Industry Innovators 2021-2022 Archives - Page 2 of 3 - BioProcess InternationalBioProcess International

Freeze Cycle Testing of
Fluoropolymer Bottles

Frozen storage of bulk drug substances (BDS), including bioprocess solutions, vaccines, blood components, and other delicate process fluids is common in the bioprocess industry. Vessels used to store those fluids must be capable of withstanding long-term storage in extremely cold temperatures (e.g., –85 °C or –196 °C), sometimes for very long time periods. They also must also maintain integrity after repeated thawing and subsequent refreeze. The study below was performed to characterize performance of fluoropolymer bottles with standard and two-piece…

Autologous CAR T Cell Manufacturing Using a Semiautomatic, Closed, Modular Workflow: Seamless Transition from Discovery to Clinical Manufacturing

by Sean Chang

Chimeric antigen receptor (CAR) T cell therapies have advanced rapidly in recent years, with a number of targets in clinical research and several US Food and Drug Administration (FDA)-approved products already on the market. There has been tremendous effort to make CAR T cells more effective, safe, and persistent when treating patients. On the manufacturing side, however, errors, lot-to-lot variation, and contamination can be associated with open processes and manual handling of CAR T cells. Cell isolation, gene editing, expansion,…

Prepared for the Future?
Smart Maintenance Is Key to Industry 4.0

by Martin Mayer

With the rapid advancement of digitalization, new technologies and flexible production concepts have become essential parts of the biopharmaceutical industry, especially for implementing Industry 4.0, the Internet of things (IoT), and predictive maintenance. As an expert partner for digitalization, Zeta supports its customers with new tools for smart maintenance. Swift commissioning helps biomanufacturers complete their projects successfully. That requires trained personnel and maintenance support. Intelligent tools based on digital plant data ensure smooth operation. Smart Maintenance Navigator (SMN) technology is…

Enabling High-Performing
Perfusion Cell Culture

by Benjamin Madsen and Chris Brau

At least one report estimates that by 2025, 35% of biologics will be manufactured using enhanced processes, particularly perfusion-based bioprocessing. Results of two innovations that support this need for enhanced processes are examined below. The Thermo Scientific HyPerforma DynaDrive Single-Use Bioreactor (SUB), the latest advancement in SUB technology, offers better performance than other bioreactors and scalability up to 5,000 L. Gibco High-Intensity Perfusion CHO Medium is formulated to provide exceptional performance and ease of use, with capability of sustaining >1…

The iCapTag Protein Purification Platform: Bridging Research and Manufacturing

by Izabela Gierach and David W. Wood

Purification of recombinant proteins remains a critical challenge for applications ranging from basic biological research to the development and production of lifesaving biopharmaceuticals. At laboratory scales, the rapid purification of large numbers of new and uncharacterized protein targets effectively compels the use of affinity tags, which enable reliable purification using simple, established protocols with minimal optimization. Tags cannot be used for therapeutic applications, however, because of their potential for immunogenicity. Thus, for proteins other than monoclonal antibodies (which typically use…

Your Partner for Host Cell Protein Analytics for Over 25 Years

by Alla Zilberman

Cygnus Technologies, part of Maravai LifeSciences, is the biopharmaceutical industry’s partner in host cell protein (HCP) and other process-related impurity detection and analytics. In addition, Cygnus now provides innovative viral clearance solutions. Cygnus helps companies developing therapeutic proteins, vaccines, antibodies, plasma derivatives, and gene therapies ensure the safety of their biotherapeutics before human trials, regulatory approval, and commercial release. Cygnus provides analytical tools and solutions for improving bioprocess development for faster regulatory approval and better clinical outcomes. Cygnus is an…

Achieve Best-in-Class Purification with the Avantor J.T.Baker BAKERBOND PROchievA Resin

by Jungmin Oh

There is an established, global pipeline of existing and upcoming monoclonal antibody (MAb) drugs that treat a wide variety of clinical indications. In MAb manufacturing, protein A chromatography is a proven downstream purification process, but there remains a need to reduce total costs while improving purity and yield. The Avantor J.T.Baker BAKERBOND PROchievA recombinant protein A chromatography resin advances the production of MAbs by providing different choices to biopharmaceutical supply chains. Offered both as a bulk resin and as prepackaged…

Scalable, Real-Time Bioprocess Monitoring Solution: Kaiser Raman Technology and Sartorius BioPAT Spectro Yield Value from Early Process Development to Single-Use Manufacturing

by Maryann Cuellar

Raman spectroscopy is used in biomanufacturing as a process analytical technology (PAT) tool for making rapid, nondestructive, in-process measurements. However, Raman data collection at early stages of bioprocess development has been a challenge because of the lack of interface to bioreactors <250 mL. Realizing the industry was struggling to capitalize on the full potential of Raman spectroscopy, Kaiser Optical Systems, Inc. (Kaiser), an Endress+Hauser company, collaborated with Sartorius to bring Raman to Ambr 15 microbioreactors (10–15 mL) and Ambr 250…

Take Complexity and Risk Out of Regulatory Compliance

by Chantale Julien

Novo Nordisk Pharmatech’s high-purity, nontherapeutic insulin is sourced directly from the Novo Nordisk parent company, the world’s largest insulin producer. The product consists of insulin human crystals that are biosynthetically produced by recombinant microbial expression in yeast. Insulin human AF stimulates the proliferation of cells and enhances the yield, and it is a key component in serum-free growth media for mammalian cells. Insulin human AF is used for manufacturing monoclonal antibodies, virus vaccines, gene therapies, and other biological drug products…

Continuous Biomanufacturing Implementation: Using an Intensified and Integrated Bioprocess Platform

by Weichang Zhou, Hang Zhou, Mingyue Fang and Siyuan Tang

Recent world events have demonstrated now more than ever the growing demand for pharmaceutical biologics that can be made rapidly and in high volumes yet somehow remain affordable. Hence, there is an urgent need to develop a next-generation biomanufacturing solution that provides high-yield, high-quality drug products and is highly flexible and cost-effective. Herein we describe the WuXi Biologics ultrahigh productivity platform (WuXiUP), an intensified perfusion culture process developed to meet the aforementioned need. WuXiUP adopts process-intensification strategies on to traditional…