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Biologics: antibodies, protein therapeutics & vaccines glossary & taxonomy
Evolving Terminology for Emerging Technologies
Comments? Questions? Revisions?  Mary Chitty
Last revised December 19, 2014
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adjuvants  Drug delivery  vaccines

adoptive T Cell therapy: Adoptive T Cell Therapy    Adoptive T cell therapy has the potential to increase antitumor immunity, enhance vaccine efficacy, and limit graft-versus-host disease (GVHD). Recent advances in protein engineering and molecular biology have increased the feasibility of using genetically engineered T cells to treat disease, leading to an influx of new discoveries and techniques. Adoptive T Cell Therapy  May 6-7, 2015 • Boston, MA Program | Register | Download Brochure 

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,. 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.
Antibody Resource Page
Monoclonal Antibodies & Therapies
, Nature, 2004 

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 binding: Enhancing Antibody Binding and Specificity  January 21-22, 2015 • San Diego, CA Program | Register | Download Brochure

Enhancing Antibody Binding and Specificity

antibody drug conjugates: Antibody-Drug Conjugates January 21-22, 2015 • San Diego, CA Program | Register | Download Brochure
Characterization of ADCs, Bispecifics and New Biotherapeutics
 January 19-20, 2015 • San Diego, CA Program | Register | Download Brochure 

Engineering ADCs  May 6-7, 2015 • Boston, MA Program | Register | Download Brochure    ADCs: Preclinical and Clinical Updates May 7-8, 2015 • Boston, MA Program | Register | Download Brochure
Engineering ADCs

Antibody-drug conjugates offer the promise of delivering more powerful tumor-killing activity while resulting in diminished side effects for cancer patients. ADCs are precise and selective by combining a targeted monoclonal antibody (or antibody fragment) linked to a potent anti-cancer therapeutic. 
companies entering this space has grown as a result.

antibody engineering: The field of engineering antibody therapeutics continues to show significant growth with an increasing number of clinical achievements being witnessed.
Engineering AntibodiesEngineering Antibodies May 6-7, 2015 • Boston, MA 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  

NFCR Center for Therapeutic Antibody Engineering Glossary , National Foundation for Cancer Research, Dana Farber Cancer Institute 

antibody therapeutics: Related terms: 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:  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, 

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 

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.  

Include blood, vaccines, tissue, allergenics and biological therapeutics.

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    

biosimilars:  See  Regulatory Affairs

bispecific antibodies: Creating bioactive molecules that are multivalent and multifunctional offers the promise of more effective therapeutics. By binding to at least two molecular targets simultaneously, antibodies are empowered, thereby delivering a highly potent therapeutic, particularly for cancer immunotherapy.    

Hybrid, artificially produced antibodies in which each of two antigen-binding sites is specific for separate antigenic determinants. Nature Glossary  
Bispecific Antibody Therapeutics
Bispecific Antibody Therapeutics January 22-23, 2015 • San Diego, CA Program | Register | Download Brochure

Engineering Bispecific Antibodies
  May 7-8, 2015 • Boston, MA 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

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      Related terms: Business of biotechnology biotechnology firms, biotechnology industry 

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  Related terms: gene therapy, myoblasts, stem cells; Cancer  cancer vaccines See also high content assays  Stem cells

clinical efficacy antibodies: When the more than 350 therapeutic monoclonal antibodies in development advance into the clinic and to commercial launch, the quality of therapeutic response will become increasingly important to regulatory agencies and frugal payers. Regulators are demanding better data to support claims of safety and potency – and payers are seeking meaningful therapeutic benefits relative to existing standards of care before adding higher-cost biotherapeutics to formularies.   Improving the Clinical Efficacy of Antibody Therapeutics
Improving the Clinical Efficacy of Antibody Therapeutics January 22-23, 2015 • San Diego, CA Program | Register | Download Brochure 

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

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  linear epitopes Wikipedia   Also known as discontinuous epitopes.  Mimotopes Wikipedia 

epitope mapping: Maps, genomic & genetic

formulation biologics: Drug delivery

fusion proteins: Fusion Protein Therapeutics  May 4-5, 2015 • Boston, MA Program | Register | Download Brochure
Fusion Protein Therapeutics

gene therapy:
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 covers both the research and clinical applications of the new genetic therapy techniques currently being developed. Over the last decade, gene therapy protocols have entered clinical trials in increasing numbers and as they cover a wide spectrum of diseases, these studies promise to unite the diverse organ-based specialties into which modern medicine has become divided. Gene Therapy covers all aspects of gene therapy as applied to human disease, including: novel technological developments for gene transfer, control and silencing, basic science studies of mechanisms of gene transfer and control of expression, preclinical animal model systems and validation studies, clinical trial reports which have significant impact for the field, gene-based vaccine development and applications, cell-based therapies including all aspects of stem cells and genetically modified cellular approaches. Aims and Scope, Gene Therapy, Nature

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  

Cellular & gene therapy, 
FDA, US 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

immunogen: A substance that elicits a cellular immune response and/ or antibody production (cf. antigen). IUPAC Compendium

immunogenicity: Drug safety

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   

immunotherapeutics: ImVacS: The Immunotherapies and Vaccines SummitImVacS: The Immunotherapies and Vaccines Summit  August 11-13, 2014 • Boston, MA Program | Register | Download Brochure

August 24-27, 2015 at the Marriott Long Wharf in Boston, MA

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 

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 

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

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 

NME New Molecular Entity: Regulatory Affairs

novel constructs: Understanding the metabolism of novel constructs in animal models and clinical studies is critical to their success. This year’s conference will cover the role of PK in optimizing novel constructs, look at opportunities for improvement of antibody-drug conjugates, share examples of implementing mechanistic modeling to inform drug design, and review the state-of-the-art techniques for applying multi-specific medicines.   
PEGS: the essential protein engineering summit	PEGS: the essential protein engineering summit  May 4-8, 2015 • Boston, MA Program | Register | Download Brochure

PEGS Summit China 2015PEGS Summit China 2015  March 31 - April 2, 2015 • Shanghai China Program | Register | Download Brochure

PEGS EuropePEGS Europe  2014 Nov 3-7, Lisbon Portugal 
PepTalkPepTalk  January 19-23, 2015 • San Diego, 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

peptide therapeutics:
By 2018, the global Peptide Therapeutics market is expected to reach over $25 billion.  This dramatic market increase is driven by both growing incidences of cardiovascular and metabolic diseases, and technological enhancements in peptide synthesis that include high-throughput approaches.  Conjugation technologies are also contributing to the growth of peptide therapeutics, and leading to innovative approaches to designing safe and effective therapies.     
Peptide Therapeutics
Peptide Therapeutics  May 6-7, 2015 • Boston, MA Program | Register | Download Brochure

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  

polyclonal antibodies:
A mixed population of antibodies that recognize numerous epitopes. HIV Plus 9, June- July 2000  

primary and secondary antibodies: Wikipedia

protein aggregation Bioprocessing

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 

Recombinant Protein TherapeuticsRecombinant Protein Therapeutics January 19-20, 2015 • San Diego, CA Program | Register | Download Brochure

recombination : 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 

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.  

Following lead selection, an antibody drug candidate will navigate a complex path of steps leading to its readiness for an IND approval, first in man clinical studies and then ultimately its maturity into a drug product appropriate for phase 3 trials and commercial use. New disease indications, multispecific targeting and conjugates bring new challenges to preclinical studies, and the industry continues to push for new screening and design approaches that will accelerate and reduce the cost of antibody drug development. 

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

vaccine ontology:

vaccines: ImVacS  August 24-27, 2015 at the Marriott Long Wharf in Boston, MA 

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  

Biologics Conferences
Biologics CDs, DVDs
Biologics Short courses
Immunotherapeutics & Vaccines ImVacS
Molecular Medicine Tri Conference
PepTalk The Protein Science Week
Protein Engineering Summit PEGS

Insight Pharma Reports Biologics Series

HHS Vaccines acronyms 
HHS, Vaccines 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.  
IUPAC, Glossary of terms related to pharmaceutics, Pure and Applied Chemistry 81, 971–999, 2009, 168 definitions
MeSH Medical Subject Headings, PubMed 
NFCR Center for Therapeutic Antibody Engineering Glossary , National Foundation for Cancer Research, Dana Farber Cancer Institute 

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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