Drug Discovery 301

Emily BurkeBiologics, Biomanufacturing, Cocktail Fodder

DRUG DISCOVERY 301 Biotech Primer Weekly wrapped up last year by exploring the first two stages of drug discovery. We looked at how pharmaceutical companies identify drug targets, or the molecules (usually proteins) involved in an illness that an ‘as yet undeveloped drug’ will hopefully act on. Next, we examined how researchers develop those pharmaceutical candidates. Now we turn to … Read More

Vaccines: Powerful Simplicity

Emily BurkeBiologics, Biomanufacturing, Cocktail Fodder, The WEEKLY, Vaccine

Vaccines: Elegant, Powerful Simplicity Anyone who’s suffered the aches and fever of influenza has good reason to value the simple flu shot. In fact, millions roll up their sleeves and literally take their medicine. The US Centers for Disease Control (CDC) (Atlanta, GA) estimates that about 146 million doses of influenza vaccine went to doctors’ offices, health departments, and the … Read More

Post-translational Modifications In Biotech

Emily BurkeBiologics, Biomanufacturing, Biotech Basics, Cancer, Deoxyribonucleic Acid (DNA), Drug Development, Drug Targets, Mechanism of Action, Monoclonal Antibodies

Basic Science Meets Application “Post-translational modification” may not be a term you hear every day, but it is critically important to the biotech industry—from understanding how cancer develops to producing biologics. Breaking the term down, we know that: “post” means “after.” “translation” is “the cellular process of making proteins.” “modification” means “change.” So, a post-translational modification (PTM) simply means that … Read More

Interchangability Denied To First US Approved Biosimilar

Emily BurkeBiologics, Biomanufacturing, Biosimilars, Business of Biotech, Drug Approvals, FDA, Mechanism of Action, Term of the Week, The WEEKLY

G-CSF: The original Innovator Sandoz’s (Princeton, NJ) Zarzio rode the first wave into the U.S. biosimilars market after it received FDA approval last week. Zarzio is similar to Amgen’s (Thousand Oaks, CA) Neupogen and both of these medications are recombinant versions of the “go to” stimulator for white blood cell production—known as granulocyte-colony stimulating factor (G-CSF). White blood cells (WBC) … Read More

Biosimilars: Ready or Not, Here They Come

Emily BurkeBiologics, Biomanufacturing, Biosimilars, Biotech Basics, Drug Development, Easily Confused, FDA, Small Molecule Drugs, The WEEKLY

Last week, the FDA’s Oncologic Drugs Advisory Committee unanimously recommended Novartis’  biosimilar version of Amgen’s megahit Neupogen (filgrastim), effectively paving the way for the first US biosimilar approval in the near future. Filgrastim is a recombinant version of a naturally-occurring protein which stimulates the bone marrow to increase production of white blood cells. Patients undergoing chemotherapy, as well as those receiving bone marrow … Read More

Cultivating Biologics From Plants?

Emily BurkeBiologics, Biomanufacturing, Biotech Basics, The WEEKLY

A FRESH LOOK AT TOBACCO AND BIOLOGICS Tobacco plants pioneering the production of monoclonal antibodies for an experimental Ebola treatment turned out to be quite the head scratcher for last Thursday’s WEEKLY readers. With tobacco’s reputation polluting our recent memories, let’s take a fresh look at tobacco and biologics. To date, no approved therapeutic protein has been produced in whole plants—ever! … Read More