| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
You are here > Biopharmaceutical Glossary Homepage/Search > Drug discovery & development > Biologics Biologics:
antibodies, protein therapeutics & vaccines
glossary & taxonomy
Applications Map Informatics map Technologies map Biology map Finding guide to terms in these glossaries Site Map Related glossaries include Bioprocessing Drug Discovery & development Drug & disease Targets adjuvants - novel vaccines: See under delivery systems: vaccines antibody
constructs:
Antibody Drug Products January 13-14,
2011 Coronado, CA Program
| Register
| Download Brochure antibody
therapeutics: Though therapeutic antibodies have
achieved phenomenal success, many challenges stand waiting to be addressed.
This meeting will explore some of the successes while reviewing the inherent
obstacles that can block progression into the clinic with an eye for ferreting
out the optimal protocols and highlighting the best technologies that support
development. The focus for the meeting is the momentous task of designing a
soluble and glycosylated therapeutic antibody that can be delivered
efficaciously and penetrate into the tissue or tumor. See also monoclonal antibodies, protein therapeutics antibodies: Therapeutic
and diagnostic antibodies continue to make in inroads in biomedicine, but the
successful application of these products requires smart discovery and
development. This conference will explore the latest methods to overcome
challenges and open new opportunities for making these valuable proteins viable.
biological product: IUPAC biologic(s): Any virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic products, or analogous product applicable to the prevention, treatment, or cure of diseases or injuries in man. An overview of drug development, Barnett/Parexel, 2000 http://www.barnettinternational.com/EducationalServices_Publication.aspx?p=6464&id=97141 Include
blood, vaccines, tissue, allergenics and biological therapeutics.
CBER, FDA, US website http://www.fda.gov/cber/about.htm Compare drug.
In the US biologics and drugs have been regulated by different
Centers at the FDA (CBER, CDER) , but this is changing. Biologics,
in contrast to drugs that are chemically synthesized, are derived from living
sources (such as humans, animals, and microorganisms). Most biologics are
complex mixtures that are not easily identified or characterized, and many
biologics are manufactured using biotechnology. Biological products often
represent the cutting- edge of biomedical research and, in time, may offer the
most effective means to treat a variety of medical illnesses and conditions that
presently have no other treatments available. http://www.fda.gov/cber/about.htm Veterinary biologics
(vaccines, bacterins, diagnostics, etc, which are used to prevent, treat, or
diagnose animal diseases) are regulated by the U.S. Department of Agriculture.
http://www.aphis.usda.gov/vs/cvb/ biopharmaceutical:
Any therapeutic biological compound, including recombinant
proteins, monoclonal and polyclonal antibodies, antisense
oligonucleotides, therapeutic genes, and recombinant and DNA vaccines.
Tufts Center for the Study of Drug Development, Glossary, 2007 http://csdd.tufts.edu/InfoServices/Glossary.asp biopharmaceuticals: Biopharmaceuticals are
generally complex macromolecules derived from recombinant DNA technology, cell
fusion, or processes involving genetic manipulation. They include recombinant
proteins, genetically engineered vaccines; therapeutic monoclonal antibodies;
and nucleic acid based therapeutics, including gene therapy vectors.
Industry Canada, Biopharma Companies and Products in the Pipeline, 2004 http://strategis.ic.gc.ca/epic/internet/inbio-pha.nsf/en/Home biosimilars: Regulatory Affairs bispecific
antibodies: Empowered
Bispecific Antibodies and Antibody-Drug Conjugates October
6-7, 2010 Hannover Germany Program | Register | Download Brochure biotechnology: Genetic manipulation &
disruption glossary biotechnology
drugs: Defined as products based
on recombinant DNA, monoclonal antibodies, continuous cell lines, gene therapy,
and cellular therapy. Product Definition, The Biopharmaceutical Sector, Industry
Canada, 2003
http://strategis.ic.gc.ca/epic/internet/inbio-pha.nsf/en/df00020e.html#2.1 bi-specific
antibodies: interest in bispecific and
multivalent antibodies has been renewed because of advances that now allow them
to be manufactured in a stable and reliable manner. This has opened up the
field to a multitude of approaches for creating bispecific antibodies against a
variety of targets. The decision-making process about when a bispecific or
multiclonal approach should be used, and what mechanism is likely to be the most
effective against a given indication. PEGs
Protein Engineering Summit May 2010,Boston MA
bioanalytical
challenges:
biogenerics: Regulatory Affairs biological product: IUPAC biologics: Regulatory Affairs biopharmaceuticals: Regulatory Affairs biosimilars: Regulatory Affairs biotech drugs: Regulatory Affairs biotherapeutic
targets: cell therapeutics: Cell technologies & therapies See also Stem cells high content assays formulation-
biologics:
Part of
gene therapy: Targeting
Genes, Engineering Vectors, Designing Constructs & Optimizing
clones January 10-11, 2011
Coronado, CA Program | Register
| Download Brochure
PEGs Protein Engineering
May 2010 includes immunogenicity: Drug safety immunotherapeutics:
ligand
binding assays: One of the key reasons
Protein Therapeutics have achieved significant success stems from their ability
to bind to specific targets, such as receptors or cell surface proteins, with
high affinity. As Protein and other Macromolecule Therapeutics become more
complex, bioanalytical challenges have increased, especially for multi-domain
and multi-valent biopharmaceuticals. Ligand Binding Assays (LBAs), which
indirectly measure reactions with the binding reagents, continue to be the
preferred method of analyzing macromolecule therapeutics. However, to date
no clear guidance or consensus exists that outlines how to consistently monitor
and validate specificity and selectivity for ligand binding assays, and what
methods are necessary to differentiate between free and total
therapeutic. Additionally, there is a need to establish criteria for
reagent quality, lot-to-lot consistency, and maintaining a sustainable reagent
supply. Bioanalytical challenges for
optimizing protein therapeutics
PEGs
Protein Engineering Summit May 2010,Boston MA ligand: Pharmaceutical biology: monoclonal
antibodies: Monoclonal antibodies represent about
half of all biologics in development, with more than 150 compounds currently in
clinical trials. However, the attrition rate of monoclonal antibodies has
been higher than for other biologics. While early studies in pre-clinical
settings have been encouraging, the predictability and confirmation of these
same findings in humans has been difficult. The reasons for this may include: 1)
target antigen properties; 2) antibody design; 3) PK and PD properties; 4)
limited species cross reactivity (limited availability of suitable animal
models); 5) appropriate translation of pre-clinical data to pick FIH dose; and
6) accurate identification of patients who could benefit from target therapy.
In the more than 30 years since the first process for creating monoclonal antibodies, or mAbs, was introduced, they have remained a centerpiece of the growing biotechnology industry. Twenty-four therapeutic mAbs have been approved, several of which have attained blockbuster status, with sales reaching the coveted billion-dollar mark and well beyond. Two drugs, Remicade and Rituxan, generated sales of about $4 billion each in 2006, and global sales for this entire portfolio approached $20 billion in that year. Insight Pharma Reports Monoclonal Antibodies: Pipeline Analysis and Competitive Assessment, 2007 A single species of immunoglobulin molecules produced by culturing a single clone of a hybridoma cell. MAbs recognize only one chemical structure, i.e., they are directed against a single epitope of the antigenic substance used to raise the antibody. [IUPAC Biotech] Antibodies produced by clones of cells such as those isolated after hybridization of activated B lymphocytes with neoplastic cells. These hybrids are often referred to as hybridomas. MeSH, 1982 Broader term: antibody; Related terms: clinical antibodies, cloning, hybridoma, fully humanized antibodies, polyclonal antibodies, recombinant antibodies, therapeutic antibodies, polyclonal antibodies molecular therapeutics: Current Opinion in Molecular Therapeutics is published bimonthly and covers the broad field of molecular medicine, including viral and non-viral gene therapy, oligonucleotides, peptide therapeutics, antibody approaches, molecular vaccines, and the technologies underlying genomics and proteomics. Scope note: Current Opinion in Molecular Therapeutics, BioMedCentral http://www.biomedcentral.com/curropinmolther/ NME New Molecular Entity:
Regulatory Affairs pharming: Genetic manipulation & disruption protein aggregation; Drug delivery
protein therapeutics: Once a rarely used subset of medical treatments, protein therapeutics have increased dramatically in number and frequency of use since the introduction of the first recombinant protein therapeutic human insulin 25 years ago. Protein therapeutics already have a significant role in almost every field of medicine, but this role is still only in its infancy. Protein therapeutics: a summary and pharmacological classification, Benjamin Leader, Quentin J. Baca & David E. Golan Nature Reviews Drug Discovery 7, 21-39 (January 2008) | doi:10.1038/nrd2399 See also antibody therapeutics, protein aggregation recombinant
antibodies: Drug & disease targets
Bibliography
IUPAC definitions are reprinted with the permission of the International Union of Pure and Applied Chemistry. |
Contact
| Privacy Statement |
Alphabetical
Glossary List | Tips & glossary
FAQs | Site Map
Part of 
