This special issue has come about through a long collaborative process with our contacts at Sartorius Stedim Biotech in Göttingen, Germany. It is the third such sponsored issue that BPI has published over the years with the company and the first one that we have produced in-house. We could not be happier with the results. The aim here is to highlight technologies and responses to key industry challenges rather than focus over much on Sartorius itself. But the company’s long-standing…
Tuesday, September 23, 2014 Daily Archives
Automated Mini Bioreactor Technology for Microbial and Mammalian Cell Culture: Flexible Strategy to Optimize Early Process Development of Biologics and Vaccines
The use of mammalian and microbial cells in the production of biologics and vaccines is well established, and the majority of the top 10 drugs are now manufactured in this way. There is a significant and growing pipeline of new biologics (1), which in combination with increased pressure on cost reduction and generic competition from biosimilars (2), means that many biopharmaceutical companies are looking for ways to improve productivity in their development laboratories to ensure that upstream processes are efficient…
Single-Use, Stirred-Tank Bioreactors: Efficient Tools for Process Development and Characterization
During the past decade, single-use bioreactors have become widely accepted as an alternative to conventional stainless steel or glass bioreactors for clinical manufacturing and process development. In the biopharmaceutical industry, glass bioreactors are used mainly for process development and optimization, but also scale-down models for process characterization. So it is of significant importance that such vessels replicate the design of production-scale bioreactors for both reusable and single-use applications. Stirred-tank bioreactors with 2-L, 5-L, and 10-L working volumes have proven to…
Design of Experiments with Small-Scale Bioreactor Systems: Efficient Bioprocess Development and Optimization
Design of experiments (DoE) is one of the most valuable techniques for organized and efficient planning, execution, and statistical evaluation of experiments. Although a DoE investigation can be completed using several runs in one bioreactor, small-scale bioreactor systems designed for parallel operation (such as the ambr15 or ambr250 systems) provide the optimal basis to economically realize a series of experiments. Because of the multitude of interdependent parameters involved in applications such as cell line development, culture media screening, and the…
Superior Scalability of Single-Use Bioreactors
During the past several years, single-use bioreactors have been gradually established in modern biopharmaceutical processes (1, 2). This adoption is directly linked to their unique ability to enhance flexibility and reduce investment and operational costs. Furthermore, production output can be increased, and time to market is shortened (3). Today a wide variety of single-use bioreactors exists for the cultivation of mammalian and insect cells (4), whereas only limited solutions are available for microbial cultures (5). Typically, processes are established and…
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…
Diatomaceous Earth Filtration: Innovative Single-Use Concepts for Clarification of High-Density Mammalian Cell Cultures
In the past decade, biopharmaceutical manufacturers have demonstrated major improvements in monoclonal antibody (MAb) production, exhibiting product titers frequently in the range of 5–10 g/L using standard fed-batch mammalian cell cultures (1, 2). Increased product yields allow for smaller-scale production vessels. With 2,000-L single-use bioreactors already commercially available, single-use manufacturing of biomolecules becomes more and more an option. Other recent developments in the biopharmaceutical industry — e.g., drugs for smaller indications and more potent drugs allowing for lower dosages —…
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…
Consistently Superior Cell Growth: Achieved with New Polyethylene Film Formulation
During the past decade, single-use bioprocessing bags and bioreactors have gained a significant foothold in the biopharmaceutical industry because they offer a number of advantages over traditional stainless steel equipment, especially for clinical production, multiproduct facilities, and emerging economies. At the same time, some companies are concerned that plastic materials might release potentially toxic substances that could affect cell growth and product titers (1). In a worst-case scenario, they could even compromise drug safety when a company uses disposable bags…
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…