Approvals of biologic drugs from EMA and FDA include new molecular entities (NMEs), expanded therapeutic indications, new dosage forms, novel formulations, and biosimilars. In the light of COVID-19, much of the biologic EUAs pertain to vaccines and anti-viral drugs against the SARS-CoV-2 virus. In addition, a number of breakthrough innovations have been approved for rare diseases, which is consistent with the current shift towards speciality drugs in the pharma industry.
News, Scientific Resources
Therapeutic antibodies against Omicron and new variants
The new variant of SARS CoV-2, B.1.1.529 Omicron, was designated as a variant of concern (VOC) by the World Health Organization (WHO). The virus's capacity to bind to ACE2 continues to be a key factor in its pathogenicity. Drugs for prophylactic therapy or preventing adverse effects are still under development. Even though Omicron is more transmissible than delta and resistant to most vaccinations and monoclonal antibodies, we still have at least two authorized monoclonal antibody treatments- Sotrovimab and Evusheld.
Biological Orphan Drugs: what defines them and regulatory requirements
Orphan drugs are designed to treat disease conditions that are rarely observed in people. In the US, FDA’s Office of Orphan Products Development (OOPD) and in the EU, EMA’s Committee for Orphan Medicinal Products (COMP) authorizes orphan drug designation (ODD) to medicines for rare or orphan diseases.
Therapeutic mAbs, Scientific Resources
Formats of Therapeutic Antibodies
The latest antibody engineering toolbox allows exploitation of the modular nature of antibodies to create a remarkable array of diverse and flexible formats of therapeutic antibodies. It is now possible to construct non-natural therapeutic antibodies with predetermined properties on a large scale.
Merry Christmas and a Happy New Year
News, Press Releases
Bispecific Antibody Therapies in Cancer Immunology – Evidentic Scholarship 2021
Evidentic has launched a scholarship program in order to promote research projects of young researchers. This year we have awarded Ashley Reid, a PhD student from the Icahn School of Medicine at Mount Sinai, New York, United States.
Therapeutic Antibodies for COVID-19
Anti-virus monoclonal antibodies are currently considered one of the most effective therapeutic strategies to reduce viral replication and prevent mortality. Interestingly, experiments in animal models also show that neutralizing mAb therapies can potentially mitigate onward viral transmission.
Biologics drug development pipeline Part 3: Lead generation and optimization
Once hits are generated by mAb clones using hybridoma technology, phage display or yeast display platforms, screening takes place. Following screening, lead selection involves a rigorous, multi-step filtering process to select a lead molecule(s) that matches the pre-established criteria or critical quality attributes (CQAs), for advancement into the next phase of drug development.
Early phase Biologics development Part 2: Target Research
Target research is initiated by target identification and selection leading to target validation before proceeding to the lead discovery phase, in which a drug-like small molecule or biological therapeutic is generated, screened and selected.
Early phase Biologics development Part 1: Overview of pipeline
The demand for biotherapeutic drugs is on the rise. Monoclonal antibody (mAb) drugs have shown remarkable success rates. Therefore, in the recent decade, the pharmaceutical industry shifted its focus to expand its therapy portfolio by including and developing therapeutic antibodies.
Development of anti-drug antibody (ADA) – based assays
Administration of Biotherapeutics into patients may provoke an immune response leading to the development of anti-drug antibodies (ADAs). ADAs affect the product's pharmacokinetic profile, pharmacodynamic effect, clinical efficacy or safety.
Cell therapy using Chimeric antigen receptors – CARs
CAR-T, CAR-NK and CAR-M cell therapies
Antibody drug conjugates (ADC) for therapy
Delivering chemotherapy with the specificity of monoclonal antibodies!
Endotoxin levels in Biologics!
Know your Biologic’s endotoxin levels!
Therapeutic mAbs, Analytics, News
Host Cell Protein analysis for biologics development
What are host cell proteins in biologic drugs?
News, Therapeutic mAbs
Critical Quality Attributes (CQAs) of Biologic Drugs
Defining critical quality attributes of biologics
Therapeutic mAbs, News, Scientific Resources
Therapeutic antibodies as Immune checkpoint inhibitors
Immunotherapy and Immune checkpoint inhibitors
Bispecific antibodies, Therapeutic mAbs
Bispecific Antibodies: Coming-of-age in Antibody Therapeutics (Part 2 of 2)
Bispecific Antibodies: Therapeutic applications and clinical pipeline. Bispecific antibodies have triggered considerable interest in the medical field and in the pharmaceutical industry over the last few years.
Excipients: The inactive ingredients of biologics!
What are excipients for biologics?
Therapeutic mAbs, Biosimilars
Therapeutic Antibodies to Treat Cancer Targeting CD20
Therapeutic antibodies for cancer targeting CD20 have been successfully used in immunotherapies to treat B-cell malignancies and auto-immune diseases.
Therapeutic mAbs, Biosimilars
Characterization of Therapeutic Monoclonal Antibodies
Characterization of therapeutic monoclonal antibodies are important to screen the right mAb molecule by defining the critical quality attributes.
Therapeutic mAbs, Biosimilars
Differences between Reference drugs (RMPs/RLDs) and Reference Standards
It is important to first establish a reference standard while assessing biosimilarity between a biosimilar product and the reference product.
Bispecific antibodies, News
Bispecific Antibodies: Coming-of-age in antibody therapeutics (Part 1 of 2)
Discovery of antibodies, also known as immunoglobulins, paved the way for the evolution of protein-based therapeutic molecules (biologics).
Reference Drugs for Biopharmaceuticals
Evidentic GmbH today announced the availability of reference drugs in aliquot format for the biopharma industry.
Monoclonal Antibody Therapy
Monoclonal antibody therapies have elevated precision medicine by enabling targeted therapy and providing personalized treatment options.
The Advent of Therapeutic Antibodies
Antibodies are important components of the immune system that confer specific immunity. The specific targeting ability of antibodies has been exploited in research and medical diagnosis since decades.
Biosimilar Development: Biocomparability Exercise
Monoclonal antibodies (mAbs) are an important class of biologics that have altered the treatment landscapes in several therapeutic areas such as cancer, auto-immune diseases, and viral infections.
Biosimilar comparability exercise
The biosimilar comparability exercise is a series of studies characterizing quality attributes of a reference and a biosimilar product. Approval of the biosimilar product by regulatory agencies is based on demonstrating high similarity between reference and biosimilar products. Guidelines for the conducting of biosimilar comparability exercises have been published by the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA).
Anti-IL-6R mABs for Rheumatoid Arthritis
Interleukins (IL) are a class of cytokines, which are signalling protein, peptide or glycoproteins molecules that are secreted by cells of the immune system. They act on different cell types to regulate the immune response, inflammatory responses, cell growth, cell migration, fibrosis, and angiogenesis.
Biologic Drugs for Rheumatoid Arthritis
The disease rheumatoid arthritis (RA) is a manifestation of a chronic inflammatory disorder. It is a common autoimmune disorder that affects approx. 0.5%–1% of the adult population. It is characterized by inflammation of synovium accompanied by articular bone and cartilage damage.
Certificate of Analysis (CoA)
A Certificate of Analysis (CoA) is an important document provided with a range of manufactured products like food, chemicals, research products, and pharmaceutical products.