Biopharmaceutics is the field of study concerning biopharmaceuticals, 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. Biologics are technically a subset of biopharmaceuticals, though the latter term is more likely to be used to refer to macromolecular products like protein-based and nucleic-acid-based drugs, while the term biologic is used more often when the medical product is composed of cellular or tissue based products (e.g. stored packed Red Blood Cell units).
History
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.
Description
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 often-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.
Commercialization
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.
Regulation
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.
Major kinds of biopharmaceuticals
• Blood factors (Factor VIII and Factor IX)
• Thrombolytic agents (tissue plasminogen activator)
• Hormones (insulin, glucagon, growth hormone, gonadotrophins)
• Haematopoietic growth factors (Erythropoietin, colony stimulating factors)
• Interferons (Interferons-α, -β, -γ)
• Interleukin-based products (Interleukin-2)
• Vaccines (Hepatitis B surface antigen)
• Monoclonal antibodies (Various)
• Additional products (tumour necrosis factor, therapeutic enzymes)
Uses
• Erythropoietin - Treatment of anaemia
• Interferon-α - Treatment of leukaemia
• Interferon-β - Treatment of multiple sclerosis
• Monoclonal antibody - Treatment of rheumatoid arthritis
• Colony stimulating factors - Treatment of neutropenia
• Glucocerebrosidase - Treatment of Gaucher's disease
Click here to browse books on Biopharmaceutics and Pharmacokinetics
History
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.
Description
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 often-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.
Commercialization
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.
Regulation
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.
Major kinds of biopharmaceuticals
• Blood factors (Factor VIII and Factor IX)
• Thrombolytic agents (tissue plasminogen activator)
• Hormones (insulin, glucagon, growth hormone, gonadotrophins)
• Haematopoietic growth factors (Erythropoietin, colony stimulating factors)
• Interferons (Interferons-α, -β, -γ)
• Interleukin-based products (Interleukin-2)
• Vaccines (Hepatitis B surface antigen)
• Monoclonal antibodies (Various)
• Additional products (tumour necrosis factor, therapeutic enzymes)
Uses
• Erythropoietin - Treatment of anaemia
• Interferon-α - Treatment of leukaemia
• Interferon-β - Treatment of multiple sclerosis
• Monoclonal antibody - Treatment of rheumatoid arthritis
• Colony stimulating factors - Treatment of neutropenia
• Glucocerebrosidase - Treatment of Gaucher's disease
Click here to browse books on Biopharmaceutics and Pharmacokinetics