2021

Tools to Support COVID-19 Patient Testing

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…

Accelerating the Development and Manufacture of Therapeutics Using the Octet Platform

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…

New Antibody Formats on the Block:
More Complex Modalities Demand Innovation in Manufacturing and Purification

Some of the latest, most promising therapeutic developments in the biologics industry use antibody fragments — either separate functional subunits of antibodies or recombinant molecules that are composed of immunoglobulin domains. The most popular fragments are antigen-binding fragments (Fabs), variable single-chain fragments (scFvs), diabodies, and nanobodies. Such molecules raise several advantages over their parent molecules for upstream production but pose several challenges for downstream purification. To facilitate antibody-fragment capture, Tosoh Bioscience has developed Toyopearl AF-rProtein L-650F resin. Its ligand uses…

eBook: Product Variants in Bioprocesses

Product variants are contaminants because they bear properties that are different from those of desired biological products with respect to activity, efficacy, and safety. Thus, such variants can compromise product quality and consistency. In this eBook, Yuval Shimoni explores different types of variants — including primary-sequence variants, undesirable posttranslational modifications, aggregates, and degraded proteins — and explains how their presence can diminish the performance and quality of drug substances and products. He also discusses how product variants form at different…

High-Yield AAV Viral Vector Production in Corning Ascent Fixed-Bed Reactor System

Gene therapies hold great promise for one-time treatments that alleviate or cure certain genetic conditions. Recombinant adenoassociated viral (AAV) and lentiviral vectors have emerged as leading gene delivery methods for in vivo and ex vivo gene therapies, respectively. With more than 500 gene therapy clinical trials underway, the industry needs scalable, cost-efficient viral vector manufacturing. To address those needs, Corning developed the Ascent fixed-bed bioreactor system for scalable, high-density, adherent cell culture, including high-yield viral vector manufacturing. The Ascent fixed-bed…

Model-Based Process Monitoring of Algae Cultures Using eve Software

In bioreactor processes, the on-line monitoring of key parameters relies on the use of adequate sensors. In this article, we implement model-based software sensors to monitor nitrate concentrations in an algae batch process. Nitrate concentration is a crucial component in algae growth, and its assessment is used to achieve optimal growth conditions or to determine optimal harvest times. Batch cultivation of the algae Chlamydomonas reinhardtii is carried out in a Labfors 5 airlift photobioreactor provided by INFORS-HT. By means of…

PendoTECH Sensors and Industry 4.0: Integrating a PendoTECH Single-Use Sensor System with a Digital Highway

Biopharmaceutical manufacturing is evolving with the progression of Industry 4.0. Industry 4.0 refers to the ongoing “fourth industrial revolution,” which is transforming modern manufacturing and production practices through the use of “smart” technology. This is appealing especially to the biopharmaceutical industry, where production can be a long, meticulous, complex process, and optimizing manufacturing procedures is critical for success. As a leading supplier of single-use technology for the biopharmaceutical industry, PendoTECH recently has explored how its products can be integrated easily…

High Virus-Titer–Producing Cell Lines for Bioproduction

Antiviral vaccines are essential for preventing epidemic disease. However, production of them often is limited by low-yielding manufacturing processes. Similarly, the development of gene therapies is constrained during the production of adenoassociated virus (AAV) delivery platforms for gene transfer. To address the need for efficient viral synthesis to quicken the pace of bioproduction, ATCC used CRISPR/Cas9 genome-editing technology to develop STAT1 and BAX knockout (STAT1 BAX KO) cell lines to produce high-titer viral stocks. Three cell lines optimized for virus…

28 Years of Experience Developing and Manufacturing Biopharmaceuticals

Avid Bioservices, Inc. is a full-service, dedicated contract development and manufacturing organization (CDMO) focused on biopharmaceutical drug substances derived from mammalian cell culture. Avid’s services include process development and current good manufacturing practice (CGMP) clinical and commercial drug-substance manufacturing, bulk packaging, release and stability testing, and regulatory submissions support. For early stage programs, the company provides process development activities such as upstream and downstream development and optimization, pilot-scale manufacturing, analytical methods development, and testing and characterization. Avid has 28 years…

Partnering with Innovators: From Raw Materials to Commercial-Ready Processes

Advancements in life sciences technologies and the increasing demands for improved, effective, and innovative products to prevent, treat, and in some cases, cure diseases have focused the attention of drug developers on new modalities such as mRNA-, DNA-, viral vector-, and cell-based therapies and vaccines. Novel biopharmaceutical products bring a level of complexity to developing and bringing them through design, clinical studies, and to the market. Like traditional drug products, complex therapies require robust, scalable manufacturing processes, a reliable quality-driven…