biopharmaceutical , also known as biological medical product (al) , biological , or biological , is any product of the drug drugs produced, extracted from, or semisynthesized from biological sources. Different from thoroughly synthesized drugs, they include vaccines, blood, blood components, allergenic, somatic cells, gene therapy, tissue, recombinant therapeutic proteins, and living cells used in cell therapy. Biologists may consist of sugars, proteins, or nucleic acids or complex combinations of these substances, or perhaps living cells or tissues. They (or their precursors or components) are isolated from living sources - humans, animals, plants, fungi, or microbes.
The terminology surrounding biopharmaceuticals varies between groups and entities, with different terms referring to different subsets of therapy in the general biopharmaceutical category. Some regulatory bodies use the term "biological drug product" or "therapeutic biological product" to refer specifically to engineered macromolecule products such as proteins and nucleic acid-based drugs, which distinguish them from products such as blood. , a blood component, or a vaccine, which is usually taken directly from a biological source. Specific drugs, the latest classification of drugs, are high-cost drugs that are often biological. The European Medicines Agency uses the term 'advanced drug therapy products' (ATMPs) for pharmaceuticals for human use based on genes, cells or tissue engineering, including gene therapy drugs, somatic cell therapy drugs. , tissue-engineered drugs, and their combinations. In the context of EMA, the term advanced therapy refers specifically to ATMPs, although the term is somewhat non-specific outside the context.
Gene-based and cellular biology, for example, are often at the forefront of biomedical research, and can be used to treat various medical conditions for which no other treatments are available.
In some jurisdictions, biologics are regulated through different pathways from small molecular drugs and other medical devices.
The term biopharmacology is sometimes used to describe pharmacological branches that study biopharmaceuticals.
Video Biopharmaceutical
Primary class
Extracted from live system
Some of the oldest biological forms are extracted from animal bodies, and other humans in particular. Important biology includes:
- Whole blood and other blood components
- Organ and network transplants
- Stem cell therapy
- Antibodies for passive immunization (eg, to treat viral infections)
- human milk
- Stage microbiota
- Human reproduction cells
Some biologists previously extracted from animals, such as insulin, are now more commonly produced by recombinant DNA.
Produced by recombinant DNA
As indicated the term "biological" can be used to refer to a wide range of biological products in medicine. However, in many cases, the term "biological" is used more limited to therapeutic classes (approved or in development) generated through biological processes involving recombinant DNA technology. These drugs are usually one of three types:
- Substance that (almost) is identical with the body's own key signaling protein. An example is a protein erythropoetin that stimulates blood production, or growth-stimulating hormone called (simple) "growth hormone" or human biosynthetic and analogous insulin.
- Monoclonal antibodies. This is similar to the antibodies used by the human immune system to fight bacteria and viruses, but they are "specially designed" (using hybridoma technology or other methods) and can therefore be made specifically to counteract or block substances administered in the body, or to target specific cell types; examples of monoclonal antibodies for use in various diseases are given in the table below.
- Receptor construction (fusion protein), usually based on natural receptors associated with the immunoglobulin skeleton. In this case, the receptor provides constructs with detailed specificity, while the immunoglobulin structure imparts stability and other useful features in pharmacology. Some examples are listed in the table below.
Biology as a class of drugs in this narrow sense has a profound impact on many medical fields, especially rheumatology and oncology, but also cardiology, dermatology, gastroenterology, neurology, and others. In most of these disciplines, biology has added major therapeutic options for the treatment of many diseases, including some that no effective therapy is available, and others where previously existing therapies are clearly inadequate. However, the advent of biological therapy has also led to complex regulatory issues (see below), and significant pharmacoeconomic concerns, as the costs for biological therapy have been much higher than conventional (pharmacological) drugs. This factor is particularly relevant because many biologics are used for the treatment of chronic diseases, such as rheumatoid arthritis or inflammatory bowel disease, or for treatment of cancer that can not be treated for the rest of life. The cost of treatment with typical monoclonal antibody therapy for relatively common indications is generally in the range of EUR7,000-14,000 per patient per year.
Older patients who receive biological therapy for diseases such as rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis are at increased risk for life-threatening infections, adverse cardiovascular events, and malignancies.
The first such substance approved for therapeutic use is the biosynthetic "human" insulin made through recombinant DNA. Sometimes referred to as rHI, under the tradename Humulin, developed by Genentech, but licensed to Eli Lilly and Company, which produced and marketed it in 1982.
The main types of biopharmaceuticals include:
- Blood Factor (Factor VIII and Factor IX)
- Thrombolytic agents (plasminogen tissue activators)
- Hormones (insulin, glucagon, growth hormone, gonadotropin)
- Hematopoietic growth factor (Erythropoietin, colony stimulating factor)
- Interferon (Interferon-?, -?, -?)
- Interleukin-based products (Interleukin-2)
- Vaccines (hepatitis B surface antigen)
- Monoclonal antibodies (Diverse)
- Additional products (tumor necrosis factor, therapeutic enzyme)
The research and development of investment in new medicines by the biopharmaceutical industry reached $ 65.2 billion in 2008. Some of the biological examples made with recombinant DNA technology include:
Vaccines
Many vaccines grow in tissue culture.
Gene therapy
Viral gene therapy involves artificial manipulation of the virus to include the desired part of the genetic material.
Maps Biopharmaceutical
Biosimilars
With the end of various patents for blockbuster biology between 2012 and 2019, interest in biosimilar production, that is, subsequent biological, has increased. Compared to small molecules composed of chemically identical active ingredients, biology is much more complex and consists of many subspecies. Because of their heterogeneity and high process sensitivity, precursors and advanced biosimilars will exhibit variability in certain variants over time, but the safety and clinical performance of both originator and biosimilar biopharmaceuticals must remain the same throughout their life cycle. Process variation is monitored by modern analytical tools (eg, liquid chromatography, immunoassays, mass spectrometry, etc.) and describes a unique design space for every biological.
Thus, biosimilars require different regulatory frameworks compared to small molecule generic drugs. The legislation of the 21st century has addressed this by acknowledging the intermediate testing ground for biosimilars. Archiving paths require more testing than small generic molecular drugs, but fewer tests than registering completely new therapies.
In 2003, the European Medicines Agency introduced an adaptation pathway for biosimilars, called a similar biological drug product. The line is based on a "comparative" overall demonstration of a "similar" product for an approved product. In the United States, Patient Protection and the Affordable Care Act of 2010 create an abbreviated approval line for biological products that are biochemically proven, or interchangeable with, FDA licensed biological reference products. The main expectations associated with the introduction of biosimilars are cost reduction for patients and health care systems.
Commercialization
When a new biopharmaceutical is developed, the company will usually apply for a patent, which is a grant for exclusive manufacturing rights. This is the primary means by which drug developers can recover investment costs for biopharmaceutical development. The patent laws in the United States and Europe differ somewhat on the requirements for patents, with European requirements considered more difficult to fulfill. The total number of patents granted for biopharmaceuticals has increased significantly since the 1970s. In 1978, the total patent granted was 30. This has increased to 15,600 in 1995, and in 2001 there were 34,527 patent applications. In 2012 the US has the highest IP (Intellectual Property) generation in the biopharmaceutical industry, generating 37 percent of the total number of patents awarded worldwide, however, there is still considerable margins for growth and innovation in the industry. Revisions to current IP systems to ensure greater reliability for R & D D (research and development) investment is a prominent topic of debate in the US as well. Other human derived blood and biological products such as breast milk have high regulation or are very difficult to access the market, therefore, customers generally face a shortage of supply for these products because of their nature and often these biological, banks', can not distribute their products to customers effectively. In contrast, banks for Reproductive cells are much more extensive and available because of the ease of spermatozoa and eggs that can be used for fertility treatments.
Large scale production
Biopharmaceuticals may be produced from microbial cells (eg, recombinant E. coli or yeast cultures), mammalian cell lines (see cell culture) and plant cell cultures (see plant tissue culture) and moss plants in various configuration bioreactors , including photo-bioreactors. Important issues of concern are production costs (low-volume products, high purity desired) and microbial contamination (by bacteria, viruses, mycoplasma). The alternative production platforms being tested include all plants (pharmaceutical artificial plants).
GMO
The potentially controversial method of producing biopharmaceuticals involves transgenic organisms, especially plants and animals that have been genetically modified to produce drugs. This production is a significant risk to investors, due to production failure or oversight of regulatory bodies based on perceived risks and ethical issues. Biopharmaceutical plants also represent the risk of cross contamination with non-engineered plants, or plants that are engineered for non-medical purposes.
One potential approach to this technology is the creation of transgenic mammals that can produce biopharmaceuticals in milk, blood, or urine. Once the animals are produced, usually using the pronuclear microinjection method, it becomes efficacious to use cloning technology to create additional offspring that carry advantageous gene modifications. The first drug made from genetically modified goat milk was ATryn, but its marketing permission was blocked by the European Medicines Agency in February 2006. This decision was canceled in June 2006 and approval was granted in August 2006.
Rule
European Union
In the European Union, biological medicinal products are either an active substance produced from or extracted from a biological (live) system, and require, in addition to physicochemical testing, biological testing. for full characterization. The characterization of biological drug products is a combination of testing of the active substance and the final drug product together with the production process and its control. As an example:
- The production process - can come from biotechnology or from other technologies. These can be prepared using more conventional techniques as well as for blood or plasma derivative products and a number of vaccines.
- Active substance - consists of all microorganisms, mammalian cells, nucleic acids, proteins, or polysaccharide components derived from microbial, animal, human or plant sources.
- Mode of action - therapeutic and immunological drug products, gene transfer material, or cell therapy materials.
United States
In the United States, biologics are licensed through a biology licensing application (BLA), then submitted and regulated by the FDA's Center for Evaluation and Biological Research (CBER) while medicines are regulated by the Center for Drug Research and Research. Approval may take 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 manufacturing process must comply with the FDA's "Good Manufacturing Practice", which is usually produced in a clean room environment with strict limits on the amount of airborne particles and other microbial contaminants that can alter the effectiveness of the drug.
See also
- Antibody-drug conjugate
- Genetic engineering
- List of recombinant proteins
- List of pharmaceutical companies
- Nanobiopharmaceutics
References
External links
- Biological Products at the National Library of Medicine US Medical Subject Title (MeSH)
- Debbie Strickland (2007). "Guide to Biotechnology" (PDF) . Organization of Biotech Industry (BIO) . Retrieved 2007-12-17 .
- Timothy B. Coan; Ron Ellis (2001-06-01). "Report for Specialty Pharmaceuticals: Generic Biologics: The Next Frontier" (PDF) . Consumer Project on Technology . Retrieved 2007-12-17 .
- "About biologics". National Psoriasis Foundation. 2006-11-01 . Retrieved 2007-12-17 .
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