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What is Biologics

Nov 12 , 2024

Biologics, or biological drugs, are complex medications derived from living cells rather than synthesized from chemicals. They are used to treat various medical conditions, including autoimmune diseases, cancers, and infectious diseases. Because biologics are composed of large, complex molecules or mixtures of molecules (like proteins, nucleic acids, or living cells), they require special handling and storage.

Requirements for COP vials for cell-based drugs

RTU(ready to use) 2ml COP vial

Key Aspects of Biologics

Complex Structure: Biologics are typically large, complex proteins or other macromolecules. This complexity makes them highly sensitive to environmental factors like temperature, pH, and exposure to light.


Production from Living Cells: Biologics are produced using living organisms or cells, often through recombinant DNA technology. This process can involve bacteria, yeast, or mammalian cells, which makes production more complex and sensitive compared to traditional drugs.


Targeted Therapy: Unlike traditional drugs, which may have a broad effect, biologics are often designed to target specific molecules or cells within the body, leading to highly specific treatments. This specificity can result in fewer side effects and improved efficacy for certain conditions.


Common Types of Biologics

Monoclonal Antibodies (mAbs): These are engineered antibodies designed to bind to specific targets, like cancer cells or proteins involved in autoimmune diseases. Examples include treatments like adalimumab (Humira) and pembrolizumab (Keytruda).


Vaccines: Biologics also include vaccines, which use parts of pathogens (like proteins or mRNA) to stimulate an immune response and confer immunity against diseases.


Cell Therapies: This includes treatments like CAR-T cell therapy, where a patient’s own cells are modified to target and destroy cancer cells.


Gene Therapies: Gene therapies introduce, remove, or modify genetic material to treat diseases, often those caused by genetic mutations.


Biosimilars: These are highly similar to an already FDA-approved biologic (known as the reference product). They offer a more cost-effective alternative to some biologics while maintaining similar safety and efficacy.


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