Single Use

Integrity of Single-Use Systems: Practical Applications and Deployment

Single-use (SU) technology plays an important role in modern vaccine and biologics manufacturing. System integrity, managed by critical process controls, ensures sterility and is a prerequisite for successful leak-free processing. Nonintegral systems cause loss of product, quality, and time; increase costs through investigations; and lead to potential safety problems. The BioProcess Systems Alliance (BPSA) issued a white paper in 2017, Design, Control, and Monitoring of Single-Use Systems for Integrity Assurance (1), that describes in detail the strategies for design and…

Single-Use Technology for Formulation and Filling: A Case Study from Swissfillon AG and Pall Corporation

Swissfillon AG is a contract manufacturing organization (CMO) based in Switzerland. Fully compliant with current good manufacturing practice (CGMP) regulations, it provides state-of-the-art aseptic filling for pharmaceutical and biotechnology companies, from clinical-phase materials to commercial quantities. This CMO specializes in high-value, difficult-to-fill products. Swissfillon recognized that adoption of single-use systems (SUS) on a commercial scale required major improvements in consistency and reliability compared to manual operations at pilot and clinical-trial scale. The single-use formulation and filling process, which includes an…

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…

Single-Use Systems for Storing and Shipping Frozen Drug Materials

Using presterilized, single-use freeze–thaw systems instead of traditional freeze–thaw platforms that include stainless-steel tanks and bottles can help biomanufacturers manage the quality of their drug substances. Single-use assemblies reduce the risk of cross-contamination, simplify dispensing, and decrease the number of manual interventions during freezing, thawing, handling, and shipping. However, implementing a freeze–thaw process requires careful testing of the physical and thermal properties of single-use systems and related aseptic connectors as well as assessment of drug-substance quality and stability. Such evaluation…

Benefits of Single-Use Standardization: Adopting a Standard Design Approach

It is widely accepted that standardization of single-use designs and assemblies would be beneficial to the biopharmaceutical industry, providing it quickly with simple and economical solutions. Meanwhile, as implementation of single-use technology increases across the biopharmaceutical industry, suppliers are struggling to keep up with demand. That has been evident particularly in current supply issues caused by the COVID-19 pandemic. A widely adopted single-use standardization approach could help alleviate such supply issues. That would not only benefit the industry by helping…

Embracing Innovation in Biomanufacturing

Innovations in bioproduction of therapeutics over the past 20 years have led to impressive improvements in product yield, process controls, and manufacturing safety. Industry 4.0 concepts have been embraced across the bioprocess industry and are leading to better bioprocess control through process automation, “big data” and data analysis, process simulations, the industrial internet of things (IIoT), cybersecurity, the cloud, blockchain/serialization, and additive manufacturing. Such advances help to ensure that a process results in the same outcome every time. As Sean…

Reacting to a Pandemic: Innovations in Vaccine Development

Traditionally, viruses for vaccines have been grown in embryonated hen eggs. But new challenges introduced by the COVID-19 pandemic have encouraged and catalyzed innovations in the field of vaccine development. The biopharmaceutical industry has recognized an advantage in mammalian cell-culture systems as promising alternatives to egg-based vaccine production. Cell lines can be cultured to large quantities in bioreactors, allowing for much shorter lead times, a more controlled production process, and a higher grade of reproducibility through standardization. In this article,…

The Green Imperative: Part Two — Engineering for Sustainability in Single-Use Technologies

In BPI’s June 2020 issue, the first installment of this series introduces the study and implementation of single-use (SU) technology to provide a more sustainable manufacturing environment (1). We presented evidence showing that the economic and social benefits of SU systems currently outweigh the residual environmental risks. Not only is SU technology often a better environmental choice than traditional biomanufacturing options, it also is sometimes the only choice for rapid process design and facility start-up. In situations such as the…

Silicone Tubing for Biopharmaceutical Applications: Particulates, Endotoxins, and Bioburden Characterization

Adoption of single-use systems (SUS) has increased steadily over the past few years driven by an increased focus on manufacturing biologics that require smaller scales than blockbuster drugs. Although SUS provide many benefits, some factors need to be considered when implementing them in biopharmaceutical production. With the regulatory landscape intensifying worldwide, drug manufacturers are expecting more data from suppliers to support the purity claims of supplied products, especially related to the purity of their product-contact surfaces. In this article, we…

Drug Formulations Are Changing:
New Sterile Filtration Challenges in the Changing Landscape of Drug Formulations

Read about the challenges of sterile filtration of high concentration mAbs, liposomes, and lentiviral vectors, and how to solve them in this Special Report. Development of new, complex drug formulations has given us therapeutics with properties that are markedly different from traditional drug types. High viscosity or low surface tension formulations or large viral vector molecules can mean that sterile filtration processes, which are optimized for traditional drug types, are not as efficient for the new, complex formulations. Premature filter…