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Biologics overview glossary & taxonomy 
Evolving Terminology for Emerging Technologies
Comments? Questions? Revisions?
Mary Chitty  MSLS
Last revised January 06, 2020

SCOPE NOTE Biologics are not new; development of human growth hormone, insulin, and red-blood cell stimulating agents occurred decades ago, but the targets have increased exponentially with new genetic information and new understanding of subcellular cascades and disease processes. Scientific fields used in developing biologics include genomics and proteomics, as well as microarray, cell culture, and monoclonal antibody technologies.  Defining the difference: What Makes Biologics Unique Thomas Morrow, MD and Linda Hull-Felcone, Biotechnol Healthc. 2004 Sep; 1(4): 24-26,28-29.  PMCID: PMC3564302

Biologics include vaccines gene therapies, cell therapies, Immuno-oncology, biosimilars, antibodies, antibody drug conjugates, bispecific antibodies.   See related glossariesBiologics: Antibodies & vaccines   Bioprocessing & Manufacturing   Cancer    Drug  Safety   Drug & Disease targets

Adoptive T Cell Therapy April 10-11, 2019 • Boston, MA Program | Novel gene editing technologies and a greater understanding of cancer biology could unleash the full power of CAR T in both blood and solid tumors. But which therapies will succeed?   CARTs, TCRs and TILs conference focuses on the latest research, protein engineering and clinical strategies driving the development of adoptive cell therapies across a wide range of indications. Clinical progress with Chimeric Antigen Receptors (CAR), T Cell Receptors (TCR), Tumor Infiltrating Lymphocytes (TIL), and NK cells will be addressed and new strategies for commercialization will be reviewed.

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   

Antibody Discovery Forum 2018 Sept26-27 Boston MA will focus on the discovery workflow, and explore best practices for identifying and using new and legacy technologies to discover novel and functional drug candidates in an environment where speed and efficiency is now a mandate. The meeting will consider new approaches to the essential steps in the discovery process and how to make these more efficient by selectively and intelligently integrating the many new tools now available on the market. A key focus of the agenda will be a discussion of methods used to discover well-performing candidates and leads as early as possible – and to accomplish this goal at the lowest possible cost needed to achieve a high-quality outcome.

Antibody-Drug Conjugates January 21-22, 2020 • San Diego, CA have demonstrated their ability to deliver cytotoxic small-molecule drugs through a selective and targeted mechanism in the fight against cancer. In recent years, ADCs have entered almost 600 clinical trials with more than 60 distinct ADC molecules currently under development. Despite the enormous promise, a low therapeutic index has plagued ADC development, particularly for treating solid tumors.

Antibody-drug conjugates  (ADCs) are defined as antibodies to which other molecules are bound through a chemical linker. The term “conjugate” differentiates these modified antibody forms from peptide fusions that may be genetically fused to N- or C-termini of either the light or heavy chains of the antibody. The general principle of ADCs is to use the antibody to target a particular cell population, thereby carrying the conjugated molecule to that targeted cell population so that it can exert most, if not all, of its pharmacological activity upon just that population. Science Direct, Medicine & Chemistry, Antibody Drug Conjugates

Antibody-drug Conjugates or ADCs are empowered antibodies (mAbs) designed to harness the targeting ability of monoclonal antibodies by linking them to cell-killing agents. An ideal ADC has: A highly selective monoclonal antibody (mAb) for a tumor-associated antigen that has restricted or no expression on normal (healthy) cells; A potent cytotoxic agent (generally a small molecule drug with a high systemic toxicity) designed to induce target cell death after being internalized in the tumor cell and released; A linker that is stable in circulation, but releases the cytotoxic agent in target cells.  ADC Review

ANTIBODY DRUG CONJUGATES 2019 April 10-11 BOSTON MA  By combining the selectivity of targeted treatment with the cytotoxic potency of chemotherapy drugs, ADCs hold the promise to revolutionize disease treatment, especially for cancer. However, the path toward ADC success is not without challenges. Using lessons learned from the past decade of ADC development, scientists are developing strategies for the third-generation antibody-drug conjugates by selecting the right target antigens, designing new payloads, optimizing linkers and engineering conjugation chemistries.

Antibody drug conjugates next generation 2018 Nov 12-13 Lisbon Portugal As more Antibody-Drug Conjugates head to market, the next-generation of ADCs looms on the horizon. Next-gen engineering requires designing an optimal antibody, payload, linker and conjugation method while ensuring stability, targeted delivery, and limited off-target effects.

Clinical Progress of Antibody-Drug Conjugates Advancing Novel ADC Platforms and Combinations to the Clinic APRIL 11-12, 2019 Boston MA  Antibody-drug conjugates (ADCs) continue to emerge as a strong and promising strategy for target cancer therapy. Today, there are four ADCs approved and commercially available in the US, with another 175 investigational ADCs in development, from early discovery to clinical phase III trials, across both hematologic malignancies and solid tumor indications. Some of these trials are single-agent trials, while others are combinations. Companies are leveraging on lessons learned from first and second-generation trials to inform on next-generation ADC designs.

ANTIBODY ENGINEERING: New Science and Technologies for the Selection, Engineering and Targeting of Next Generation Therapeutic Antibodies and Biotherapeutics  2019 April 10-11 Boston MA  The field of protein engineering is at an exciting point in its development, with new generations of therapeutic antibodies now progressing through development and into the market, great advances in protein science and discovery technology and a body of clinical evidence that can be used to inform the development of safe, highly effective therapies for unmet medical needs  Program

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

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 

biopharmaceutical: also known as a biologic(al) medical product, biological,
[1] or biologic, is any pharmaceutical drug product manufactured in, extracted from, or semisynthesized from biological sources. Different from totally synthesized pharmaceuticals, they include vaccinesblood, blood components, allergenicssomatic cellsgene therapiestissuesrecombinant therapeutic protein, and living cells used in cell therapy. Biologics can be composed of sugars, proteins, or nucleic acids or complex combinations of these substances, or may be living cells or tissues. They (or their precursors or components) are isolated from living sources—human, animal, plant, fungal, or microbial. Wikipedia accessed 2018 March 1

bispecific antibodies
A type of antibody that can bind to two different antigens at the same time. Bispecific antibodies are being studied in the imaging and treatment of cancer. NCI Dictionary of Cancer Terms 

Bispecific antibodies (bsAbs) combine specificities of two antibodies and simultaneously address different antigens or epitopes. BsAbs with ‘two-target’ functionality can interfere with multiple surface receptors or ligands associated, for example with cancer, proliferation or inflammatory processes. BsAbs can also place targets into close proximity, either to support protein complex formation on one cell, or to trigger contacts between cells.. Bispecific antibodies   Roland E.Kontermann1UlrichBrinkmann2  Drug Discovery Today Volume 20, Issue 7, July 2015, Pages 838-847

Bispecific Antibody Pipeline Congress  August 20-23, 2018 Alexandria, VA  Will unite all the key opinion leaders including regulators, clinicians, and industry experts to deepen our understanding of bispecific therapeutics and exchange innovative ideas to foster meaningful research collaborations. Our 3-day bispecific-focused meeting emphasizes new and unpublished insights that are not widely shared in the scientific community

Bispecific antibodies continue to show significant and impressive therapeutic value. While the development of bispecific antibodies is an evolving field, many challenges are still waiting to be solved by experts in the field, including target selection, heterodimerization, understanding of their mechanism of action, along with developability assessment and manufacturing concerns. Bispecific Antibody Design   August 20-21, 2018 Alexandria VA

Will bring together clinicians, regulators, and industry experts in the field to discuss and exchange ideas on promising bispecific candidates. We will showcase all crucial topics from understanding the biology behind different bispecific constructs to mitigating challenges in advancing novel platforms to the clinic. A companion diagnostic aspect for bispecific platforms will also be examined for meaningful therapeutic selection based on patient identification, stratification, and the early assessment of treatment efficacies. Other applications of bispecifics beyond oncology will also be discussed.  Bispecific Antibody Case Studies & Clinical Relevance August 22-23, 2018 Alexandria VA 

Engineering Bispecific Antibodies Engineering Bispecific Antibodies Improving Therapeutic Properties for Oncology and Beyond  April 11-12,  2019 • Boston, MA   The world of bispecific strategies, formats and clinical results has been gearing up over the past several years. Now in its tenth year, the Engineering Bispecific Antibodies conference was the first one in the community to address the vast challenges and exciting new engineering and manufacturing advances that are enabling the next generation of improved bispecific antibodies. Come see for yourself why this field misleading a transformation beyond oncology to many other areas of medicine.

Bispecific Antibody Therapeutics January 23-24, 2020, San Diego   explores the challenges of engineering multi-specificity to achieve more effective therapies that bind to at least two molecular targets simultaneously. These next-generation antibody formats are showing efficacy in the efforts to conquer cancer and other diseases. Case studies will highlight novel engineering approaches that address safety, stability, enhanced targeting, and manufacturability.

Bispecifics & combination therapy: Advancing Bispecifics and Combination Therapy to the Clinic 2018 Nov 14-15 Lisbon Portugal features case studies for haematological and solid tumours, bispecific-like products and biotherapeutics in combination. Presenters explain the rationale for the choice of combination, the background to the mode of action and how the products perform, as well as PK profile, PK/PD relationships, safety/toxicology studies, getting the right potency: side effect balance, translational studies, and risk assessment. Where appropriate, investigators present clinical trial design, demonstration of safety, issues that have arisen and have been resolved, proof of concept, dose escalation studies, and interaction with clinicians.

CAR T, TIL and TCT therapy 2018 Nov 14-15 Lisbon Portugal in the past year, the CAR T-cell therapy field has heated up considerably with two recently approved therapies, Kymriah™ and Yescarta™. Efforts to design CAR, TCR and TILs with greater targeting precision, safety profiles and efficacy are leading to a new generation of improved products that will continue to propel the field forward.  Learn engineering updates, clinical progress and streamlined manufacturing that promise to greatly advance T-cell therapies forward.

CAR Ts, TCRs and TILs Latest Innovations and Developments in Adoptive Cell Therapy APRIL 10-11, 2019 Boston MA  Program   Novel gene editing technologies and a greater understanding of cancer biology could unleash the full power of CAR T in both blood and solid tumors. But which therapies will succeed? Cambridge Healthtech Institute’s Sixth Annual CARTs, TCRs and TILs conference focuses on the latest research, protein engineering and clinical strategies driving the development of adoptive cell therapies across a wide range of indications. Clinical progress with Chimeric Antigen Receptors (CAR), T Cell Receptors (TCR), Tumor Infiltrating Lymphocytes (TIL), and NK cells will be addressed and new strategies for commercialization will be reviewed.  Coverage will include, but is not limited to: New understandings of T cell receptors – turning cold tumors hot, Understanding the mechanism of treatment failure, Progress in: Chimeric Antigen Receptors (CAR), including gene edited CAR Ts, Tandem CARs, T Cell Receptors (TCR), Tumor Infiltrating Lymphocytes (TIL), Next-generation CAR Ts, Other subtypes NK Cells, TRegs, Gamma Deltas

cell culture refers to the removal of cells from an animal or plant and their subsequent growth in a favorable artificial environment. The cells may be removed from the tissue directly and disaggregated by enzymatic or mechanical means before cultivation, or they may be derived from a cell line or cell strain that has already been established. Introduction to Cell Culture, Thermo Fisher

Display of Antibodies  2019 April 8-9 Boston MA showcases innovation in discovery, design and engineering of biologics through molecular evolution using phage, yeast and other display methodologies. The proliferation of novel constructs is possible through methods to improve library design, pharmacological and biophysical properties to create drug molecules with greater potency, modes of action, target specificity and activity than previously achievable.    Related terms: phage display, yeast display

formulation, pharmaceutical: in pharmaceutics, is the process in which different chemical substances, including the active drug, are combined to produce a final medicinal product. The word formulation is often used in a way that includes dosage form. Formulation studies involve developing a preparation of the drug which is both stable and acceptable to the patient. Wikipedia

Fusion proteins and beyond  Recombinant Protein Therapeutics  January 20-21, 2020 • San Diego, CA |  focuses on the varying designs of fusion protein-based therapeutics and the latest data from R&D to post-approval, including Case Studies. By combining modular building blocks that can reach targets not accessible to antibodies, Fusion Protein Therapies possess advantages over antibody-based therapies; their customizable functionality translates into lower patient dosing, reduced production costs, and improved product homogeneity. This conference will demonstrate how these molecules are being engineered to form more efficacious therapeutics that offer specificity with enhanced stability and longer half-life

fusion protein therapeutics: Engineering for Clinical Success APRIL 8-9, 2019 Boston MA  Program Chimeric fusion proteins, with their ability to extend plasma half-life and prolong therapeutic activity, offer exciting benefits over antibody-based therapeutics. Companies are intensely investigating into fusion protein therapeutics as a promising alternative to antibodies. See also recombinant proteins

Defined as a multifunctional protein derived from a single nucleotide sequence which may contain 2 or more genes or portions of genes with or without amino acid linker sequences. The genes should originally code for separate proteins, both with pharmacological action (e.g., action and targeting).

gene therapy: an experimental technique that uses genes to treat or prevent disease. In the future, this technique may allow doctors to treat a disorder by inserting a gene into a patient’s cells instead of using drugs or surgery. Researchers are testing several approaches to gene therapy, including: Replacing a mutated gene that causes disease with a healthy copy of the gene, Inactivating, or “knocking out,” a mutated gene that is functioning improperly, Introducing a new gene into the body to help fight a disease/ Although gene therapy is a promising treatment option for a number of diseases (including inherited disorders, some types of cancer, and certain viral infections), the technique remains risky and is still under study to make sure that it will be safe and effective. Gene therapy is currently being tested only for diseases that have no other cures. Genetics Home Reference, NIH National Library of Medicine

immunogenicity: is the ability of a particular substance, such as an antigen or epitope, to provoke an immune response in the body of a human or animal. In other words, immunogenicity is the ability to induce a humoral and/or cell-mediated immune responses.  accessed 2017 Oct 16

Immunogenicity Assessment and Regulatory Approval of Biologics Achieving Assay Quality and Clinical Success of Novel Biologics APRIL 10-11, 2019 BOSTON MA Immunogenicity has always been a critical safety concern, especially when many biotherapeutics are becoming increasingly complex. Understanding and controlling immunogenicity-related risks are essential in the development of biotherapeutics to ensure meeting the regulatory requirements. The 12th Annual Immunogenicity Assessment and Regulatory Approval of Biologics conference brings industry, regulatory and scientific experts together to share best practices in assessing immunogenicity of novel biologics along with biosimilar products. The session will also discuss the challenges and solutions for addressing new regulatory guidelines in assay development and validation for cell and gene therapies.

Immunogenicity Case Studies and Clinical Management Interpretation and Understanding of Immunogenicity Data in Clinical Settings APRIL 8-9, 2019 BOSTON MA As the immunogenicity field is moving forward, closing the gap between clinicians and assay developers is essential in the success of biologic development and accelerates the adoption of new biologic therapies in patient treatments. This year, CHI’s Immunogenicity Case Studies and Clinical Management conference will focus on new case studies of novel biologics and emphasize on closing this gap by providing multiple viewpoints from clinicians, technology developers and regulators on how to use immunogenicity data in clinical settings.

Lead Optimization for Drug Metabolism and Safety April 12, 2019 San Diego, CA Program | The more chemists know about how the structure of a compound can possibly impact its drug-like properties, the faster they can optimize it for drug development. Lead compounds in drug discovery need to be optimized for both efficacy and safety. Unfortunately, some of the adverse events related to the compound do not surface until much later in development… will introduce chemists to some key concepts in biotransformation, drug metabolism, drug transport, and drug clearance using relevant case studies and research findings.

monoclonal antibodies: 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

Development of Therapeutic Monoclonal Antibody Products A Comprehensive Guide to CMC Activities from Clone to Clinic  Insight Pharma Reports 2017 As the pharmaceutical market in the United States and the rest of the world continues to expand, biopharmaceutical products have taken on increasing importance in the treatment of disease. Sales of monoclonal antibody products have grown from approximately $50 billion in 2010 to almost $90 billion in 2015, an approximately 1.8‑fold increase and represent approximately 58% of biopharmaceutical sales.  As more and more exciting monoclonal antibody products for treatment of cancer, autoimmune diseases, cardiovascular disease, and others are introduced, sales from new products approved in the coming years will drive the world-wide sales of monoclonal antibody products to approximately $110 billion by 2018 and nearly $150 billion by 2021.

Oligonucleotide & Precision Therapeutics  March 26-28, 2019 Cambridge, MA Program advances in next-generation oligonucleotide therapies throughout the drug development process.

Oligonucleotide CMC & Regulatory Boston  March 26-28, 2019 Cambridge, MA  Program |  sessions on new chemistries, novel delivery mechanisms and the most important preclinical and clinical advances. Leading oligonucleotide scientists deliver detailed case studies on antisense, RNA, aptamer and oligonucleotide conjugates

Oligonucleotide Discovery & Delivery  March 26-27, 2019 Cambridge, MA  Program | detailed case studies on antisense, RNA, aptamer and oligonucleotide conjugates  .

PEGS: the essential protein engineering summit PEGS: the essential protein engineering summit   Program May 4-5, 2020 • Boston, MA Conference programs include protein and antibody engineering, cancer immunotherapy, oncology, and emerging therapeutics.

PEGS Europe PEGS Europe  2019 Nov Lisbon Portugal Conference programs include Engineering, Oncology, Analytical, Immunotherapy, Expression and Bispecifics.

PepTalk  January 2020 • San Diego, CA Program | Conference programs include Protein Engineering and Development, Innovations in Discovery and Development, Antibody Therapeutics,  Formulation and Stability, Analytics & Impurities, Process Technologies & Purification, Biotherapeutic expression & production, Alternative expression & products 


phage display: Use of genetically engineered phage to present peptides as segments of their native surface proteins. Peptide libraries may be produced by populations of phage with different gene sequences. IUPAC Combinatorial Chemistry  Broader term: display technologies  Related terms:  bacteriophage, biopanning, phage

protein aggregation: a biological phenomenon in which mis-folded proteins aggregate (i.e., accumulate and clump together) either intra- or extracellularly. These protein aggregates are often correlated with diseases. Wikipedia accessed 2019 June 24

Protein aggregation and stability in Biopharmaceutical Products 2019 May 3-4 Boston MA The phenomenon of protein aggregation is a complex conundrum that impacts biopharmaceutical development at virtually every stage. All mechanisms of aggregation are not conclusively known, but the industry must use every effort to characterize and control these conditions, applying a rapidly changing landscape of assays, instrumentation, formulation strategies and process steps. The PEGS Protein Aggregation and Stability in Biopharmaceutical Products offers important scientific updates and a forum for dialog among the stakeholders in this challenging arena.  Program

Protein Aggregation and Emerging Analytical Tools

Protein Aggregation and Emerging Analytical Tools January 23-24, 2020• San Diego, CA Program |  covers latest trends, challenges and solutions in understanding, characterization and mitigation of problems generated by protein aggregation in biopharmaceuticals. This conference will feature in-depth case studies, new and unpublished data and interactive discussions on immunogenicity of aggregates, mechanisms of aggregation, new tools for detection and quantitation of aggregates, and how the data is used in regulatory filings. It will also discuss mechanistic understanding of protein aggregation and present case studies on prevention of particle formation by engineering and formulation approaches, aggregation in ADCs, bipecifics, impact of aggregation on production, aggregates as a factor for immunogenicity, and approaches for improvement of biophysical properties of protein solutions.  Related term: immunogenicity

protein therapeutics: 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

therapeutic antibodies Emerging Indications for Therapeutic Antibodies R&D ADVANCES IN NON-CANCER INDICATIONS FOR ANTIBODIES AND OTHER BIOTHERAPEUTICS APRIL 8-9, 2019, Boston MA  Significant scientific advances in the fields of immunology and protein science are driving the development of biotherapeutic drugs in a growing range of therapeutic areas beyond oncology. These advances are driving the identification of new and unique targets, new approaches to developing biotherapeutics for unserved medical needs, methods of binding to illusive targets and translational science for patient stratification and drug development for niche indications.

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

yeast display (or yeast surface display) is a protein engineering technique that uses the expression of recombinant proteins incorporated into the cell wall of yeast for isolating and engineering antibodies. Wikipedia accessed 2018 Feb 12

Biologics resources
Biological Therapeutics Conferences  
Molecular Medicine Tri Conference
PepTalk The Protein Science Week
Protein Engineering Summit PEGS
PEGs Europe 

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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