Single Use

A Single-Use Process for Production of Recombinant Human Follicle-Stimulating Hormone

Follicle-stimulating hormone (FSH) is a heterodimeric glycoprotein consisting of noncovalently linked α and β subunits. It stimulates the growth of immature follicles in ovaries and primary spermatocytes in testes and thus plays an important role in human reproduction (1). Human menopausal gonadotropin for infertility treatment was first introduced into clinical practice in 1950 (2, 3). Subsequently, treatments with urinary FSH have been replaced by recombinant human FSH (rh-FSH), which has been shown to provide several advantages such as absence of…

Pressure Rating for Bioprocess Single-Use Assemblies

Single-use systems (SUSs) are engineered process equipment solutions for pharmaceutical and biologics production. They offer several key advantages, such as lowering energy costs to reduce utility requirements, minimizing cleaning validation efforts, reducing water and chemical use, and enabling flexibility in manufacturing. Use of SUSs is increasingly popular in almost all fields of bioprocess applications (1, 2). SUSs most commonly comprise components made of polymeric materials, which together create a system or unit operation designed for one-time or campaign use. Single-use…

Monitoring Live Biomass in Disposable Bioreactors

Often simply referred to as capacitance, radio-frequency (RF) impedance has been used for over two decades to measure online biomass. It is generally regarded as the most robust and reliable method to monitor live-cell concentrations in mammalian cell culture (1). Many biopharmaceutical companies have now made the transition from conventional glass or stainless steel multiuse (MU) vessels to single-use (SU) bioreactors. Disposables are rapidly becoming the preferred platform for new processes requiring current good manufacturing practice (CGMP) compliance. At the…

Evaluating New Film for Single-Use Bags: Growth Performance Studies with Animal and Human Cells

In biopharmaceutical development and manufacturing processes, single-use technology has become widely accepted (1). Storage and cultivation bags are particularly common. They are fabricated from plastics consisting of multilayer films and are typically provided gamma-sterilized by suppliers (2). The bags offer several advantages such as savings in time and cost. Lowered contamination risk results from reduced cleaning and sterilization demands. However, some adverse effects of polymer films on cell growth and metabolism have been reported, both for storage and cultivation bags…

Special Report: Toward Sustainable Engineering Practices in Biologics Manufacturing

Introduction by William P. Flanagan Biopharmaceutical development and manufacturing demand scalable processes that can be quickly developed, easily implemented, and smoothly transferred to production. Disposable, ready-to-use technologies play a crucial role in providing flexibility to support agile biomanufacturing operations. Single-use systems provide process efficiencies by removing steps such as cleaning and cleaning validation, thus allowing for faster change-over between manufacturing runs. The biopharmaceutical industry is increasingly adopting single-use approaches, and the global market for such bioprocessing tools is expected to…

Advances in Bioprocessing: Single-Use and Stainless Steel Technologies

The increasing penetration of disposable devices in the biopharmaceutical manufacturing industry has been well documented, and with good reason. These applications represent a new paradigm in the evolution of biomanufacturing technologies and practices, opening the industry up to new possibilities such as flexible and modular facilities. But stainless steel applications and innovations remain vital to this industry. Some stainless devices may be irreplaceable, including large tanks, autoclavable and heat-sterilized fermentors and bioreactors, and storage and filling devices. Other innovations in…

Disposable Components in Biomanufacturing: A Regulatory Perspective

On a holistic level, the decision regarding whether to use single-use or stainless steel equipment in a biomanufacturing plant is a significant one. It greatly influences the design, construction, layout, and operation of a plant — and consequently, the timing and cost of the overall project. And regulatory review can add an element of risk to using anything new. Disposables have been viewed as a revolutionary concept, and they are. But from a routine regulatory operational perspective, I believe it…

The Single-Use or Stainless Steel Decision Process: A CDMO Perspective

Decisions regarding whether and when to use single-use (SU) (disposable) devices or stainless steel (SS) equipment for biopharmaceutical manufacturing have been discussed for more than a decade. To date, no argument in terms of safety, cost-effectiveness, or operational efficiency is fully convincing to choose one technology platform or the other for all applications. Biopharmaceutical companies often do not have in-use data to make strategic manufacturing decisions. But one group has been significantly growing its expertise in use of single-use technologies:…

Meeting the Demand for a New Generation of Flexible and Agile Manufacturing Facilities: An Engineering Challenge

Classical stainless steel installations in purpose-built facilities dominate the global capacity for commercial biopharmaceutical manufacturing. Early facilities that were designed for single-product processes are now aging, putting them on the investment radar for upgrades to enable manufacturing diversity, and allow more efficient facility use. More than ever before, global engineering leaders are confronted with complex strategic and financial decisions when they seek to invest capital in new flexible pharmaceutical facilities or flex-grading aging facilities for supply of pipeline products. Manufacturing…

End-User Considerations: How Biopharmaceutical Companies and Their Employees Approach Single-Use and Stainless Steel

Along with the other perspectives offered in this special issue, people tasked with actually implementing and working with single-use, stainless-steel, or the more common variations of hybrid systems deserve a say also. When seeking out end-user comments, however, we should consider both the overall company decisions about which systems to use (decisions that may not have accommodated much input from the manufacturing floor) and opinions from individual scientists, technicians, and process engineers themselves who are presented with the facility design and…