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 resulted in higher titers and enhanced specificity, again driving the industry toward smaller production systems. Furthermore, there has been increased outsourcing of manufacturing activities to contract manufacturing organizations (CMOs) whose multiproduct facilities have been the earliest adopters of SU technologies (
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The benefits of SU technologies have been recounted in a multitude of articles and publications. Despite this ...
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 of an effective manufacturing strategy.
Single-use assemblies provide major advantages during clinical supply filling, when timing can be critical. A company can experience cost and time savings by eliminating cleaning and sterilization validations from project lead-in time. Some time-consuming cleaning and sterilization steps are not required because sterile single-use assemblies are used directly, allowing for signi...
+4Single-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 (
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,
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,
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), 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 (
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,
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,
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).
Here we focus on that step, which is defined as a removal of cells, debris, and (ideally) typical contaminants such as host-cell proteins (HCPs) and DNA from process fluid. In conventional (multiuse) facilities, a typical harvest is a multistep procedure:
To perform similar tasks in a single-use facility, different approaches have been necessary because single-use centrifuges were not available until only recently. The most convenient way was to replace the centrifug...
+2 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 benefits to the animal vaccine industry. Vaccine manufacturers require great flexibility in their production equipment because they typically produce several different vaccines at reduced volumes using a number of cell lines. That need is particularly important to animal-health companies that manufacture not only different antigens, but also antigens for different target species. The enhanced flexibility o...
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, and flexible containers that are delivered to users presterilized and ready for use in single campaigns or process steps.
Applications such as buffer preparation and media storage were the first to adopt single-use components including filter capsules and plastic biocontainers. As single-use technology became accepted, it moved into upstream processes with the implementation of disposable bioreactors and mixing sys...
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 Society for Pharmaceutical Engineering (ISPE), American Society of Mechanical Engineers-BioProcessing Equipment (ASME-BPE), the BioPhorum Operations Group (BPOG), and the Bio-Process Systems Alliance (BPSA). Here are the highlights of that forum.
Vogel started by addressing the fundamental questions: “Where is single-use right now? Where is the collective thinking, and where do we all want this to go? What we do know today is that it's a very competitive industry. Titers are up, b...
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 polymeric materials such as ivory. As billiards grew in popularity through the 1880s, the cost of ivory billiard balls increased. So a challenge went out to develop a synthetic alternative. John Wesley Hyatt invented a plastic alternative to ivory for billiard balls in 1869 called nitrocellulose (US patent 50359, the first American patent for billiard balls). It became the commercial Celluloid brand in 1870.
Plastics (
polymers
) are produced by conversion of monom...
