Recent trends in biomanufacturing technology and the biopharmaceutical market are driving the increased adoption of single-use (SU) manufacturing systems. From the demand side, the biopharmaceutical industry’s focus on niche and rare diseases with relatively small patient populations is pushing for smaller, more flexible biomanufacturing capacities than have been needed in the past. The entry of many companies into biosimilars development also is leading to fragmentation and dispersion of manufacturing capacity. Changes on the supply side caused by technological advances have…
April 2014 Supplement
Establishing Single-Use Assemblies on Filling Equipment
Biotest is a worldwide-operating company specializing in innovative hematology and immunology products with the holistic approach of a global pharmaceutical and biotherapeutics group. The company’s products are used to treat life-threatening diseases such as coagulation disorders (hemophilia), severe infections, and disorders of the immune system. The most important starting material for Biotest’s pharmaceutical products is human blood plasma, which is processed into medicinal products at a production facility in Dreieich, Germany. The company has explored using single-use assemblies as part…
High–Cell-Density Clarification By Single-Use Diatomaceous Earth Filtration
Single-use concepts are widespread in all unit operations of the biopharmaceutical industry. Although single-use technology is rapidly advancing and considered to be highly advantageous in many regards (1,2,3), in some cases it cannot (yet) compete with classical manufacturing systems. Processes with a demanding character (e.g., high cell densities, high titers, high turbidities, increased particle/contaminant loads) especially can bring disposables to their limit of technical feasibility, especially in product harvesting (4,5,6). Here we focus on that step, which is defined as…
Comparing Multiuse and Single-Use Bioreactors for Virus Production
In the past decade, single-use bioreactors gained significant importance in manufacturing processes of monoclonal antibodies (MAbs) and recombinant proteins. The success of such technologies comes from their numerous advantages over multiuse equipment (1). Overall, disposables offer an answer to some key challenges in the biopharmaceutical industry: time to market, validation complexity, process security, production efficiency, and cost of goods. Because the same challenges apply to vaccine production, single-use bioreactors also have the potential to optimize manufacturing processes and offer further…
Understanding Particulates in Single-Use Bags
The biopharmaceutical industry is facing many challenges. Global economic changes, increasing healthcare costs, expiring patents, and increasingly personalized medicine all affect the way manufacturers approach bioprocessing steps and the equipment and systems used to make biological drug products (1). Demands for smaller batch sizes, greater process flexibility, reduced manufacturing costs, and increased speed to clinic have driven the acceptance of single-use systems (SUSs) in this industry (Figure 1). SUS suppliers have rapidly developed components such as fittings, tubing, pumps, sensors,…
Efforts Toward the Harmonization of Single-Use Standards
During the 2013 BioProcess Conference and Exhibition, in Boston, MA, BPI held a town hall on single-use standardizations and best practices. The purpose was to update attendees on the current status of standardization and harmonization of single-use systems from the perspectives of a number of user groups and discuss the approach of each organization to such efforts. James D. Vogel, founder and director of The BioProcess Institute, moderated a panel of representatives from the Parenteral Drug Association (PDA), the International…
How Plastics Are Made
The term plastics includes materials composed of various elements such as carbon, hydrogen, oxygen, nitrogen, chlorine, and sulfur. Plastics typically have high molecular weight, meaning that each molecule can have thousands of atoms bound together. Naturally occurring materials, such as wood, horn, and rosin, are also composed of molecules of high molecular weight. Manufactured or synthetic plastics are often designed to mimic the properties of natural materials. In fact, some of the earliest plastics were developed to replace scarce natural…
Single-Use and Sustainability
What is sustainability? For some people, the special meaning of the word in an environmental context is how biological systems remain diverse and productive over time. Thus, sustainability is not just about saving resources or preventing pollution within a narrow context; it's more a long-term holistic approach to ecologically relevant activities. For other people, the term includes all environmental concerns, including those of immediate and/or nonbiological nature. Examples of such issues might involve a town's solid-waste disposal system or a…