in biological samples. As Paul Mania (bioanalytics application specialist at Repligen) pointed out during an April 2022 presentation, such an approach requires sample dilution, which introduces risks for error and increases operator workload. Mania explained how the CTech SoloVPE instrument measures analyte concentrations at line without need for dilution, simplifying and accelerating analysis of samples from several downstream operations. Mania’s Presentation Traditional UV-vis instruments measure analyte absorbance…

September 28, 2022

eBook: Diagnostics — Developing Rapid and Accessible Testing Solutions

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The COVID-19 pandemic has brought myriad economic disruptions, social complications, and public-health calamities to the world. They have understandably overshadowed the silver lining of boosting biomedical science and technology in the realms of infectious disease, oncology, and more. But alongside the much-publicized commercial debut of novel vaccine technologies have come promising advances in medical diagnostics. In this eBook, BPI’s senior technical editor brings together perspectives from industry, academia, and expert organizations to highlight some of the latest diagnostic methods and…

December 16, 2021

Tools to Support COVID-19 Patient Testing

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To prepare adequate healthcare measures in the case of a pandemic, vast numbers of people must be tested in order to understand the dynamics and behavior of the infection cycle. The medical staff working under extreme circumstances need basic but reliable laboratory supplies to help contain the pandemic. Read this special report to discover two solutions for COVID-19 patient testing that comply with guidelines from the US Centers for Disease Control and Prevention (CDC) and World Health Organization (WHO). The…

September 15, 2021

Accelerating the Development and Manufacture of Therapeutics Using the Octet Platform

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The high costs of therapeutic discovery, development, and manufacture require improved process efficiencies and economics. Analytical tools that eliminate the need for reagent labeling and enable real-time data visualization save development time and improve efficiencies during process development. The Octet biolayer interferometry (BLI) platform and assays can be used throughout process development and manufacturing, including cell-line development, clone selection, and dynamic binding capacity (DBC) determination for affinity purification columns. The ability of the Octet BLI platform to monitor binding interactions…

September 15, 2021

Measuring Viral Titer in AAV-Mediated Gene Therapy Using a PCR Technique for Absolute Quantitation

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Gene therapies have reemerged as promising treatments to a number of genetic illnesses. Nearly 400 gene therapy clinical trials are recruiting or ongoing in the United States for diseases such as hemophilia and spinal muscular atrophy (1). The primary vehicles used today to deliver such therapies to patients’ cells are viral vectors such as adenoassociated viruses (AAVs), but producing biologically active vectors for gene therapy can be problematic. One difficulty is generating vectors at the correct concentration to yield a…

June 18, 2021

Cell-Line Development: Accelerating Antibody Discovery By Monitoring Titer and Glycosylation with the Octet Platform

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Cell line development involves the screening of thousands of clones in an effort to find the few optimal clones that are stable, grow as expected, and produce high yields of the bioproduct. The time it takes from engineering an optimal cell line to the production of the target biologic can be prohibitive and may differ from molecule to molecule. While expression-level analysis like titer screening is carried out early, other critical quality attributes (CQAs) such as glycan characterization are often…

June 11, 2021

Expanding the Flow Cytometry Toolkit with Next-Generation Polymer Dyes

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Since the emergence of SARS-CoV-2, scientists have discovered more about the role of our immune systems and cytokine-associated processes responsible for systemic immune reactions that are typical in patients with COVID-19 (1). Flow cytometry is used to understand those processes at a single-cell level. It is the standard method used in immunology to characterize multiple phenotypic and functional parameters of single cells, including cytokine analysis. Despite advances in flow cytometry instrumentation, reagents, and analytical software, several challenges remain. Conjugated antibodies…

May 21, 2021

Introduction: Technologies Converge in Biopharmaceutical Laboratories

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Bioassay development is foundational to the well-characterized biotechnology product paradigm. Bioassays are the best tools for drug developers to use in determining the biological activity (potency) of their products, which has been a biopharmaceutical critical quality attribute (CQA) since long before that concept had a name. Thus, these assays are vital to quality assurance and quality control (QA/QC), preclinical studies, and clinical testing — and by extension to process development and monitoring. Because of their complex nature, bioassays are among…

March 9, 2021