August 2016 August 2016

In recent years, single-use bioreactors have gained more importance in animal and human cell culture. With its new line of BioBLU frigid-wall, stirred-tank, single-use vessels, Eppendorf offers premium solutions for microbial applications. In the following case study, reproducible process control was achieved with parallel-operated BioBLU 0.3f single-use and reusable glass vessels, both used in an Eppendorf DASbox® mini bioreactor system. Fermentation of Escherichia coli K12 led to very comparable results, thus proving tested single-use vessels to be an appropriate tool to accelerate microbial process development and shorten time-to-market in all industries related to microbial production processes. BioBLU of 0.3f single-use vessel (left) and DASbox mini bioreactor (right) IntroductIon Single-use bioreactors are a suitable tool for time- and cost-effective bioprocessing. Minimized setup times, eliminated cleaning procedures, and reduced labor time can sustainably accelerate bioprocess development. In ...

Single-use technology has transformed the biomanufacturing industry, because single-use products provide significant savings over stainless steel infrastructure. Single-use technologies also create flexibility for biomanufacturers, enabling them to move from single-product processes to multiproduct facilities. As revolutionary and transformative as single-use technologies have been, the industry is on the cusp of another major shift, which comes with its own impressive benefits, but with some challenges as well. Continuous and Batch Processing Continuous processing has been used successfully for many years in a number of manufacturing industries such as in the production of food, chemicals, and steel. When applied to biomanufacturing and combined with single-use technology, continuous processing can offer much higher throughput and increased flexibility. Batch processing has been the logical method in biomanufacturing for regulatory compliance and quality control. The batch method establishes clear bounda...

Fast and accurate determination of vaccine titer during manufacturing is important for understanding the performance of a development process and for scaling each process step. Although single radial immunodiffusion (SRID) has been the most commonly used technique for vaccine titer determination, it can be time-consuming and imprecise, requiring up to three days for results. The Pall ForteBio Octet® system offers a simple and direct method for measuring vaccine–antigen–antibody binding, capable of delivering high-precision analysis in as little as three hours. Table 1: Comparison of Octet system with single radial immunodiffusion (SRID); B/Massachusetts influenza virus Methods Using the influenza virus as a model system, the relative standard deviation and dynamic range of a vaccine titer assay were measured with the Octet system and compared with results from using SRID. Polyclonal serum antibodies were loaded onto Octet biosensors, and their binding measured to epitopes presented by an inactivated virus...

Efficient expression of proteins is an integral part of the biopharmaceutical drug development process. With a range of expression systems, it is important to balance long-term manufacturing goals (e.g., cost of goods and productivity) while matching the expression system to suit the characteristics of a protein (e.g., product quality attributes and long-term stability). Finding the right expression system early on can make or break a therapeutic candidate as it moves from laboratory bench to clinical administration. FUJIFILM Diosynth Biotechnologies has developed its pAVEway™ expression technology to support microbial expression of proteins. This platform technology incorporates three elements in the delivery of an Escherichia coli expression process: optimized expression vectors and control elements, preselected host strains, and platform development using a high-throughput approach for fast strain selection and/or design of experiment (DoE) approaches. DNA looping in pAVEway™ expression technology is...

Today algae are commercially cultivated for pharmaceuticals, nutraceuticals, cosmetics, and aquaculture purposes.  The abundance of vitamins, minerals, and trace elements as well as the fatty acid profile and thickening and stabilizing functions of their polysaccharides make algae valuable. Algae also can be used to produce biodiesel, bioethanol, and biomass that can be burned to generate heat and electricity. Like plants, algae use sunlight during photosynthesis. Photosynthesis is an important biochemical process in which plants, algae, and some bacteria convert the energy of sunlight to chemical energy. Algae capture light energy through photosynthesis and convert inorganic substances such as CO 2 into simple sugars or oils using the captured energy. KIT laboratory Several factors (e.g., light, temperature, pH, nutrients, aeration, and mixing rate) can be measured to determine the growth rate of algae. To optimize yield, algae is cultivated in closed photobioreactors. Within those, process conditions c...

Many biopharmaceutical manufacturers are implementing single-use containment for transfer of media and buffer materials to prevent feedstock contamination and promote worker safety. But the type of containment system used can have a significant impact on productivity and profitability. Equipment should be evaluated and chosen carefully. Pertinent Questions Systems should be analyzed not only for their basic ability to contain powders of interest, but also for how efficiently they integrate into production process. For instance, could the system introduce productivity bottlenecks, increase material waste and the cost of raw materials, or complicate changeover of a line to new products? Is it robust enough to provide reliable transfer throughout the production run? And has it been designed specifically to contain and release powders? The answers to those questions are crucial to identifying and implementing a sound powder-transfer system. Issues of Powder Handling Media and buffer ingredients used in powd...

The need for a rapid turn-around in quantity (and the loss of technicians in many laboratories) has created a trend toward implementation of single-use vessels. Their advantages include no time lost in cleaning or sterilization (especially for bench-scale, autoclavable systems), no chance of inhibition or cross-contamination due to poor cleaning, and no need for cleaning and sterilization facilities in a crowded laboratory. For production-scale steel bioreactors, fully automated clean-in-place (CIP) and sterilization-in-place (SIP) have been possible for decades. By contrast, bench-scale systems required considerable downtime for disassembly, cleaning, reassembly, autoclaving, and cooling before use — with no guarantee that each step was carried out correctly and reproducibly. An innovation from INFORS HT brings the advantages of CIP/SIP to bench-scale bioreactors, offering a true alternative to single-use systems for microbial applications. Table 1: Sterility testing against a panel of highly resistant t...

For over 75 years, Kerry has earned its reputation for reliability and excellence in serving the biotechnology, pharmaceutical, and nutrition markets. We deliver innovative solutions to assist customers increase cell proliferation, extend cell viability, and increase target protein production in biotechnological production systems. Figure 1: Viable cell density and IgG titer in CHO DG44 cell line Every day, we expand our capabilities to meet the changing needs of the biotechnology market. Kerry’s products have evolved with market trends in cell culture over the past 50 years to fulfill our customers’ requirements and have grown to encompass modern plant-based hydrolysates, yeast extracts, recombinant proteins, cell-line–tailored supplement systems, and chemically defined media. Kerry has the vast global resources and technical platform to deliver consistent, high-quality products backed by unparalleled service, technical support, and formulation customization capabilities. Chinese hamster ovary (CHO) cell...