The future of 'bioprocessing' for medical therapies

What's in store for the future of industrial bioprocessing for medical therapies, which involves the use of living organisms or cells to create drugs or other agents? Will the batch or continuous bioprocessing platform dominate ...

The dual significance of bacterial protein secretion

Secretion of bacterial proteins is an essential biological process with biotechnological and biomedical impact on human health. European scientists studied a universal and widely conserved bacterial secretory pathway towards ...

Samsung outlines $20.6 billion investment plan

(AP) -- Samsung said Tuesday it plans to invest 23.3 trillion won ($20.6 billion) over the next decade in technologies including solar cells and medical devices, aiming to boost sales and increase its work force by tens ...

Slackers and superstars of the microbial workplace

Drug companies often use yeast to manufacture drugs, especially proteins such as antibodies and enzymes. It has been assumed that a batch of genetically identical yeast will secrete such drugs at uniform rates, but MIT chemical ...


Biopharmaceuticals are medical drugs (see pharmacology) produced using biotechnology. They include proteins (including antibodies), nucleic acids (DNA, RNA or antisense oligonucleotides) and living microorganisms like virus and bacteria where the virulence of viruses and bacteria is reduced by the process of attenuation, they can be used for therapeutic or in vivo diagnostic purposes, and are produced by means other than direct extraction from a native (non-engineered) biological source.

The first such substance approved for therapeutic use was biosynthetic 'human' insulin made via recombinant DNA technology. Sometimes referred to as rHI, under the trade name Humulin, was developed by Genentech, but licensed to Eli Lilly and Company, who manufactured and marketed the product starting in 1982.

The large majority of biopharmaceutical products are pharmaceuticals that are derived from life forms. Small molecule drugs are not typically regarded as biopharmaceutical in nature by the industry. However members of the press and the business and financial community often extend the definition to include pharmaceuticals not created through biotechnology. That is, the term has become an oft-used buzzword for a variety of different companies producing new, apparently high-tech pharmaceutical products. Research and development investment in new medicines by the biopharmaceutical industry stood at $65.2bn in 2008.

When a biopharmaceutical is developed, the company will typically apply for a patent, which is a grant for exclusive manufacturing rights. This is the primary means by which the developer of the drug can recover the investment cost for development of the biopharmaceutical. The patent laws in the United States and Europe differ somewhat on the requirements for a patent, with the European requirements are perceived as more difficult to satisfy. The total number of patents granted for biopharmaceuticals has risen significantly since the 1970s. In 1978 the total patents granted was 30. This had climbed to 15,600 in 1995, and by 2001 there were 34,527 patent applications.

Within the United States, the Food and Drug Administration (FDA) exerts strict control over the commercial distribution of a pharmaceutical product, including biopharmaceuticals. Approval can require several years of clinical trials, including trials with human volunteers. Even after the drug is released, it will still be monitored for performance and safety risks.

The manufacture of the drug must satisfy the "current Good Manufacturing Practices" regulations of the FDA. They are typically manufactured in a clean room environment with set standards for the amount of airborne particles.

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