Culture Development White Papers and Case Studies

51. Benefits And Risks Of (UV) Ultraviolet Radiation

    Soon after the discovery of microorganisms, biologists began to observe that many varieties of these creatures were able to be incapacitated by exposure to sunlight. Following the discovery of the ultraviolet bandwidth in 1801, scientists attributed the sun’s lethal effect to this invisible energy. Facilitated by the findings of a large body of experimental evidence collected in the decades following these initial hypotheses, contemporary scientists have determined that nearly all bacterial activity can be eradicated or at least attenuated by some wavelength of ultraviolet energy.

52. 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. 

53. Efficient, High-Titer Monoclonal Antibody Production In A Fed-Batch Process

    This application note shows the feasibility of monoclonal antibody (MAb) production in fed-batch processes using the single-use Xcellerex™ XDR-200 stirred-tank and ReadyToProcess WAVE™ 25 rocking bioreactor systems.

54. Filtration Processes Applied In Therapeutic Monoclonal Antibody Production

    Monoclonal antibodies were among the first biotechnology produced drugs approved by the FDA and are used to treat specific diseases, as ligands in purification schemes and for use as diagnostic reagents. The primary method of monoclonal antibody production involves using murine systems to produce antibodies to specific (human) antigens. The antigens can be nucleic acid or protein molecules associated with a disease state and the antibodies directed against these antigens are exquisitely specific and identical in structure and function. By 3M Purification Inc

55. Filtration Processes Applied In Viral Vector Based Gene Therapy Production

    Gene therapy involves the transfer of genetic material into a patient’s cells in order to correct a disease state. The objective is to provide the necessary genetic material to correct a genetic deficiency and allow a particular therapeutic protein to be temporarily or permanently expressed. Candidates for gene therapy are often missing a particular gene or have deficiencies in their genome preventing them from producing fully functional, therapeutic proteins. By 3M Purification Inc

56. Container And Closure System Integrity Testing In Lieu Of Sterility Testing As A Component Of The Stability Protocol For Sterile Products

    The purpose of stability testing is to provide evidence on how the quality of a substance or product varies with time under the influence of a variety of environmental factors such as temperature, humidity, and light, which enables you to establish or modify recommended storage conditions, retest periods, and shelf life or dating period, as the case may be.