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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
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3564302/
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-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. https://www.chi-peptalk.com/antibody-drug-conjugates-conference/ 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 http://www.sciencedirect.com/topics/medicine-and-dentistry/antibody-drug-conjugate 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 https://adcreview.com/adc-university/adcs-101/antibody-drug-conjugates-adcs/ 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. http://www.pegsummit.com/Antibody-Drug-Conjugates/ 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.
http://www.pegsummiteurope.com/antibody-drug-conjugates/
Clinical Progress of Antibody-Drug Conjugates
Advancing Novel ADC Platforms and Combinations to the Clinic 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
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
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.
http://www.pegsummiteurope.com/CART-TILs-TCR 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
https://www.thermofisher.com/tw/en/home/references/gibco-cell-culture-basics/introduction-to-cell-culture.html/ad24371c
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
https://en.wikipedia.org/wiki/Pharmaceutical_formulation
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
https://ghr.nlm.nih.gov/primer/therapy/genetherapy
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.
https://en.wikipedia.org/wiki/Immunogenicity 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.
http://www.pegsummit.com/Immunogenicity/
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.
http://www.pegsummit.com/Immunogenicity-Mitigation/
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.
http://www.insightpharmareports.com/Therapeutic-Monoclonal-Antibodies/
Oligonucleotide &
Precision Therapeutics
March
26-28, 2019 Cambridge, MA
Program advances
in next-generation oligonucleotide therapies throughout the drug
development process.
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 2019
Nov Lisbon Portugal Conference
programs include Engineering, Oncology, Analytical, Immunotherapy, Expression and
Bispecifics.
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.
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
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
Biologics resources
IUPAC definitions are reprinted with the permission of the International Union of Pure and Applied Chemistry. |
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