Downstream Processing Featured Articles

51. Revision Of The EU GMP Guide: EU Commission Publishes Proposals For Chapters 3, 5, 6 And 8 1/24/2013

    On 17 January 2013, the EU Commission published the drafts of 4 revised chapters of the EU GMP Guide. The publication had been expected for a long time now.

52. Avid Bioservices Announces Completion Of Facility Upgrades In Response To Increased Demand For Its Contract Manufacturing Services 12/13/2012

    Avid Bioservices, Inc, a contract manufacturing organization (CMO) focused on the process development and manufacturing of monoclonal antibodies, proteins and enzymes, today announced that its demand for services has reached an all-time high, while projected revenue for its current fiscal year ending April 2013 is expected to surpass $18 million, a 20% increase from the previous fiscal year.

53. FDA Approval Pushes Novartis Into 21st Century Vaccine Development 6/18/2014

    In 2009, the world experienced a global threat in the form of H1N1. Despite a prompt response to the need for a vaccine in the United States, it was still not available until six months later and not enough doses were even produced to cover all Americans. During the year-long battle with the deadly virus, the CDC estimates between 8,870 and 18,300 people died due to H1N1-related complications. In the world of influenza vaccine production using chicken eggs, the response experienced during the H1N1 outbreak is not uncommon. Is this the best our industry can do? Novartis says NO.

54. FDA Approves New Combination Vaccine That Protects Children Against Two Bacterial Diseases 6/14/2012

    The U.S. Food and Drug Administration recently approved Menhibrix, a combination vaccine for infants and children ages 6 weeks through 18 months, for prevention of invasive disease caused by Neisseria meningitidis serogroups C and Yand Haemophilus influenzae type b.

55. Researchers' Sequencing Of Human and Monkey Malaria Genomes Reveals Challenges, Opportunities In Battle Against Parasite 8/5/2012

    Genetic variability revealed in malaria genomes newly sequenced by two multi-national research teams points to new challenges in efforts to eradicate the parasite, but also offers a clearer and more detailed picture of its genetic composition, providing an initial roadmap in the development of pharmaceuticals and vaccines to combat malaria.

56. MorphoSys And Heptares Sign Alliance To Develop Antibody Therapeutics Targeting GPCRs 2/13/2013

    MorphoSys AG (Prime Standard Segment, TecDAX) and UK-based Heptares Therapeutics, the leading GPCR drug discovery and development company, have signed an agreement to discover novel antibody therapeutics targeting G protein-coupled receptors (GPCRs), which are membrane proteins involved in a broad range of biological processes and diseases.

57. New Monoclonal Antibody Developed That Can Target Proteins Inside Cancer Cells 3/13/2013

    Researchers have discovered a unique monoclonal antibody that can effectively reach inside a cancer cell, a key goal for these important anticancer agents, since most proteins that cause cancer or are associated with cancer are buried inside cancer cells.

58. CDER-ETP: A Resource For Innovative Biopharma Firms 1/15/2020

    The FDA’s Center for Drug Evaluation and Research’s Emerging Technology Program (CDER-ETP), is yet another step toward removing slow-moving bureaucracy and red tape that stands in the way of innovative new technologies that drive drug development. 

59. FDA Approves New Seasonal Influenza Vaccine Made Using Novel Technology 1/16/2013

    The U.S. Food and Drug Administration recently announced that it has approved Flublok, the first trivalent influenza vaccine made using an insect virus (baculovirus) expression system and recombinant DNA technology. Flublok is approved for the prevention of seasonal influenza in people 18 through 49 years of age.

60. Cloak And Swagger: Engineers Use Plasmonics To Create An Invisible Photodetector 5/20/2012

    It may not be intuitive, but a coating of reflective metal can actually make something less visible, engineers at Stanford and UPenn have shown. They have created an invisible, light-detecting device that can “see without being seen.” By Andrew Myers