Find here scientific publications regarding biological drug development breakthroughs as well as other important scientific resources.
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.
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.
Cell therapy using Chimeric antigen receptors – CARs
CAR-T, CAR-NK and CAR-M cell therapies
Endotoxin levels in Biologics!
Know your Biologic’s endotoxin levels!
Therapeutic mAbs, News, Scientific Resources
Therapeutic antibodies as Immune checkpoint inhibitors