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Biologics: antibodies, protein therapeutics & vaccines glossary & taxonomy
Evolving Terminology for Emerging Technologies
Comments? Questions? Revisions?  Mary Chitty 
mchitty@healthtech.com
Last revised December 12, 2012
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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 
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/ 

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
Novel Antibody Constructs & Alternative Scaffolds

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 Program | Register | Download Brochure
Therapeutic Developments with Novel Antibody Products
Antibodies for the 21st Century
 January 11-12, 2012 • Coronado, CA Program | Register | Download Brochure
Antibodies for the 21st Century

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


Therapeutic and diagnostic antibodies continue to make 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. 

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  

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  


antibody optimization: Antibody Optimization May 3-4, 2012 • 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   Order CD 

Development of Antibody-Based Therapeutics DVD May 16, 2010
Antibodies for the 21st Century
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 

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 Biologics Partnering Forum: Emerging Antibody and Protein Engineering

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   See also Regulatory Affairs

bispecific antibodies: Upsurge of Bispecific Antibodies May 2-3, 2012 • Boston, MA Program | Register | Download Brochure

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.   

Empowered Bispecific Antibodies and Antibody-Drug Conjugates
 October 6-7, 2010 • Hannover Germany  PEGS Europe  Program | Register | Download Brochure  

Bispecific Antibody Therapeutics January 12-13, 2012 • Coronado, CA Program | Register | Download Brochure
Bispecific Antibody Therapeutics

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 

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

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

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

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
An evolving technique used to treat inherited diseases. The medical procedure involves either replacing, manipulating, or supplementing nonfunctional genes with healthy genes. [NHGRI]

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

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

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 ImVacS

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

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 •

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 

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
PEGS: the essential protein engineering summit 	 

PepTalk 2013 January 21-25, 2013 • Palm Springs, CA Program | Register | Download Brochure   PepTalk 2013

peptide receptors: Cell surface receptors that bind peptide messengers with high affinity and regulate intracellular signals which influence the behavior of cells. MeSH, 1994

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

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

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 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
Protein-Device Combinations  
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

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 Protein Therapeutics  January 10-11, 2011 • Coronado, CA Program | Register | Download Brochure  Order CD   This meeting addressed the innovative strategies and supporting technologies that spur progress, including engineering the Fc regions.  Persistent challenges were  discussed, along with case studies of recombinant protein therapeutic products.  

Part of PEP Talk January 10-14, 2011 • Coronado, CA Program | Register | Download Brochure 
Recombinant Protein Therapeutics

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.  Strategies and challenges for the next generation of therapeutic antibodies., Beck A, Wurch T, Bailly C, Corvaia N., Centre d'Immunologie Pierre Fabre Nat Rev Immunol. 2010 May;10(5):345-52. http://www.ncbi.nlm.nih.gov/pubmed/20414207

recombinant therapeutics: : The formation of new combinations and arrangements of genes during meiosis; recombination is achieved by crossing over, independent assortment, and segregation. NHLBI  Can be natural or synthetic. Narrower terms:  genetic recombination,  recombinant antibodies, recombinant proteins  

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
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. 

Novel Vaccines August 13-15, 2012 • Cambridge, MA Program | Register | Download Brochure
Novel Vaccines  

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
See also antibody libraries

Bibliography
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 acronyms http://www.vaccines.gov/more_info/acronyms/index.html 
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

IUPAC definitions are reprinted with the permission of the International Union of Pure and Applied Chemistry.

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