2021 Archives - Page 10 of 21 - BioProcess InternationalBioProcess International

eBook: Cell and Gene Therapies —
A 2021 Industry Update

by Dan Stanton, Gareth Macdonald, Joe Neroni and Salome Philip

The US Food and Drug Administration (FDA) reports that as of June 2021, 22 advanced therapy products have received regulatory approval in the United States. The first such product gained regulatory approval in 2010. Since then, hundreds of cell and gene therapies have advanced to clinical evaluation, but few products have reached commercial stages — and those that have done so have been hindered by manufacturing problems. In this eBook, writers from the BioProcess Insider and Project Farma analyze trends…

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…

Design and Performance of a New Single-Use pH Sensor with Long Shelf Life and High Stability

by Ben Arriola and Jinbo Hu

Single-use biopharmaceutical manufacturing systems require gamma-sterilizable, highly stable, accurate, and simple-to-use single-use pH sensors with a long shelf life. Herein we report the design and performance of a single-use pH sensor technology optimized for single-use bag applications such as those found in bioreactor and mixing applications. This technology is the basis of Emerson’s Rosemount 550pH Single-Use Sensor. The sensor is compatible with gamma irradiation and can be attached to a single-use bioreactor bag via industry accepted ports. With the incorporation…

Clamp-On Flow Meters for Process Monitoring

by Fernando Rangel

Process monitoring entails systematic recording or measurement of an operation or process by means of technical aids. Repeated, regular execution is a central element of that activity. Statistical process control and management help to optimize and stabilize processes. They also ensure appropriate monitoring of threshold values. Ultrasound-based clamp-on flow meters are ideal measuring methods for that purpose because they enable data collection without requiring operators or equipment to intervene in a process. Noncontact flow sensors also combine high precision with…

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…

eBook: Process-Related Impurities — Emerging Strategies for Detection, Identification, and Management of Host-Cell Proteins

by Brian Gazaille

Host-cell proteins (HCPs) represent a major class of process-related impurities (PRIs) that are generated during biopharmaceutical manufacture. Although the vast majority of such proteins are removed from a drug substance during downstream purification, residual HCPs can remain in a finished drug product. Even in minimal concentrations, copurifying HCPs can pose safety risks and compromise protein-product yield, efficacy, and stability. Thus, regulatory agencies consider the presence of HCPs to be a critical quality attribute (CQA). Sufficient clearance of these impurities helps…

Contractor Perspectives: Best Practices for Transfer, Handling, Testing, and Storage of Cell Banks

by S. Anne Montgomery, Scott Wheelwright and H. Fai Poon

For comments about how contract development and manufacturing organizations (CDMOs) manage their cell-banking quality assurance (QA) practices. I contacted long-time member of BPI’s Editorial Advisory Board Scott M. Wheelwright, PhD, for his perspectives. Wheelwright brings many years of experience to this discussion, with insights into the evolution of technologies and practices extending back to the early launch of the biopharmaceutical industry. Currently, he provides consulting support for companies with manufacturing and sourcing in China and other Asian countries. He also…