2021

Accelerating the Development of Cell and Gene Therapies: From Discovery to Biomanufacture

Oxgene, a WuXi Advanced Therapies (WuXi ATU) company, provides cell and gene therapy pioneers around the world with technologies, automation platforms, and service solutions to advance their preclinical research and accelerate their timelines to good manufacturing practice (GMP) manufacturing. WuXi ATU, a global contract testing, development, and manufacturing organization (CTDMO), offers world-class, integrated GMP manufacturing and testing platforms to reduce time to market, while maintaining high titers, high levels of quality assurance, and full regulatory compliance. Together, our complete end-to-end…

Biopharmaceutical Development and CGMP Manufacturing: Expansion of Capacities for Clinical and Commercial Supply

Richter-Helm BioLogics is a leading and steadily growing contract manufacturer based in Germany. We comply with good manufacturing practice (GMP) and specialize in microbial biopharmaceutical products. Our work focuses on recombinant proteins, plasmid DNA, antibody fragments, and vaccines. Clients worldwide already have benefited from our commitment to GMP, flexibility, and total transparency. With a proven 30-year track record and highly skilled professionals, Richter-Helm supports you with process development, supply of products for clinical trials, commercial production, in-house quality control (QC)…

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

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

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

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…

eBook: Cell and Gene Therapies —
A 2021 Industry Update

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

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

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

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…