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Biologics Biologics:
antibodies, protein therapeutics & vaccines
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Drug delivery Drug
Discovery & development Drug &
disease Targets Protein Informatics
Protein Technologies Proteomics
adjuvants
Drug delivery vaccines
antibody:
A protein (immunoglobulin) produced by the immune system
of an organism in response to exposure to a foreign molecule (antigen)
and characterized by its specific binding to a site of that molecule (antigenic
determinant or epitope). [IUPAC Compendium]
A protein, belonging to the class of immunoglobulins, designed to bind
a specific antigen in order to remove it from the body. They are synthesised
exclusively by B-lymphocytes, in millions of forms, each with a different
amino acid sequence and a specific for a specific antigen
(antigenic determinant or epitope). [IUPAC Bioinorganic]
Immunoglobulin molecules having a specific amino acid sequence by virtue of which they interact only with the antigen that induced their synthesis in cells of the lymphoid series (especially PLASMA CELLS), or with an antigen closely related to it.
MeSH Narrower terms:
domain antibodies, fully human antibodies, hybridoma, monoclonal antibodies, polyclonal antibodies,
recombinant antibodies, therapeutic antibodies,. Need
definitions for primary antibodies, secondary antibodies Related terms: epitope,
immunogen, immunoglobulin; Assays &
screening competitive immunoassay, immunoassay; Microarrays
antibody microarray antibody affinity:
A measure of the binding strength between antibody and a simple hapten or antigen determinant. It depends on the closeness of stereochemical fit between antibody combining sites and antigen determinants, on the size of the area of contact between them, and on the distribution of charged and hydrophobic groups. It includes the concept of "avidity," which refers to the strength of the
antigen- antibody bond after formation of reversible complexes. MeSH, 1979
antibody
constructs:
Novel
Antibody Constructs & Alternative Scaffolds October 11-12, 2011
• Hannover Germany Program
| Register
| Download Brochure
antibody drug conjugates:
Antibody Drug Conjugates: Opening Up New Opportunities for
Pre-Clinical Development of Biologics May 3-4, 2012 • Boston, MA Program | Register | Download
Brochure The exquisite specificity of
monoclonal antibodies (mAbs) is being exploited by using them as a targeting
device for therapy. This approach promises to minimize side effects while
maximizing the therapeutic potential of the drug. mAbs can be combined with
radiation, drugs, immunotherapy or toxins with limitless possibilities for
enhancing their therapeutic potential. The encouraging data being collected from
antibody-drug conjugates currently in clinical trials shows that very impressive
response rates are attainable. Plan to attend to see where this newest phase of
antibody engineering is leading.
antibody
drug products: Therapeutic
Developments with Novel Antibody Products October 12-13, 2011 •
Hannover Germany Antibody-based products currently revolutionizing
therapeutics will be addressed, including antibody-drug conjugates, bispecific
antibodies, and other novel constructs. These new antibody designs are
overcoming nagging challenges, such as size and penetration, and enhancing
half-life, PK, and specificity. Antibody Drug Products January 13-14,
2011 • Coronado, CA Program
| Register
| Download Brochure Order CD antibody
engineering:
Engineering Antibodies May 2-3, 2012 • Boston, MA Program | Register | Download
Brochure NFCR Center for
Therapeutic Antibody Engineering Glossary
,
National Foundation for Cancer Research, Dana Farber Cancer Institute http://research.dfci.harvard.edu/nfcr-ctae/research/tech_glossary.php
antibody
libraries:
Phage
and yeast display are used to develop high quality antibody libraries with vast
diversity. The speed of this approach offers advantages in that the libraries
can be screened for binding to multiple antigens, and the antibodies selected
can be further enhanced for improved affinity or potency. Techniques for
improving protein and antibody pharmacokinetics and bioprocess characteristics
will be discussed, as well as refinements for antibody engineering. New topics
this year will include antibodies and proteins against novel targets, display of
membrane proteins, and next-generation sequencing for creating diverse antibody
libraries and selections. Phage
& yeast display of antibodies and proteins PEGS:
the essential protein engineering summit May 9-13, 2011 •
Boston, MA Program | Register
| Download Brochure
The second stage of antibody or drug diagnostic
development - the optimization - can sometimes be the most difficult. This
conference will present methods researchers can apply to make their antibody the
best, most functional and least immunogenic it can be. antibody
therapeutics: Antibody-based therapeutics have progressed into expanded
applications through engineering breakthroughs and computational initiatives. Novel designs are
creating therapeutic antibodies that minimize unwanted properties while
improving specificity and half life. Antibodies for the 21st Century
January 12-13, 2011 • Coronado, CA
Program | Register
| Download Brochure Development of Antibody-Based Therapeutics DVD
May 16, 2010
antigen: A compound (protein, polysaccharide, microorganism,
virus) foreign to the body that induces the production of specific antibodies.
[IUPAC Bioinorganic] Related terms antibody, epitope
antisense therapy:
http://en.wikipedia.org/wiki/Antisense_therapy
See also Pharmaceutical biology
antisense
biogenerics:
Regulatory Affairs See also
biosimilars biological
product:
Virus, therapeutic serum, toxin, antitoxin, or
analogous product applicable to the prevention, treatment, or cure of diseases
or injuries in humans and/or animals. Note:
The term “analogous product” may include essentially all biotechnology-derived
products and procedures including gene therapy,
transgenics, and somatic cell therapy.
IUPAC
Pharmaceutics
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 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. About CBER, FDA, US http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CBER/ucm123340.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/ Include
blood, vaccines, tissue, allergenics and biological therapeutics. Biologics
Partnering Forum: Emerging Antibody and Protein Engineering
April 28-29, 2012 • Boston, MA Program | Register | Download
Brochure
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 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:
Comparability for Change
Implementation and for Biosimilars April 6-7,
2011 • Bethesda, MD The resurgence of bispecific antibodies can be attributed to recombinant
technologies now available to produce a stunning array of constructs that are
making their way to the clinic. The approaches vary from strategies that use T
cell or immune engagement, to dual receptor targeting, or dual ligand binding.
This conference will highlight new, unpublished work in this emerging field, and
will encapsulate the diversity of approaches for creating novel bi- or
tri-specific antibodies. This represents the very forefront of antibody
engineering and promises to be a comprehensive look at the innovation in the
field. Bispecific
Antibody Therapeutics January
12-13, 2012 • Coronado, CA Program | Register | Download
Brochure Hybrid,
artificially produced antibodies in which each of two antigen-binding sites is
specific for separate antigenic determinants. Nature Glossary http://www.nature.com/nrc/journal/v2/n10/glossary/nrc903_glossary.html It is
important to understand the distinction between biotechnology as a new
process technology and as a drug discovery research tool. The first
uses genetic engineering to manufacture large molecular weight drugs that cannot
be directly synthesized or extracted. The second involves understanding the
molecular basis of disease and the search for new therapeutic targets
using techniques such as cloned receptors as screens or transgenic organisms
created through gene knock-out technologies to determine protein function; most
of the focus is on small molecule drugs that interact against those targets. As
the pharmaceutical industry is using biotechnology in drug discovery, it will
likely maintain its dominant position in small molecules, but the development
and manufacture of protein based therapeutics requires a completely different
set of core competencies. Product
Definition, The Biopharmaceutical Sector, Industry Canada, 2003
http://strategis.ic.gc.ca/epic/internet/inbio-pha.nsf/en/df00020e.html#2.1
Related
terms: Business of biotechnology biotechnology
firms, biotechnology industry biotherapeutics:
PepTalk's Pipeline Three explores the pioneering world of protein-based
therapeutics, from novel constructs to enhanced in vivo effects. The
varied designs of Fusion Proteins will be illustrated
including development and clinical data. How Antibody Therapeutics are
engineered to achieve optimized properties will be discussed along with the new
wave of bispecifics and drug conjugates that are realizing clinical success.
The entire week encompasses the state of the art in antibody and recombinant
protein therapeutics, and provides a review of next generation therapeutics. biotransformation:
The chemical conversion of substances by living
organisms or enzyme preparations. [IUPAC Medicinal
Chemistry]
The chemical alteration of an exogenous substance by or in a biological system. The alteration may inactivate the compound or it may result in the production of an active metabolite of an inactive parent compound. The alteration may be either
non- synthetic (OXIDATION- REDUCTION; HYDROLYSIS) or synthetic (glucuronide formation,
sulfate conjugation, ACETYLATION; METHYLATION). This also includes metabolic detoxication and clearance.
MeSH, 1970
cell therapeutics,
cellular therapy: The
FDA defines cell therapy as, “The prevention, treatment, cure or mitigation of
disease or injuries in humans by the administration of autologous, allogeneic or
xenogeneic cells that have been manipulated or altered ex vivo.”1
The goal of cell therapy, overlapping with that of regenerative medicine, is to
repair, replace or restore damaged tissues or organs. Cell therapy may take the
form of a stem cell transplant such as a hematopoietic cell transplant that is
used to restore the blood and immune system of patients with leukemia, lymphoma
or other blood disorders. Pall Corp. FAQs Cell therapy and regenerative medicine
http://www.pall.com/medical_38848.asp
Related terms: gene
therapy, myoblasts, stem cells; Cancer cancer
vaccines See
also high content assays Stem cells
DNA vaccines:
Recombinant DNA vectors encoding antigens administered
for the prevention or treatment of disease. The host cells take up the
DNA, express the antigen, and present it to the immune system in a manner
similar to that which would occur during natural infection. This induces
humoral and cellular immune responses against the encoded antigens. The
vector is called naked DNA because there is no need for complex formulations
or delivery agents; the plasmid is injected in saline or other buffers. MeSH,
1997 Broader term:
vaccines Narrower term: naked DNA vaccines DNA Vaccine.com
http://dnavaccine.com/
effector functions
antibodies:
Mastering the ability to modify antibodies' effector functions
-- whether a critically needed or unwanted component -- offers a promising
approach to improving antibody properties and creating more efficacious
therapeutics. Effector
Functions to Optimize Efficacy of Therapeutic Antibodies DVD
January 11, 2011 epitope:
Any part of a molecule that acts as an
antigenic determinant.
A macromolecule can contain many different epitopes each capable of stimulating
production of a different specific antibody. [IUPAC Compendium] See also
definition in IUPAC
Provisional glossary Biomolecular Screening
Sites on an antigen that interact with specific antibodies.
MeSH, 1996
Sites involved in noncovalent interactions.
NS Greenspan and E Di Cera
"Defining epitope: It’s not as easy as it seems" Nature Biotechnology 17:936-
937
Oct. 1999
Related terms antibody, antigen,
hapten; Narrower terms: conformational epitopes
Wikipedia http://en.wikipedia.org/wiki/Conformational_epitope
linear epitopes
Wikipedia http://en.wikipedia.org/wiki/Linear_epitope
Also known as discontinuous epitopes. Mimotopes
Wikipedia http://en.wikipedia.org/wiki/Mimotope
epitope mapping: Maps, genomic &
genetic first
in humans biologics:
Strategies
for selection of lead biopharmaceuticals with enhanced manufacturability and
development of production cell lines that can be used throughout development
improve process economics. However, the pressure to initiate first-in-human
trials drives companies to implement discovery, cell line development, and
platform manufacturing approaches that enable faster entry into the clinic.
These sub-optimal approaches force companies to introduce new cell lines or
processes later in development and incur risks of comparability failure,
timeline impact, or other delays in the program. The recent FDA Phase I guidance
appears to reduce early development and manufacturing requirements, but the
impact of following a sub-optimal path in early development may have a
significant impact on later development, scalability, comparability, and process
economics, which must be considered when deciding how to initiate a new
development program.
Speed to First-in-Human Trials for Biopharmaceuticals DVD June 23, 2010 Global Web
Symposium
formulation
biologics: Drug delivery
gene-based therapy:
Therapies using or targeting genes, antisense or naked
DNA. Related terms: cellular
therapy, gene therapy, transfection. Google = about 663 May 8, 2003.
about 789 Apr. 27, 2005; about 24,800 Nov 10, 2006
gene therapy: Targeting
Genes, Engineering Vectors, Designing Constructs & Optimizing
clones January 10-11, 2011 •
Coronado, CA Program | Register
| Download Brochure The introduction of new genes into cells for the purpose of treating disease
by restoring or adding gene expression. Techniques include insertion of
retroviral vectors, transfection, homologous recombination, and injection of new
genes into the nuclei of single cell embryos. The entire gene therapy process
may consist of multiple steps. The new genes may be introduced into
proliferating cells in vivo (e.g., bone marrow) or in vitro (e.g.,
fibroblast cultures) and the modified cells transferred to the site where the
gene expression is required. Gene therapy may be particularly useful for
treating enzyme deficiency diseases, hemoglobinopathies, and leukemias and may
also prove useful in restoring drug sensitivity, particularly for leukemia.
MeSH, 1989
Gene therapy is
in its infancy, and current gene therapy is primarily experimental, with
most human clinical trials only in the research stages. ... Gene therapy can be targeted to somatic (body) or germ (egg and sperm)
cells. In somatic gene therapy the recipient's genome is changed, but the change is not passed
along to the next generation. In germline gene therapy, the parents egg
and sperm cells are changed with the goal of passing on the changes to
their offspring. Germline gene therapy is not being actively investigated,
at least in larger animals and humans, although a lot of discussion is
being conducted about its value and desirability. Many people falsely assume that germline gene therapy already is being
done with regularity. News reports of parents selecting a genetically
tested egg for implantation or choosing the sex of their unborn child
may lead the public to think that gene therapy is occurring. Actually,
in these cases, genetic information is being used for selection. No cells
are altered or changed. [Oak Ridge National Lab, US "Gene Therapy" Oct.
2000] http://www.ornl.gov/hgmis/medicine/genetherapy.html
The term 'gene therapy' encompasses at least four types of application of genetic engineering for the insertion of genes into humans. The scientific requirements and the ethical issues associated with each type are discussed.
Somatic cell gene therapy is technically the simplest and ethically the least controversial. The first clinical trials will probably be undertaken within the next
year [1986]. Germ line gene therapy will require major advances in our present knowledge and it raises ethical issues that are now being debated. In order to provide guidelines for determining when germ line gene therapy would be ethical, the author presents three criteria which should be satisfied prior to the time that a clinical protocol is attempted in humans.
Enhancement genetic engineering presents significant, and troubling, ethical concerns. Except where this type of therapy can be justified on the grounds of preventive medicine, enhancement engineering should not be performed. The fourth type,
eugenic genetic engineering, is impossible at present and will probably remain so for the foreseeable future, despite the widespread media attention it has received.
W. French Anderson "Human gene therapy: scientific and ethical considerations" J Med Philosophy
10 (3): 275- 291, Aug. 1985 Google = about 501,000 May 8, 2003;
about 1,530,000 June 10, 2004; about 3,790,000 Nov 10, 2006, about 4,170,000 Jan
3, 2008 first in humans
biologics Speed to First-in-Human Trials for Biopharmaceuticals DVD June 23, 2010
immunogen:
A substance that elicits a cellular immune response and/ or antibody production (cf.
antigen). IUPAC Compendium
immunogenicity:
Drug safety
immunogenomics: Research in the
Immunogenomics Laboratory is focused around the study of the organisation,
function and evolution of vertebrate defense genes, particularly those encoded
by the Major Histocompatibility Complex (MHC) and the Leukocyte Receptor Complex
(LRC). Both complexes form integral parts of the immune system. The MHC is the
most important genetic region in relation to infection and common disease such
as autoimmunity. Driven by pathogen variability, immune genes have
become the most polymorphic loci known, with some genes having over 500 alleles.
The main function of these genes is to provide protection against pathogens and
they achieve this through complex pathways for antigen processing and
presentation. However, even subtle changes in these pathways can lead to genetic
miscommunication and result in disease, particularly autoimmune disease. This
genetic balancing act also presents a major challenge to transplant medicine
where the aim is to minimise the rejection of transplants while not having to
compromise the patient's immune system. Stephan Beck, Team 50
Immunogenomics Lab, Wellcome Trust Sanger Institute, UK http://www.sanger.ac.uk/Teams/Team50/
Google = about 211 May 8, 2003;
about 600 Apr. 28, 2004; about 17,300 Nov. 7, 2005, about 33,700 Oct. 25,
2006; about 34,100 Nov 16, 2009 immunome,
immunomics,
immunoproteomics : -Omes & omics glossary
immunotechnology: Technology
based on applications of cells and molecules of the immune system. A major
research interest is the application of human recombinant antibodies and
antibody fragments in medical and industrial applications, as well as studies of
mechanisms underlying somatic mutations in B cells and IgE switch in allergy.
The use of synthetic antibodies in proteome analysis, including protein array
technology is also pursued as well as gene array analysis of the transcriptome.
B cell malignancies is one focus in antibody and gene therapy projects as well
as viral infection in molecular breeding projects. [Dept. of Immunotechnology,
Lund Univ., Sweden, 2002 http://www.immun.lth.se/
Google = about 5,620
June 10, 2004; about 103,000 Nov 16, 2009 immunotherapeutics:
ImVacS August 13-16, 2012 •
Cambridge, MA Program | Register | Download Brochure
Refers to any approach aimed at mobilizing or manipulating
a patient's immune system to treat or cure disease. Although the term has been
most often associated with therapies for established malignancies, immunotherapy
is of increasing interest as an approach to arrest cancer at a much earlier
stage. In addition as illustrated in the accompanying articles, immunotherapy is
pertinent to the investigation and treatment of transplantation, autoimmunity,
chronic inflammation, and infectious disease. Ralph M Steinman and Ira Mellman,
Immunotherapy; Bewitched, Bothered and Bewildered No more. Science 305: 197-
200, 9 July 2004
The concept of using the
immune system to treat disease, for example, developing a vaccine against
cancer. Immunotherapy may also refer to the therapy of diseases caused by the
immune system, allergies for example. [NHGRI]
Manipulation of the
host's immune system in treatment of disease. It includes both active and
passive immunization as well as immunosuppressive therapy to prevent graft
rejection. MeSH, 1973 Google = about 305,000
June 10, 2004; about 713,000 Nov 13, 2009
immunotoxins:
Semi-synthetic conjugates of various toxic molecules, including radioactive
isotopes and bacterial or plant toxins, with specific immune substances such as
immunoglobulins, monoclonal antibodies, and antigens. The antitumor or antiviral
immune substance carries the toxin to the tumor or infected cell where the toxin
exerts its poisonous effect. MeSH, 1990
Broader term:
antibodies
ligand: Drug &
disease Targets ligand binding
assays: Assays
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/
monoclonal
antibodies: Approximately 286 monoclonal
antibodies are in various stages of clinical development. Oncology is the area
of greatest activity, with approximately 150 new monoclonal antibodies in the
clinic for cancer indications. Some 70 monoclonal antibodies are in clinical
development for treatment of inflammatory and autoimmune diseases. Monoclonal
antibodies in clinical development for other indications include 15 products for
treatment of various metabolic disorders, 16 for CNS disorders, and 25 for
infectious diseases. A further 10 are in development for treatment of
cardiovascular diseases or transplant rejection. Monoclonal Antibodies in the
Pipeline: A Segment of Major Growth discusses emerging technologies to improve
the therapeutic characteristics of monoclonal antibodies. As injection is likely
to remain the delivery route, the focus is on trying to ensure subcutaneous
delivery while minimizing injection-site events and dosing frequency. PEGylation
is seen as one of the simplest methods to enhance the pharmacokinetic properties
of an antibody and alter its formulation properties. Therapeutic modification is
being effected by efforts to improve the design of antibody conjugates and
develop dual-specificity antibodies. Insight Pharma Reports Monoclonal
Antibodies in the Pipeline: A Segment of Major Growth 2011
Translational Strategies for Development of Monoclonal
Antibodies DVD
April 6, 2009 • 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
naked DNA: DNA
naked DNA vaccines:
NIAID,
NIH, Division of AIDS, Naked DNA Vaccines http://www.niaid.nih.gov/daids/vaccine/dna.htm
NME New Molecular Entity:
Regulatory Affairs
novel
constructs:
Understanding the activity of novel constructs in animal models
and clinical studies is critical to their success. There are numerous
constructs of bispecific and multiclonal antibodies, antibody-drug conjugates,
and antibody fragments heading to the clinic that are diverse in nature.
This conference will delve into tools for understanding effects in humans and
engineering for optimal efficacy, safety and metabolism, and strive to uncover
the link between immunogenicity and pK/pD. Determining PK/PD of
Novel Constructs October
10-12, 2012 • Bethesda, MD Program | Register | Download Brochure PEGS: the essential protein engineering summit April
30 - May 4, 2012 • Boston, MA Program | Register | Download Brochure PepTalk
2013 January 21-25, 2013 • Palm Springs, CA Program | Register | Download Brochure
peptide receptors:
Cell surface receptors that bind peptide
messengers with high affinity and regulate intracellular signals which
influence the behavior of cells. MeSH, 1994 peptidomimetic
A compound containing non-
peptidic structural
elements that is capable of mimicking or antagonizing the biological action(s)
of a natural parent peptide. A peptidomimetic does no longer have classical
peptide characteristics such as enzymatically scissille peptidic bonds. (See
also peptoids). [IUPAC Medicinal Chemistry] Related terms: -Omes &
-omics peptidome,
peptidomic
peptoid:
A peptidomimetic that results from
the oligomeric assembly of N-substituted glycines. [IUPAC Medicinal Chemistry]
phage display:
Protein technologies See also
antibody libraries protein
aggregation
Bioprocessing
protein
device combinations: Integrating protein formulations with parenteral
administration devices Protein-Device Combinations January
12-13, 2011 • Coronado, CA Program | Register | Download Brochure Order CD
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
Although small molecules (which allow
oral delivery) are preferred for drugs, a number of therapeutic proteins
are available, and the number has increased with progress in biotechnology and
genetic engineering. Important commercial products include insulin, monoclonal
antibodies, growth factors, and various blood and plasma
proteins. Related terms: antibody therapeutics, peptide
therapeutics, protein aggregation
recombinant
antibodies: As
new recombinant DNA technology continues to join with cellular and molecular
immunology, the field of antibody engineering has become a flourishing
discipline. Antibody genes are now being cloned, genetically manipulated, and
expressed to produce antigen binding proteins. Recombinant Antibodies, Wiley
1999 http://www.wiley.com/WileyCDA/WileyTitle/productCd-0471178470.html
recombinant therapeutics:
: The formation of
new combinations and arrangements of genes during meiosis; recombination
is achieved by crossing over, independent assortment, and segregation. NHLBI
reverse vaccinology: Today,
the possibility of using genomic information allows us to study vaccine
development in silico, without the need of cultivating the pathogen. This
approach, which we have named 'reverse vaccinology', reduces the time required
for the identification of candidate vaccines and provides new solutions for
those vaccines which have been difficult or impossible to develop. Rappuoli
R. Reverse vaccinology, a genome- based approach to vaccine development,
Vaccine. 19 (17-19) 2688- 2691, Mar 21, 2001 Wikipedia http://en.wikipedia.org/wiki/Reverse_vaccinology
vaccine:
An agent containing antigens produced from killed, attenuated
or live pathogenic microorganisms, synthetic peptides or by recombinant
organisms, used for stimulating the immune system of the recipient to produce
specific antibodies providing active immunity and/or passive immunity in
the progeny. IUPAC Compendium
Suspensions of killed or attenuated microorganisms (bacteria, viruses, fungi, protozoa, or rickettsiae), antigenic proteins derived from them, or synthetic constructs, administered for the prevention, amelioration, or treatment of infectious and other diseases.
MeSH Narrower
terms: allogeneic polyvalent vaccines, allogenic vaccines, autologous vaccines, DNA vaccine; Related terms: reverse vaccinology; -Omes & -omics: vaccinome,
vaccinomics Novel Vaccines August 13-15, 2012 • Cambridge, MA Program | Register | Download Brochure vaccine
ontology:
http://www.violinet.org/vaccineontology/
vaccine quality:
This
event brings together specialists from Process Development, Analytical
Characterization, CMC, and Regulatory Strategy amongst others to examine the
important interface between the process, vaccine characterization, and
interaction with the regulatory authorities. Attendees will discover how the
experts adapt the process and set up panels of characterization tests for robust
potency assays, physicochemical characterization, and for release. We plan to
cover all stages of development, a range of prophylactic areas, a selection of
cell lines and a variety of vaccines. vaccines:
An analytical snapshot of the current state of the vaccine industry, its
development efforts, and an outlook to 2020. New Trends in Preventive and
Therapeutic Vaccines October 2011 Table of
Contents | Tables and
Figures |Executive
Summary
yeast
display: Phage
and Yeast Display April
30 - May 1, 2012 • Boston, MA Program | Register | Download
Brochure Bibliography
HHS Vaccines acronyms http://www.vaccines.gov/more_info/acronyms/index.html IUPAC
definitions are reprinted with the permission of the International Union of Pure
and Applied Chemistry.
Evolving Terminology for Emerging Technologies
Comments? Questions?
Revisions? Mary Chitty mchitty@healthtech.com
Last revised December 12, 2012
View a Printer-Friendly Version of this Web Page!
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Making and using antibodies,
John Wagner's Logic of Molecular Approaches to Biological Problems (Cornell
Univ. Graduate School of Medical Science, US ) has a section explaining what a powerful technology this is. http://www-users.med.cornell.edu/~jawagne/Antibody_Approaches.html
Antibody Resource Page, http://www.antibodyresource.com/index.html
Monoclonal
Antibodies & Therapies, Nature,
2004 http://www.nature.com/focus/antibodies/


Antibodies for the 21st Century January
11-12, 2012 • Coronado, CA Program | Register | Download
Brochure
Much
work has also been done on altering antibodies’ outward form to boost their
efficacy, enabling them to more readily penetrate tumors, enhancing their
ability to stimulate beneficial immune responses, or otherwise improving their
characteristics. Into this realm fall such constructions as antibody fragments,
diabodies, synthetic antibodies, bispecific antibodies, and antibody conjugates.
This report looks at some of the engineered forms of antibodies and the
companies that are leading the way in this research. Other complementary
technologies, such as PEGylation and glycosylation, are also presented.
Insight Pharma Reports, Monoclonal
Antibodies: Pipeline Analysis and Competitive Assessment 2009
antibody optimization: Antibody Optimization May 3-4, 2012 • Boston, MA
Program | Register | Download Brochure

Antibodies direct the immune system to a specific
molecular target in the body, and because they are so specific, offer an
improved safety margin over existing small molecule treatments for cancer and
other diseases. Xencor, XmAb® Antibody therapeutics, 2005 http://www.xencor.com/products-xmab.html
Related terms: antibody drug products, monoclonal
antibodies, protein
therapeutics

bispecific
antibodies: Upsurge of Bispecific Antibodies May 2-3, 2012 • Boston, MA Program | Register | Download
Brochure
Empowered
Bispecific Antibodies and Antibody-Drug Conjugates October
6-7, 2010 • Hannover Germany PEGS
Europe Program | Register
| Download Brochure

biotechnology: The integration
of natural sciences and engineering sciences in order to achieve the application
of organisms, cells, parts thereof and molecular analogues for products
and services. IUPAC Compendium

domain antibodies:
The smallest known antigen- binding fragments of antibodies, ranging from 11 kDa
to 15 kDa. ... owing to their small size and inherent stability, can be
formatted into larger molecules to create drugs with prolonged serum half- lives
or other pharmacological activities. LJ Holt et. al, Domain Antibodies: Proteins
for Therapy, Trends in Biotechnology, 21 (11): 484- 490, Nov. 2003
An evolving technique used to treat inherited diseases.
The medical procedure involves either replacing, manipulating, or supplementing
nonfunctional genes with healthy genes. [NHGRI]
Cellular & gene therapy,
FDA, US http://www.fda.gov/cber/gene.htm
FDA has not yet approved any human gene therapy product for sale. However, the
amount of gene-r elated research and development occurring in the United States
continues to grow at a fast rate and FDA is actively involved in overseeing this
activity. 2009
Related terms:
human gene transfer, genetic enhancement; DNA glossary:
recombinant DNA Molecular diagnostics &
genetic testing:
especially preimplantation diagnosis

immunotherapy:
Applications of
immunotherapies and vaccines for prevention and treatment of infectious diseases
and cancer are well known. Research and development of immunotherapies for other
indications has been progressing for many years, although this effort has not
received the public attention that the work on infectious disease and cancer
immunotherapies and vaccines has. Immunotherapies
being developed or used for treatment of other diseases (i.e., beyond prevention
and treatment of infectious diseases and cancer) are the focus of this report.
These may work by different mechanisms of action, and available information
regarding how these immunotherapies work is presented. Each chapter focuses on
one disease or disease category, which include Alzheimer’s disease, cocaine
and nicotine addiction, other neurology applications including pain,
cardiovascular diseases including thrombosis, hematology/blood disorders,
ophthalmology, osteoporosis and other bone metabolism disorders, type 2
diabetes, and other (general) applications of immunotherapies. Insight Pharma
Reports, Immunotherapies
and Vaccines for Nontraditional Indications 2009
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


peptide
therapeutics: As potential
therapeutics, peptides offer several advantages over small molecules (increased
specificity) and antibodies (small size). However, delivery and sensitivity to
serum and tissue proteases coupled with short serum half-life have remained
major therapeutic stumbling blocks. Peptide
Therapeutics January 14-15, 2010 • Coronado, CA Program Order
CD
polyclonal antibodies:
A mixed population of antibodies that
recognize numerous epitopes. HIV Plus 9, June- July 2000 http://www.aidsinfonyc.org/hivplus/issue9/report/glossary.html
protein
therapeutics:
By 2020, the current renaissance of biotechnology will have resulted in a broad
range of products that will, almost without exception, involve a degree of
protein engineering. This report discusses new developments in therapeutic
protein engineering and developments that are likely to occur through 2020. Engineering Next-Generation
Therapeutic Proteins July 2011 Table of
Contents | Tables and
Figures

Recombinant Protein Therapeutics
January 10-11, 2011 • Coronado, CA
Program | Register
| Download Brochure Order CD
Part of
PEP Talk January 10-14,
2011 • Coronado, CA Program
| Register
| Download Brochure 
therapeutic antibodies: Antibodies and related
products are the fastest growing class of therapeutic agents. By analysing the
regulatory approvals of IgG-based biotherapeutic agents in the past 10 years, we
can gain insights into the successful strategies used by pharmaceutical
companies so far to bring innovative drugs to the market. Many challenges will
have to be faced in the next decade to bring more efficient and affordable
antibody-based drugs to the clinic. Here, we discuss strategies to select the
best therapeutic antigen targets, to optimize the structure of IgG antibodies
and to design related or new structures with additional functions.
Vaccine Research publications, National Institute of Allergies &
Infectious Diseases, NIH, US http://www.niaid.nih.gov/publications/vaccine.htm
vaccine development preclinical/clinical: Join the leaders of vaccine
development as they address the clinical challenges facing therapeutic vaccine
development, including patient selection, international outsourcing for trial
completion, and navigating regulatory approval. Clinical development of these
products includes the use of novel clinical trial designs, identification of
patient populations as well as addressing regulatory concerns.
Pre-Clinical/Clinical
Development of Vaccines August 17-18, 2011 • Cambridge, MA Program
| Register
| Download Brochure
vaccine development
novel: Vaccine leaders from around the world will once again
come together to discuss critical issues surrounding the development of
effective – and affordable – vaccines at the Seventh Annual Novel Vaccines
meeting. Day One will explore innovative approaches to conquering infectious
diseases including Hepatitis, Dengue Fever and Influenza. Day Two will be
devoted to “the Big 3” – HIV, Malaria and Tuberculosis – and the
highlighted Plenary Session on Day Three will explore predicting immune response
through emerging technologies such as Systems Biology approaches.

See also antibody libraries
Biologics Conferences http://www.healthtech.com/Conferences/Search.aspx?k=&r=&s=PTTS
Biologics CDs, DVDs http://www.healthtech.com/Conferences/Search.aspx?k=&r=&s=PTTS
Biologics Short courses http://www.healthtech.com/Conferences_Upcoming_ShortCourses.aspx?s=PTTS
Immunotherapeutics & Vaccines ImVacS
http://www.chicorporate.com/imt/overview.aspx?c=6785
Molecular Medicine Tri Conference http://www.triconference.com/
PepTalk The Protein Science Week http://www.chi-peptalk.com/
Protein Engineering Summit PEGS http://www.pegsummit.com/
Insight Pharma Reports Biologics Series http://www.insightpharmareports.com/Reports/All.aspx?s=PTTS
Insight Pharma Reports, Immunotherapies
& Vaccines for Cancer & Infectious Diseases, 2008
Insight Pharma
Reports, Immunotherapies
and Vaccines for Nontraditional Indications 2009
Insight Pharma Reports,
Monoclonal Antibodies in the Pipeline, 2011
HHS, Vaccines Glossary http://www.vaccines.gov/more_info/glossary/
IUPAC
International Union of Pure and Applied Chemistry, Compendium of Chemical
Terminology: Recommendations, compiled by Alan D. McNaught and Andrew
Wilkinson, Blackwell Science, 1997. "Gold Book" 6500+
definitions. http://goldbook.iupac.org/
IUPAC, Glossary of terms related to pharmaceutics, Pure and
Applied Chemistry 81, 971–999, 2009, 168 definitions
MeSH Medical Subject Headings, PubMed http://www.ncbi.nlm.nih.gov/mesh
NFCR Center for
Therapeutic Antibody Engineering Glossary
,
National Foundation for Cancer Research, Dana Farber Cancer Institute http://research.dfci.harvard.edu/nfcr-ctae/research/tech_glossary.php
Alpha
glossary index
How
to look for other unfamiliar terms