August 2013

Presenting Sustainable Fluid Handling

Picture the scene: You head to the boardroom for a meeting with a vendor who promises to optimize your company’s fluid-handling processes. “Sustainability,” he says, enshrined in the spotlight of an overhead projector, “is at the heart of today’s agenda.” You slump into your chair. Sustainability is key to your business, yet efforts to bottle this elusive ideal have so far cost more than they’ve saved. “How can a sustainable bioprocess container solution enhance my business?” you ask. “It’s about…

Enhanced Capture of a Recombinant Human Growth Factor Using Eshmuno® CPX Resin

Eshmuno® CPX resin is a new strong cation exchanger developed using EMD Millipore’s tentacle technology to provide high binding capacity, resolution, and target yield. For process improvement purposes, this resin was applied for capture of rhFGF18, a fibroblast growth factor (expressed in Escherichia coli) in phase 2 clinical development for restoring damaged cartilage surface in osteoarthritis. Early purification work used Resin A at low load (12.3 mg target/mL CV) and moderate flow rate (180 cm/h = 6.7 min residence time,…

Commercial Prefilled Syringe Filling

The commercial prefilled syringe line at Cook Pharmica can process up to 600 syringes per minute, 36,000 syringes per hour, or 70 million syringes per year. The automated, high-speed syringe line is fully enclosed in a barrier isolator to provide the highest level of aseptic processing available by removing the human element from the entire process. With the ability to operate in smaller batches or full-scale campaigning, the prefilled syringe line is capable of bridging clinical programs into commercial production.…

A New Generation of Generic HCP Assays

Host-cell protein (HCP) analysis is a big issue when it comes to early clinical testing, design of downstream processes, and quality control of biopharmaceuticals. The decision to use an off-the-shelf generic HCP assay or spend a considerable amount of money for development of a specific HCP assay is often not an easy one. In theory, generic HCP assays should be suitable for all HCP determinations of a specific cell line — independent of cell line modifications, fermentation conditions, and the…

The RAMbio Incubator Improves Culture Growth and Protein Expression

End oxygen limitations when growing Escherichia coli, Streptomyces, Pichia, Aspergillus, and other high-demand aerobes in shake flasks. Many bioprocesses rely on aerobic growth and protein expression, yet traditional orbital shakers do not provide adequate oxygen. Cultures become oxygen limited. The RAMbio incubator solves this problem by providing active headspace refreshment using low-frequency acoustic energy that aerates standard shake flasks. Why Use the RAMbio? The increased dissolved oxygen provided by the RAMbio may benefit aerobic microbial cultures by Increasing biomass, protein,…

Polishing a Monoclonal Antibody (MAb) Using Capto™ adhere ImpRes in Bind and Elute Mode

A platform approach for MAb purification is desirable as it saves both time and money in process development. GE Healthcare Life Sciences’ MAb toolbox employs protein A chromatography media (resins) as well as a wide range of options for polishing purification steps. One of these options is Capto adhere ImpRes, a cost-effective and flexible multimodal anion exchange chromatography medium designed for high-resolution polishing of MAbs. The medium allows operation in either bind-elute (B/E) or flow-through (FT) modes. Here we describe…

Scale-Up of Human Mesenchymal Stem Cells on Microcarriers in Suspension in Single-Use Bioreactors

Mesenchymal stem cells (MSCs) are an attractive target for clinical study as therapeutic agents. However, current multilayer flatbed culture-expansion paradigms are cumbersome, time consuming, and typically limited in the ability to monitor cell characteristics during the growth process. We have used the Mobius® CellReady 3-L bioreactor in combination with microcarriers and human mesenchymal stem cells (hMSC) as a model. Following expansion, we have comprehensively compared the characteristics of cells grown in the bioreactor with those grown in standard two-dimensional (2D)…

4 New Viral Clearance Suites, 4 Service Models, All 4 You

Flexibility has been the key driving force behind the success and growth of Eurofins Lancaster Laboratories’ viral clearance program. “When we introduced four levels of service solutions for viral clearance studies, our clients responded well,” says Dr. Kate Bergmann, manager of viral safety and clearance. “They appreciate that we can tailor our program to meet their specific needs. They can use any of our service levels to address all their scientific, safety and scheduling challenges.” To provide additional capacity, the…

Biopharmaceutical Product Development

Catalent is your strategic partner for biologic drug development success. We create smart, tailored solutions with our novel SMARTag™ antibody–drug conjugation (ADC) technology, our market-leading GPEx® cell line expression system, expanded biomanufacturing capabilities, and integrated development services to help you get better products to market faster. New SMARTag ADC Technology for Development of Optimized Antibody–Drug Conjugates — Superior Technology for Treatments in Development: Catalent has entered into an exclusive license and comarketing agreement with Redwood Bioscience to offer customers SMARTag…

Downstream Scale-Up Purification of Influenza Virus Using ReadyToProcess™ Equipment

The vaccine manufacturing industry is continuously seeking more flexible and time-saving solutions for a quicker response to pandemic outbreaks (1, 2). For influenza, vaccine is traditionally produced in fertilized hen eggs and purified in fixed steel equipment. Here we describe the scale-up of a downstream purification process of cell-based influenza virus, from a 10 L cell culture to the purification from a 50 L culture using ReadyToProcess single-use technology. Single-use technology reduces the need for time-consuming device preparations, such as…