Adenoviruses – A group of viruses that cause a variety of subclinical, self-limiting diseases, including the common cold, pneumonia, and gastroenteritis.
AdVac® technology – Crucell’s proprietary adenovirus vectors used for the development of new and more efficient vaccines.
AIDS – Acquired immunodeficiency syndrome, the disease caused by the HIV virus.
Antibody – Protein made naturally by the body’s immune system as part of the principle defense mechanism against pathogens. Antibodies recognize and bind to a pathogen, triggering the elimination process of the pathogen and protecting the subject against disease.
Attenuated virus vaccines – Vaccines containing an active virus that has been weakened so it is no longer dangerous upon administration.
Biologics – Biological products, such as vaccines or proteins, made for use as medicines. The first biological made by recombinant DNA technology was insulin, approved for human use in 1982.
BMF – Biologics Master File. A document at the US Food and Drug Administration (FDA) that contains all know-how, history and results of safety testing regarding Crucell’s cell line, PER.C6®. The BMF is annually updated with new information by Crucell and some of its licensees and can be used by all PER.C6® licensees for reference when taking products based on PER.C6® technology towards the clinic in the USA.
Cell line – Specific cells that can grow indefinitely given the appropriate medium and conditions.
Cholera – Cholera is an acute intestinal infection often caused by eating food or drinking water contaminated with the Vibrio cholerae bacteria. In its most severe form, the disease can cause a sudden onset of acute watery diarrhea that can lead to severe dehydration, kidney failure and ultimately death if treatment is not promptly given.
Clinical Trials – Obligatory tests in human individuals, governed by strict regulations aimed at proving safety and efficacy of a product.
Deoxyribonucleic acid (DNA) – The genetic material of all living things (except for RNA-carrying viruses, such as HIV). DNA is a double–stranded, helical molecular chain found within each cell. It contains the information needed for cells to produce proteins, molecules that enable cells to reproduce and carry out their functions.
Drug Target – Naturally occurring molecules associated with the onset or progression of a disease towards which drugs are directed to counteract or prevent disease processes.
Ebola – A virus that inflicts 50-80% mortality by causing high fever and massive internal bleeding, followed by organ failure. Epidemics of the virus occur commonly in Africa. No natural reservoir for the Ebola virus has yet been found.
Efficacy – In vaccine research, the ability of a vaccine to protect people against disease, which in the field of infectious diseases can be caused by parasites, viruses or bacteria. Vaccine efficacy is ultimately established in large scale human clinical trials.
Encephalitis – An inflammation of the brain that can be the result of bacterial or viral infection.
Enzyme – A protein that accelerates a specific chemical reaction without altering itself.
FDA – The US Food and Drug Administration. Promotes and protects the public health by helping safe and effective products, including medicines, reach the market in a timely way, and monitoring products for continued safety after they are in use.
Gene Therapy – Treatment of inherited or acquired genetic diseases through the transfer of genetic material into the appropriate cells of a human individual to replace absent or defective genes or to counteract incorrect biological processes caused by defective genetic material.
Genome – A set of chromosomes and genes that an individual inherits from his or her parents.
Glycosylation – The addition of polysaccharides to proteins during their assembly in the cell.
Hemorrhagic – Causing bleeding.
HIV – Human immunodeficiency virus, the virus that causes AIDS.
Immune System – The body’s defense system against invading pathogens, such as viruses, parasites and bacteria, as well as against other abnormal manifestations of the body’s integrity, such as tumors and transplants.
Inactivated virus vaccines – Vaccines based on whole virus particles that have been treated to prevent them from exerting their normal pathogenic action. Upon vaccination, the inactive virus particles are presented to the immune system, thus inducing an immune reaction. The Salk polio vaccine is a good example of the inactivated virus vaccine.
Influenza – Commonly called “the flu”’ influenza is a highly infectious disease caused by viruses that infect the respiratory tract. Influenza occurs in yearly epidemics and can lead to serious disease, such as pneumonia, predominantly in the elderly.
Lassa – Lassa fever is an acute viral illness that occurs in West Africa, with the number of cases being as many as 100,000 to 300,000, with approximately 5,000 deaths. Transmitted by a rodent known as the multimammate rat, Lassa fever is highly infectious in many cases deadly.
MAbstract® technology – Crucell’s proprietary technology used for the discovery of antibodies binding to disease-specific proteins, viruses and even whole cells and tissues.
Malaria – A parasitic disease transmitted by the Anopheles mosquito. Symptoms include chills, fever, headache, nausea and vomiting. Life threatening severe anemia or cerebral malaria may occur in some infected individuals.
Manufacturing Platform – A technology suited for manufacturing biological products.
Marburg – A virus that causes hemorrhagic fever affecting both humans and primates. Caused by an animal-borne RNA virus, Marburg is in the filovirus family, which also includes the four species of Ebola virus.
Monoclonal Antibody – Antibodies made from a single clone of cells with specific binding properties.
Pathogen – Disease-causing agents such as viruses, parasites or bacteria.
PER.C6® technology – A human designer cell line for the efficient development and large-scale manufacturing of biopharmaceutical products. The PER.C6® cell line is made from a single healthy, human cell that has been purposefully immortalized so that it can grow indefinitely and can be expanded efficiently without the need for materials that allow cell attachment (i.e. microcarriers) or the need for serum derived from non-human sources.
Phage – Short for bacteriophage, a phage is a virus that infects bacteria and possesses the ability to integrate into the genetic material of its host cell.
Phage Display Library – A technology for rapidly generating antibodies with desired binding properties. Phage display libraries contain billions of genetically engineered phages that express unique antibody fragments on their surface.
Pneumonia – An inflammation of the lungs caused by viruses or bacteria that trigger an immune response resulting in the presence of fluid in the lungs that obstructs.
Protein – Organic macromolecules (e.g. hormones, enzymes, antibodies) fundamental to all living cells. Proteins are composed of one or more chains of amino acids, the ‘building blocks’ generated from the genetic code present in the DNA of all living organisms
Rabies – Viral disease of dogs and other mammals, transmissible to humans through the saliva. Infects the central nervous system causing encephalopathy and ultimately death if not treated before symptoms appear.
Recombinant – Biological material (e.g. proteins, antibodies, vaccine vectors) manufactured by genetic engineering in specialized laboratories.
Recombinant vaccines – Engineered viruses or bacteria into which harmless genetic material and other disease-causing organisms are inserted. Employing delivery agents called vectors, recombinant vaccines aim to create a strong antibody and T-cell immune response leading to protection against the targeted disease. While no recombinant vaccines are currently licensed for general use in the United States, promising results in diverse animal models have been obtained to counter viruses such as HIV, Ebola and the malaria parasite Plasmodium falciparum.
Replication – A complex process whereby the “parent” strands of DNA in the double helix are separated and each one is copied to produce a new “daughter” strand. This process is said to be “semi-conservative” since one of each parent strand is conserved and remains intact after replication has taken place.
Retrovirus – HIV and other viruses that carry their genetic material in the form of RNA rather than DNA. These viruses also contain the enzyme, reverse transcriptase, which transcribes RNA into DNA. That process is the opposite of what normally occurs in animals and plants, where DNA is made into RNA; hence the prefix “retro.”
Ribonucleic acid (RNA) – A single-stranded molecule composed of chemical building blocks similar to those of DNA. RNA is the sole genetic material of retroviruses and an intermediary in making proteins in all living things.
Serum – The liquid portion of blood that remains after the removal of clotting proteins and cells. Most cells grown in a laboratory are dependant on nutrients that are present in serum. These days, the pharmaceutical industry prefers to grow cells in the absence of serum for safety reasons.
STAR® technology – Production technology specifically designed to enhance recombinant human antibodies and proteins on mammalian cell lines such as PER.C6® and the widely used Chinese Hamster Ovary (CHO) cell line. Has the potential to increase production yields, thereby reducing costs.
Target – In the context of Crucell’s business, a molecule (on proteins, viruses or disease-associated cells) against which a therapeutic antibody has been developed.
Transgenic – Used to describe an animal that contains genes from a different species. For example, transgenic mice are given human genes for the production of vaccines.
Tuberculosis (TB) – An infectious bacterial disease characterized by the growth of nodules (tubercles) in the tissues, especially the lungs.
Vaccine – A substance composed of components of a pathogen that stimulate an immune response which allows the vaccinated individual to resist future infections and disease.
Vector – A vehicle for transferring genetic material into appropriate cells or tissues inside the body.
Virology – The study of viruses.
Virosome – A virosome is a unilamellar phospholipid bilayer vesicle presenting virus antigens for use in vaccination.
West Nile virus – A virus transmitted by mosquitoes that causes West Nile fever, which can lead to paralysis, coma, and death. First identified in Africa, the virus has now surfaced in North America and Europe in recent years.
Wild-type – An unaltered virus as found in nature.