FROM THE EDITOR

What Is the Industry Underestimating About An ADC Supply Chain? – Part 2

In this article, Dan Bell, vice president of regulatory compliance and technical affairs for Marken, discusses regulatory challenges, and both he and Nathan Ihle, Ph.D., VP of CMC Strategy and Management at Seattle Genetics, offer best practices to apply when planning your ADC supply chain.

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BIOPROCESS INSIGHT

  • Application Of The Finesse Glass Bioreactor For Fermentation Of Saccharomyces Cerevisiae
    Application Of The Finesse Glass Bioreactor For Fermentation Of Saccharomyces Cerevisiae

    This application note describes the cultivation of Saccharomyces cerevisiae cells in the Finesse glass vessel bioreactor with a maximum working volume of 2.0 L. Using the chemically defined medium D, it was possible to produce up to 5.33 g∙L-1 of dry biomass from 40 g∙L-1 glucose. The cells were grown under aerobic conditions with a specific growth rate up to 0.4 h-1 and a yield coefficient for the biomass of 0.13 g cdw·g gluc-1By Nadezda Perepelitsa, Stephan C. Kaiser and Dieter Eibl

  • Cultivation Of Sf-9 Insect Cells And rSEAP Expression In The Wave-Mixed Single-Use Finesse SmartRocker Bioreactor
    Cultivation Of Sf-9 Insect Cells And rSEAP Expression In The Wave-Mixed Single-Use Finesse SmartRocker Bioreactor

    This application note describes the cultivation of Sf-9 suspension cells in the wave-mixed single-use Finesse SmartRocker bioreactor with a maximum working volume of 5 L. Using serum-free, it was possible to produce up to 6.2∙106 cells∙mL-1. The rSEAP expression was induced by the baculovirus expression vector system. Maximum rSEAP activity of up to 58.5 U∙mL-1 was achieved. The results are in the typical range observed in previous cultivations using wave-mixed bioreactor types. By Nadezda Perepelitsa, Stephan C. Kaiser and Dieter Eibl

  • Cultivation Of Sf-9 Insect Cells And SEAP Expression In The Finesse «SmartGlass» Bioreactor
    Cultivation Of Sf-9 Insect Cells And SEAP Expression In The Finesse «SmartGlass» Bioreactor

    This application note describes the cultivation of Sf-9 suspension cells in the Finesse «SmartGlass» vessel bioreactor having a maximum working volume of 2.0 L. Using serum-free medium without components of animal origin viable cell densities of up to 4.964∙106 cells∙mL-1 were achieved. The SEAP expression was induced by the baculovirus expression vector system, which provided maximum SEAP activities of 56.4 U∙mL-1. By Stephan C. Kaiser, Ina Dittler, Nina Steiger and Dieter Eibl

  • Cultivation Of CHO Suspension Cells And SEAP Expression In The Wave-Mixed Single-Use Finesse SmartRocker Bioreactor
    Cultivation Of CHO Suspension Cells And SEAP Expression In The Wave-Mixed Single-Use Finesse SmartRocker Bioreactor

    This application note describes the cultivation of CHO suspension cells in the wave-mixed single-use Finesse SmartRocker bioreactor with a maximum working volume of 5 L. Using a chemically defined minimal medium, it was possible to produce up to 16.4∙106 cells∙mL-1. SEAP expression was induced by medium exchange and a temperature shift. Maximum SEAP activity of up 33.1 U∙mL-1 was achieved. The results are comparable to cultivations in other wave-mixed bioreactor types. By Nadezda Perepelitsa, Stephan C. Kaiser and Dieter Eibl

  • Cultivation Of CHO Suspension Cells And SEAP Expression In The Finesse Glass Bioreactor
    Cultivation Of CHO Suspension Cells And SEAP Expression In The Finesse Glass Bioreactor

    This application note describes the cultivation of CHO suspension cells in the Finesse glass vessel bioreactor having a maximum working volume of 2.0 L. Using chemically defined minimal media cell densities of up to 7.44∙106 cells∙mL-1 were achieved. The SEAP expression was induced by medium exchange and temperature shift. Maximum SEAP activities of up 63 U∙mL-1 were reached. By Stephan C. Kaiser, Katharina Blaschczok and Dieter Eibl

  • Mass Propagation Of Nicotiana Tabacum Cv. BY‐2 Suspension Cells In The Finesse Smartrocker Bioreactor
    Mass Propagation Of Nicotiana Tabacum Cv. BY‐2 Suspension Cells In The Finesse Smartrocker Bioreactor

    This application note describes the mass propagation of Nicotiana tabacum cv. BY-2 (cultivar tobacco Bright Yellow-2) suspension cells in the Finesse SmartRocker bioreactor at laboratory scale. Maximum fresh cell weights of about 351±9 g•L-1, corresponding to packed cell volumes of 74±2 %, were achieved, which shows the applicability of the Finesse SmartRocker bioreactor to cultivate fast growing plant suspension cells. By Nicole Imseng, Stephan C. Kaiser, Nadezda Perepelitsa, and Dieter Eibl

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BIOPROCESS CONTRIBUTING EDITORS

  • FDA, EMA Approval Stats: Are We Measuring Pharma Success The Wrong Way?
    FDA, EMA Approval Stats: Are We Measuring Pharma Success The Wrong Way?

    While approval stats spark declarations of excitement from each regulatory agency and make news headlines, the differences in approval times in particular aren’t necessarily a cause for celebration; rather, they illuminate something much more concerning about the state of global drug development.

  • Opdivo And Praluent Expected To Lead The Class Of 2015
    Opdivo And Praluent Expected To Lead The Class Of 2015

    Which pharma offerings should you keep an eye on in 2015? Thomson Reuters has released its 2015 Drugs To Watch report, with insights into those medications expected to enter the market this year and make a big splash for their developers.

  • How Will AbbVie, J&J, And Amgen Handle The Biosimilar Age?
    How Will AbbVie, J&J, And Amgen Handle The Biosimilar Age?

    Following the approval of the first biosimilar last week, there were a number of questions circulating throughout the industry. My blog from last week addressed two questions about where the biosimilars market is headed, but I also wanted to address a third question I’ve seen cropping up: What are companies with blockbusters going to do to keep revenues intact now that they’re facing biosimilar competition?

  • Who To Watch In The Alzheimer’s Treatment And Research Space
    Who To Watch In The Alzheimer’s Treatment And Research Space

    In an interview with the Triangle Business Journal, Eli Lilly CEO John Lechleiter said 2/3 of drugs fail to show efficacy in Phase 2 trials because there isn’t enough understanding of the targeted disease. He tells the Journal, “While drug hunting remains a vital activity… I think we need to advance, like our ancestors did, from hunting to farming, cultivating the knowledge of disease.”

  • FDA News Roundup: Bristol-Myers Squibb, Bayer, Astellas, And More
    FDA News Roundup: Bristol-Myers Squibb, Bayer, Astellas, And More

    What FDA decisions have you missed in the last week?

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    Sartorius Stedim Biotech

    For the biopharmaceuticals industry, Sartorius offers a comprehensive, globally unique program of products and services, ranging from the discovery of active pharmaceutical ingredients to process engineering, from scale-up and production to compliance with regulatory steps.

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