Evidentic Blog

Clinical grade vs research grade molecules

Scientific Resources

How to identify the right molecule for your assay

Why you should distinguish clinical-grade from research-grade molecules

Aproved biologics from 2017 to 2021

News

Biologic drugs approvals in 2021

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.

Omicron Therapeutic antibodies

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.

Evidentic aliquots

Scientific Resources

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 antibodies formats

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.

News

Merry Christmas and a Happy New Year

The different immune mechanisms which are engaged to kill tumor cells by using bispecific antibodies as a tumor therapy

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.

Neutralizing mAbs

News

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.

Lead optimization

Scientific Resources

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.

Target id and description

Scientific Resources

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.

biologics pipeline development

Scientific Resources

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.

Types of Anti-idiotype antibodies

Analytics

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.

Structure of Chimeric Antigen Receptors (CARs)

Scientific Resources

Cell therapy using Chimeric antigen receptors – CARs

CAR-T, CAR-NK and CAR-M cell therapies

Therapeutic mAbs

Antibody drug conjugates (ADC) for therapy

Delivering chemotherapy with the specificity of monoclonal antibodies!

Scientific Resources

Endotoxin levels in Biologics!

Know your Biologic’s endotoxin levels!

HCP analysis for biologics development

Therapeutic mAbs, Analytics, News

Host Cell Protein analysis for biologics development

What are host cell proteins in biologic drugs?

QbD for biologics development

News, Therapeutic mAbs

Critical Quality Attributes (CQAs) of Biologic Drugs

Defining critical quality attributes of biologics

Therapeutic antibodies as Immune checkpoint inhibitors

Therapeutic mAbs, News, Scientific Resources

Therapeutic antibodies as Immune checkpoint inhibitors

Immunotherapy and Immune checkpoint inhibitors

Bispecific Antibodies

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.

Novel excipient

News

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.

Antibody

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).

News

Reference Drugs for Biopharmaceuticals

Evidentic GmbH today announced the availability of reference drugs in aliquot format for the biopharma industry.

Therapeutic mAbs

Monoclonal Antibody Therapy

Monoclonal antibody therapies have elevated precision medicine by enabling targeted therapy and providing personalized treatment options.

Antibodies classification

Therapeutic mAbs

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.

Comparability Exercise during Biosimilar Development

Biosimilars

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.

Biosimilars

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).

Therapeutic mAbs

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.

Therapeutic mAbs

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.

Biosimilars

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.

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