Single Use

Trends in Setting Single-Use Technology Standards

The biopharmaceutical industry now incorporates single-use (SU) technology and systems in most production processes based on cell culture (1, 2). Implementation of such technologies has led to the availability of prepackaged and sterilized systems complete and ready for use with preinstalled mixers and monitoring probes. From upstream process- material preparation through final-product formulation, biopharmaceutical sponsors are increasingly presented with numerous SU solutions that support all major production platforms (3–5). The number of SU materials and suppliers in biopharmaceutical manufacturing has…

Integrated Optical Single-Use Sensors: Moving Toward a True Single-Use Factory for Biologics and Vaccine Production

Through the past decade, single-use bioreactors for culturing mammalian and insect cells have been widely adopted in preclinical, clinical, and production-scale biopharmaceutical facilities (1, 2). With such bioreactors in operation, monitoring and control of process parameters is vital for ensuring critical quality attributes (CQAs) of biologicals or vaccines are met for production of a safe product. Traditionally, bag-based and bench-top vessels have been fitted with conventional pH and dissolved oxygen (DO) probes similar to those used in stainless steel or…

Designing Single-Use Solutions for the Future: A Conversation with Christel Fenge

Recently, BPI publisher Brian Caine and editor in chief Anne Montgomery had the opportunity to talk with Christel Fenge, Sartorius Stedim’s VP of marketing for fermentation technologies, in the Göttingen, Germany, Sartorius facility. They began by talking about fermentation technology, a topic that led them to touch upon a number of key issues in the biopharmaceutical industry. Fermentation Technology Caine: Because this special issue focuses on fermentation technology, let’s begin by talking about some recent technological improvements and what impact…

Robust and Convenient Single-Use Processing: The Superior Strength and Flexibility of Flexsafe Bags

With the increased use of disposable bioprocessing bags in all critical process steps of the biopharmaceutical drug production, there is a growing requirement for high-quality, robust, and easy-to-handle bioprocessing bags. The new generation of films and bags must combine multiple mechanical, physical, and chemical properties to make these products suitable and scalable for all processing steps in upstream, downstream, and final filling operations, including cell culture in rocking motion and/or stirred-tank, single-use bioreactors as well as storage, mixing, shipping, and…

Enhanced Assurance of Supply for Single-Use Bags: Based on Material Science, Quality By Design, and Partnership with Suppliers

Growing adoption of single-use bags in commercial production of biopharmaceutical drugs raises new challenges for bag suppliers and drives the need for consistent product quality, improved assurance of supply, robust change management, and business continuity planning. In close collaboration with resin and film suppliers, polymer scientists and biologists at Sartorius Stedim Biotech have followed a stringent material science and quality by design (QbD) program to develop a completely new polyethylene film and to achieve consistent performance of new Flexsafe bags…

Total Solutions Support the Growth of a Dynamic Industry: A Conversation with Reinhard Vogt and Stefan Schlack

While attending a conference at Sartorius Stedim Biotech in Göttingen, Germany, BPI publisher Brian Caine and editor in chief Anne Montgomery spoke with Reinhard Vogt (executive vice president of marketing sales and services, and member of the administrative board) and Stefan Schlack (senior vice president, marketing and product management). They discussed Sartorius’s forward-thinking business strategies, its position as a total solution provider, and how the company’s strategic goals mesh with its assessment of current industry directions. Single-Use As an Enabling…

Disposables for Biomanufacturing: A User’s Perspective

The supply scenario for many biopharmaceutical drugs such as monoclonal antibodies (MAbs) is changing. With the implementation of personalized medicine resulting in drugs for specific, high-responder subsets of patients, market volume per drug will decrease. In addition, increasing fermentation titers of up to 10 g/L for MAbs are leading to smaller fermentation volumes necessary to accommodate individual biopharmaceutical market demands. That results in approaches such as flexible production in campaigns or decentralization of manufacturing using similar facilities with low risk…

BPI Theater at the 2014 BIO Convention

When we launched the BioProcess Theater series at the Biotechnology Industry Organization’s International Convention in 2007, we hoped that our special programming would fill a need within that event’s exhibit hall. We wanted to bring into the hall the type of technical presentations that are not generally part of the main event’s more executive-level, business-focused programming.It has therefore been especially gratifying to see our attendance growing every year — such that standing-room-only is becoming more the rule than the exception.…

Biopharma Unhappy with Suppliers’ Progress on Single-Use Hookups

Single-use equipment vendors are failing to meet their biomanufacturing customers’ expectations in several key areas, according to BioPlan Associates’ 11th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production (1). The study — based on a global survey of 238 global biomanufacturers and contract manufacturing organizations, as well as 158 vendors and suppliers in 30 countries — identifies significant gaps between the perceived importance of key vendor attributes and companies’ satisfaction with their vendors regarding those attributes. One area…

Industry Experts Convene in New York to Discuss Latest Innovations: A BPI Special Report

As the biopharmaceutical industry continues to mature and grow, so too does the need to educate a broader audience of biopharmaceutical professionals interested in hearing, understanding, and applying the latest science and technology trends that support and in many cases are transforming today’s bioprocesses. To reach this extended and engaged audience, BioProcess International created the BPI Theater Series: a live, interactive program that provides bioprocessing content to traditional, noncore biopharmaceutical conference programs. It provides attendees with the opportunity to interact…