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Flavivirus Vaccine Production Accelerates with Modern Bioprocess Tools and Solutions

As with all viral vaccines, the complex nature of flaviviruses makes process development technically challenging. In addition, vaccine production can be both costly and difficult to scale to meet market demands. In egg-based vaccine production, for example, 100–300 vaccine doses can be produced from one fertilized hen’s egg. However, the eggs used for production need to be supplied from special pathogen-free chicken flocks, limiting availability of eggs and making vaccine production difficult to scale up. To meet the needs of…

Pfizer Collaborates to Accelerate Approval of Biosimilar MAbs in China

In their pursuit of developing therapeutics, biopharmaceutical companies face many challenges, including pressure to meet aggressive timelines, reduce risk and cost, and increase speed to market. Addressing these challenges is especially critical for biosimilar manufacturers, who face fierce competition and an expanding footprint in emerging markets (1). The global biosimilars market is growing rapidly and is expected to exceed more than US$6 billion by 2020 (2). This case study describes how Pfizer is collaborating with GE Healthcare to achieve regulatory…

Roivant Sciences Accelerates Process Development to Speed Orphan Therapy to Market

Although the demographic of orphan therapies is small, making therapies for rare diseases available has a huge impact for the affected patients. Cooperation to expand capacity end expertise during process development and manufacturing for preclinical and clinical phase studies is one way to increase speed to market. This case study shares the work of GE’s Fast Trak Services team to help accelerate development of a process for cGMP production of material for toxicology studies. Frequent communication between the Fast Trak…

MAbxience Optimizes and Accelerates Downstream Biosimilar Process Development

Biosimilars represent an innovative solution that can benefit both patients and healthcare systems by reducing the burden of rising treatment costs. To improve the availability, price, and access of medicines, many countries are implementing strategies to establish their own production capacity. To support such development, MAbxience (a Spanish biotechnology company specialized in research, development, and manufacture of biosimilar drugs) is committed to provide the manufacturing of high-quality products and processes that meet regulatory and technical requirements in all countries where…

An Introduction to the FUTURA pico for Mini-bioreactors

Small bioreactors are gaining share in process development laboratories. It is vital that these bioreactors are realistic scale down models of larger systems and it is equally important that online sensors for measuring live biomass can also be used in these vessels. ABER, known and trusted for its sensors that measure live cell concentrations using capacitance technology and adopted in the world’s leading bio pharmaceutical companies from R&D through to cGMP processes brings you the new FUTURA PICO. Our Conventional…

µPAC™ Microchip Chromatography: Better By Design

The boundaries of technology can be pushed significantly when insights from different fields reinforce each other. Based on in silico simulations demonstrating the importance of order on the efficiency of chromatographic separations, PharmaFluidics has combined expertise from the analytical chromatography and semiconductor chip manufacturing industries to create a new type of nanoscale liquid chromatography (LC) column. Conventional LC columns contain randomly packed beads as a stationary phase. By contrast, PharmaFluidics uses a lithographic etching process to create a perfectly ordered…

Single-Use Automation: Unlocking the True Potential of Single-Use Technology

When single-use technology first arrived on the scene in the late nineties, the processes that it was applied to were relatively simple and low risk. These included simple filtration and storage applications of buffers and cleaning solutions. With these filtration steps typically involving lower value, non-blocking solutions of easy to dissolve salts, automation would have been seen as an unnecessary over- complication. It was thought sufficient to have an operator watch the process to make sure nothing became disconnected, a…

Ask the Expert: Purification of Antibody Fragments Using Amsphere A3 Protein A Resin

In an “Ask the Expert” webinar on 13 September 2017, Gerald Platteau of JSR Life Sciences described the use of Amsphere A3 resin to purify antibody fragments. He explained the molecular binding mechanism for VHH singledomain antibodies and compared dynamic binding capacity (DBC) data with those of other affinity resins. Platteau’s Presentation For full-size monoclonal antibodies (MAbs), the standard capture step is based on protein A. Its binding to the Fc region has been well described as taking place at…

Ask the Expert: Single-Use Bag Permeability Testing in Cryopreservation Conditions

In BPI’s “Ask the Expert” webcast on 4 October 2017, Mike Johnson (market development manager at Entegris Life Sciences) discussed single-use bags and gas permeation. Johnson’s Presentation Permeation rates are a function of fluid properties, the type of material being penetrated, and application temperature. Standardized test methods used to determine permeability characteristics include ASTM D1434 and ASTM D3985. A fixture in Entegris’s test apparatus holds a sample plaque that is flanked upstream by high-pressure gas and downstream by a sensor…

Isolator advantages in Cell Therapy Production

With numerous cellular and gene therapy products seeing strong initial clinical successes, investment in next-generation technologies by both large bio/pharma companies and start-up specialist firms has been significant. In fact more than 750 companies worldwide declare themselves to be in the “regenerative medicine” market space, with a high percentage of year on year increases in the number of cellular and gene therapy drugs in clinical trials. Many of these companies are eager to advance from early stage clinical trials to…