« INDUSTRY NEWS
1000L bioreactors, with a 2000L bioreactor already planned for 2014. The facility has been designed for rapid
further expansion to
meet customer demand. The company is already working on its fi rst customer project for the facility.
This new capacity is the latest in a series of investments at both Fujifi lm Diosynth Biotechnologies’ UK and Research Triangle Park, NC, USA facilities totalling £30m over the last two years. New cell line development and process development laboratories have been set up at both sites, and a 1000L single-use bioreactor was installed at the RTP facility two years ago to supplement its 2000L stainless steel train for the GMP production of mammalian cell culture biopharmaceuticals.
Steve Bagshaw, Managing Director of Fujifilm Diosynth Biotechnologies UK Limited said, “This new capacity, using the latest single-use technologies, provides our customers with a full life-cycle offering for mammalian cell culture biopharmaceuticals from our UK site, and complements our offering in microbial- based biologics. It reinforces Fujifilm’s commitment to lead the global Biologics CMO industry through continuous innovation and implementation of new technologies.”
SAFC® Strengthens Biopharmaceutical Position with Innovations to Established CHOZN® Portfolio
Sigma-Aldrich Corporation announced that SAFC® Commercial, its custom manufacturing services business unit, has engineered additional traits into its CHOZN® Platform cell line, increasing the utility of the CHOZN® portfolio of products and services.
Two novel host cell lines have been added to the CHOZN® portfolio, yielded through SAFC’s continuous research and development. The fi rst of these lines is the CHOZN® GS-/- host trait stacked with a knockout of the MGAT1 gene function that results in early termination of the N-glycan pathway and enables the expression of recombinant proteins with homogeneous high Man5 glycan profi les. This is useful for protein crystallography studies as well as for the expression of biotherapeutics that target mannose receptors.
The second novel cell line is the CHOZN® GS-/- host trait stacked with knockouts of the CMAH and GGTA gene sequences. The knockout of the function of these two genes enables the expression of recombinant proteins that do not contain the antigenic alpha-gal and Neu5Gc moieties on the glycan structures and makes them capable of producing potentially safer therapeutic proteins. These two newly engineered CHO host cells, as well as the parental CHO-K1 cell line, are now commercially available from SAFC® as custom products.
“The additional traits and unique combination of the CHOZN® platform and media/feed optimization services provide a best-in-class off er, with continuous advances to the customer,” said Kevin Gutshall, Senior Manager for Marketing and Commercial Licensing. “SAFC’s CHOZN® Portfolio, in combination with Sigma-Aldrich’s robust intellectual property on the Zinc Finger Nuclease (ZFN) technology, provides CHOZN® customers with a seamless gateway from development through commercialization.”
The CHOZN® portfolio consists of the CHOZN® Platform, additional CHOZN® ZFN-modifi ed cell lines, ZFN reagents, and customization options including cell line and media development projects.
EMD Millipore Launches Eshmuno® A Chromatography Media and Chromabolt™ Prepacked Columns
EMD Millipore, the Life Science division of Merck KGaA, Darmstadt, Germany, introduced two additions to the Company’s comprehensive chromatography portfolio to further accelerate downstream purifi cation and improve process effi ciency.
Eshmuno® A is a rigid, high capacity, acid and alkaline resistant Protein A affi nity chromatography media for the purifi cation of monoclonal antibodies and other Fc-containing proteins. Higher binding capacities off ered by Eshmuno® A media in comparison with other commercially available Protein A media delivers increased productivity and lower costs.
Chromabolt™ prepacked, pre-validated chromatography columns, available with a range of EMD Millipore chromatography resins, are designed for early clinical stage manufacturing. Pre-validation indicates the columns meet bioburden, endotoxin, HETP and asymmetry pecifi cation for the resin. Off ered in 3 sizes – 10, 20 and 32 cm i.d. – Chromabolt™ prepacked columns eliminate laborious packing and equipment cleaning. The columns are currently available packed with Fractogel® SO3, Fractogel® TMAE HiCap, and Eshmuno® S resins. Going forward, additional resins will be made available in the Chromabolt™ format.
The prepacked columns are compatible with all currently available chromatography systems and connectors, have easily accessible inlets and outlets, and off er faster set-up times compared to traditional columns. Ergonomic and easily transportable by a single person, the 20 cm and 32 cm sizes are on wheels.
Shimadzu Launches Next Generation FTIR Spectrophotometer T at Provides Exceptional Speed, Sensitivity and Resolution
Answering the need for increased speed and accuracy in infrared analysis, Shimadzu Scientifi c Instruments Inc. has introduced the IRTracer-100 Fourier Transform Infrared (FTIR) spectrophotometer. Combining high speed, sensitivity and resolution with enhanced expandability and easy-to-use software, the IRTracer-100 quickly and easily obtains high-quality data for samples.
The IRTracer-100 off ers best-in-class 60,000:1 S/N ratio, which allows researchers to quickly and easily obtain high-quality data of ultra- small contaminants. Resolution of 0.25 cm-1 provides for highly
www.americanpharmaceuticalreview.com | | 115
»
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20 |
Page 21 |
Page 22 |
Page 23 |
Page 24 |
Page 25 |
Page 26 |
Page 27 |
Page 28 |
Page 29 |
Page 30 |
Page 31 |
Page 32 |
Page 33 |
Page 34 |
Page 35 |
Page 36 |
Page 37 |
Page 38 |
Page 39 |
Page 40 |
Page 41 |
Page 42 |
Page 43 |
Page 44 |
Page 45 |
Page 46 |
Page 47 |
Page 48 |
Page 49 |
Page 50 |
Page 51 |
Page 52 |
Page 53 |
Page 54 |
Page 55 |
Page 56 |
Page 57 |
Page 58 |
Page 59 |
Page 60 |
Page 61 |
Page 62 |
Page 63 |
Page 64 |
Page 65 |
Page 66 |
Page 67 |
Page 68 |
Page 69 |
Page 70 |
Page 71 |
Page 72 |
Page 73 |
Page 74 |
Page 75 |
Page 76 |
Page 77 |
Page 78 |
Page 79 |
Page 80 |
Page 81 |
Page 82 |
Page 83 |
Page 84 |
Page 85 |
Page 86 |
Page 87 |
Page 88 |
Page 89 |
Page 90 |
Page 91 |
Page 92 |
Page 93 |
Page 94 |
Page 95 |
Page 96 |
Page 97 |
Page 98 |
Page 99 |
Page 100 |
Page 101 |
Page 102 |
Page 103 |
Page 104 |
Page 105 |
Page 106 |
Page 107 |
Page 108 |
Page 109 |
Page 110 |
Page 111 |
Page 112 |
Page 113 |
Page 114 |
Page 115 |
Page 116 |
Page 117 |
Page 118 |
Page 119 |
Page 120 |
Page 121 |
Page 122 |
Page 123 |
Page 124 |
Page 125 |
Page 126 |
Page 127 |
Page 128 |
Page 129 |
Page 130 |
Page 131 |
Page 132 |
Page 133 |
Page 134 |
Page 135 |
Page 136 |
Page 137 |
Page 138 |
Page 139 |
Page 140 |
Page 141 |
Page 142 |
Page 143 |
Page 144 |
Page 145 |
Page 146 |
Page 147 |
Page 148 |
Page 149 |
Page 150 |
Page 151 |
Page 152 |
Page 153 |
Page 154 |
Page 155 |
Page 156