What are Biopharmaceuticals?
Biopharmaceuticals, also known as biologics or biosimilars, are medicines made from living cells or organisms. They differ from small molecule medicines, which are made from chemicals through chemical synthesis. They are complex molecules engineered from biological sources using biotechnology. They include hormones, cytokines, growth factors, monoclonal antibodies, and therapeutic enzymes.
How are They Made?
Biopharmaceuticals production of it starts with cultivating living cells or organisms in large steel or stainless-steel vessels called bioreactors that can hold thousands to millions of litres of growth material. Living cells such as bacteria, yeast, or mammalian cells are cultured in bioreactors containing nutrients to support and encourage cell growth. As cells multiply in the bioreactors, they express and secrete the therapeutic protein into the surrounding liquid medium.
The cells and growth medium are then separated through various separation techniques like filtration or centrifugation. The therapeutic protein is extracted from the medium and undergoes multiple purification processes like chromatography to remove contaminants resulting in purified drug substance. Downstream processing is critical to remove any unwanted components from the biomanufacturing process. The purified drug substance then undergoes rigorous quality control testing for identity, purity, and potency. Once approved, it is formulated, filled into vials or prefilled syringes, and packaged for shipping and storage under proper temperature-controlled conditions.
Types
There are different classes of it based on their source and structure:
- Monoclonal antibodies are proteins made by identical immune cells that are clones of a unique parent cell. They recognize and lock onto antigens or foreign substances like cancer cells or bacteria. Examples include bevacizumab, rituximab, trastuzumab.
- Hormones are molecules produced by glands in the body to regulate physiological processes. Recombinant versions are made through biotechnology like human growth hormone, insulin, follicle-stimulating hormone.
- Cytokines are signaling molecules produced by immune cells that stimulate or inhibit the activity of other immune cells. Interferons and granulocyte colony-stimulating factor are cytokine biopharmaceuticals.
- Coagulation factors are proteins involved in blood clotting. Examples are antihemophilic factors for treating hemophilia.
- Enzymes are protein catalysts that speed up biochemical reactions. Biologics include enzymes like pancrelipase for treating pancreatic insufficiency.
Benefits
Biopharmaceuticals have several advantages over small molecule drugs:
- Targeted action: Due to their large size and complexity, biologics can precisely target tissues, pathways or cell receptors linked to specific diseases with fewer side effects than traditional drugs.
- Tailored protein therapies: They produced in living cells through genetic engineering allow development of therapies tailored to human proteins and their modes of action in the body.
- Treatment of previously untreatable diseases: Biologics have made it possible to treat complex diseases like cancer, Chronic inflammatory diseases, HIV/AIDS which were not possible to target using conventional drugs.
- Personalized medicine: Insulin, growth factors, monoclonal antibodies are revolutionizing the field of personalized and precision medicine by considering individual patient parameters.
- High specificity and lower toxicity: Biopharmaceuticals have fewer off-target effects and lower risk of toxicities compared to small molecule drugs due to their superior selectivity for disease targets.
Challenges of Development and Manufacturing
While they offer several therapeutic advantages, their development and manufacturing also present unique complex challenges:
- Molecular complexity: Multicomponent structures, three dimensional shapes, propensity for aggregation demands specialized manufacturing approaches.
- Challenges in scale-up and production: Production cost is high due to expensive large bioreactors, media, control of cell growth conditions and extensive purification needed.
- Product variability: Even minor changes in manufacturing process can impact product quality attributes requiring strict process analytical control.
- Short shelf life: Require temperature controlled transportation and storage due to instability issues compared to conventional drugs.
- Immunogenicity potential: Patient’s own immune system may generate anti-drug antibodies against biologics limiting their efficacy on repeated administration.
- Biosimilar development: Demonstrating biosimilarity and interchangeability with reference products for regulatory approval is more difficult than generic counterparts of small molecule drugs.
Future Prospects
The future looks promising for biopharmaceuticals due to growing unmet medical needs, better understanding of human biology and advances in biologics engineering:
- New biologic modalities like antibody drug conjugates, bispecific antibodies, engineered cell therapies are expanding the biologics pipeline.
- Development of sustainable and affordable manufacturing technologies like continuous bioprocessing will help increase production volumes for biologics.
- Combination products incorporating biologics with devices or conventional drugs hold potential to transform disease management.
- Utilization of ‘omics’ technologies, artificial intelligence, machine learning for accelerated bioprocess development and characterization.
- Improved formulations and drug delivery systems will augment biologics stability, uptake in tissues and enable self-administration of biologic drugs.
In the biopharmaceuticals have revolutionized treatment paradigms, improved patients’ lives and hold promise to accelerate development of advanced biological therapies over the next decade thanks to major technology advancements. Though production challenges exist, strategic manufacturing solutions will strengthen global access to these life-saving medicines.
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Vaagisha brings over three years of expertise as a content editor in the market research domain. Originally a creative writer, she discovered her passion for editing, combining her flair for writing with a meticulous eye for detail. Her ability to craft and refine compelling content makes her an invaluable asset in delivering polished and engaging write-ups.
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