Downstream Processing White Papers and Case Studies

51. Optimized Purity And Recovery Of A Monoclonal Antibody Using Mixed-Mode Chromatography Media 10/3/2016

    Monoclonal antibodies (mAbs) remain a predominant class of therapeutic protein products on the market because of their wide range of applications in disease treatment and diagnosis. Over the years, upstream technology advancements have helped improve the titer of target antibodies, from merely 1 g/L two decades ago to 10–13 g/L in fed-batch processes and up to 25 g/L in perfusion cultures today (Gronemeyer et al. 2014).

52. Compound Profiling And Toxicity

    Utilizing a systems approach to drug discovery has generated a multitude of high affinity compounds for various classes of molecular targets with different degrees of disease state validation.

53. Biomanufacturing Supply Chains 12/22/2011

    This white paper examines the major issues with biopharmaceutical supply chains and how to balance inventory and risk optimally in the network.

54. Microbial Fermentation In Single-Use Xcellerex™ XDR-50 MO Fermentor System 10/24/2013

    This application note describes the performance of a single-use Xcellerex XDR-50 bioreactor system when used in cultivations of E. coli and of modified Pseudomonas fluorecsens (P. fluorescens) producing a monoclonal antibody (MAb). Both the achieved microbe densities and product yield were shown to be consistent with the performance of conventional stainless steel systems.

55. Biological Contamination Events In Isolators: What Lessons Can Be Learned? 8/17/2012

    Microbiological deviation and biological contamination events have been observed in pharmaceutical isolators including those used in production, sterility test and pharmacy aseptic services. By James Drinkwater, Bioquell UK Process & Compliance Director

56. Micro-Volume Determination Of Labeling Efficiency In A Standard Microplate Reader 2/12/2013

    A variety of methods and reagents have been developed to efficiently label biomolecules. By Peter J. Brescia, Applications Scientist,  BioTek Instruments, Inc.

57. Top 10 Considerations When Selecting An Isolator Supplier

    While price is certainly an important reason for buying any piece of capital equipment, it is not always the top reason. There are important considerations to examine when selecting an isolator supplier.

58. USP <787> Small Volume Testing With Liquid Particle Counters

    By their very nature, biological therapeutics are not only expensive to manufacture but are often produced in small volumes.

59. Comparability Of The Cell-Freeze® (Charter Medical) Freezing Bag To The Cryocyte™ (Baxter) Bag For Cryogenic Storage Of Human Hematopoietic Progenitor Cells 7/11/2011
    Successful cryopreservation of hematopoietic progenitor cells (HPC) is dependent upon a number of factors, including the biopreservation media, freezing rates, and storage using sterile, cryogenically durable storage bags. The Cell-Freeze® cryogenic storage containers are 510(k) cleared for storage, preservation and transfer of hematopoietic progenitor stem cells (HPC’s). By Charter Medical, Ltd.
60. Continuous Biomanufacturing: 10 Reasons Sponsors Hesitate

    The industry is abuzz with talk about continuous biomanufacturing (CB), and its virtues have been well described. Here we will look at some of the barriers or concerns perceived to limit its value to the industry. Justified or not, quite a few concerns have been expressed regarding the implementation of this new, rather disruptive technology.