Common differences between biopharmaceutical manufacturing and traditional manufacturing

Engineering in the pharmaceutical areas have opened new horizons of drug development and it has altered the traditional manufacturing process. Biopharmaceuticals are overpowering the pharmaceutical industry due to their efficiency, reliability, and benefits. Down below are the major differences explained between a biopharmaceutical manufacturing and traditional manufacturing.

  1. Biopharmaceuticals are the drugs made by biotechnology process. These are proteins, nucleic acids, DNA, and RNA made for in-vivo diagnostic and therapeutic purposes. It can be made from living forms generally a plant or an animal. Traditional manufacturing is the drugs that are made from chemical synthesis by combining specific chemical ingredients.
  2. Drugs manufactured by the traditional process have a well-defined chemical structure. They can be broken up for analysis of the various components. On the other hand, detailed analysis of biopharmaceuticals is not possible as it is a finished biologic. As biological forms can’t be broken up and some of the components of biologics are still unknown.
  3. The manufacturing process of a biopharmaceutical company can’t be altered thereafter. For biopharmaceuticals, the product is the process as they can’t be characterised in the laboratory. The manufacturer must sustain the product quality and purity to ensure the manufacturing process remains same over time. Contrary, for the traditional manufacturers the traditional medicine process can be modified and altered whenever required. It is possible for traditional drugs as their chemical composition is known. Thus, a manufacturer upon his requirement can opt for the same manufacturing process or an altered manufacturing process.
  4. The cost of biopharmaceuticals medicines is higher than the cost traditional medicines. Additionally, the traditional drugs are available almost everywhere without a medical prescription. Whereas, the biopharmaceuticals are generally not available everywhere. Biopharmaceutical products pose a low reimbursement level from the medical insurance companies.
  5. The traditional manufacturing companies make traditional medicines that cure disease and protect from other infections or illness. Additionally, they produce supplements, health products etc. to treat human health issues. On the other hand, biopharmaceuticals make drugs that alter the functioning of the living cell so as to control the disease. Many biopharmaceutical products are meant for diagnostics as well. The focus of biopharmaceutical is to treat the untreatable diseases like cancer and HIV.
  6. The traditional manufacturers conduct extensive research, licensing, and marketing of their products. The research is done different forms of chemicals and their synthesis. But, in the biopharmaceuticals genetic engineering, recombinant DNA technology, cellular processing etc. are the engineering processes. They work mainly on DNA, nucleic acids, and proteins.
  7. Medicines made by traditional manufacturing process can be copied exactly by the second manufacturer once they become generic. But, for the biopharmaceutical products making the exact copy of the product is impossible. There are specific process controls for biopharmaceuticals. Each manufacturing process has a separate process control that is unique and confidential. Therefore, it’s impossible for the second manufacturer to make the same replica of the product as they don’t have the same biological knowledge and experience like the original manufacturer.


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