BIOPHARMACEUTICAL & NANOTECHNOLOGY

BIOPHARMACEUTICAL & NANOTECHNOLOGY

In today’s technological age, it seems advancements in all fields leap forward by the day. Medical technology certainly hasn’t been left out of the loop, and some of the breakthroughs in modern medicine have been quite revolutionary and had a huge impact. But where will the field of medicine be in 20 years from now? What major advancements are waiting just around the next corner? In this article we will consider just two of the biggest technologies that are emerging over the horizon.

Electronic Implants

We have computers everywhere these days, but it’s not just the ones on our desks that we use to surf the net. We have computer chips in washing machines and just about all of our other appliances too. In the realm of science fiction (all too often a prediction of future science) we have seen technologically enhanced humans with superhuman abilities but what if those technologies were real and used for medical purposes?
Scientists have been working for years on implementing a special kind of microchip known as a “neuroprosthetic chip” that can be implanted into the brain. This chip helps to decipher signals in the brain when the brain itself cannot, and to trigger the appropriate responses. For example, the chip could help to control epileptic seizures, or help a patient suffering with paralysis to control prosthetic limbs with thought alone.

Stem Cell Research

One of the most talked about areas of medical technology today is stem cell research. With the first human trials currently taking place to determine the safety of human treatment, stem cell technology may not be too far away. The basis of stem cell therapy is regenerative: stem cells help the body to form new cells and generate tissue. If we can harness the power of stem cells for medical use, we may be able to cure paralysis, blindness, heart disease and diabetes, treat stroke patients and repair damaged organs and tissues, helping the body to regenerate and cure itself. Some people are even optimistic that stem cell research could lead to curing cancer!
Stem cell research has been the subject of much controversy. The needed stem cells are actually taken from embryos developed using IVF techniques as there are often surplus embryos and these are donated for scientific use. The stem cells gathered in this way are generic and have no predetermined cell type, which enables scientists to force the stem cells to become a specific, needed type of cell that can be injected into a patient in need of them. The embryos are only a few days old and about the size of a full stop (period), but there are many who think that stem cell research is just plain wrong; that it is “playing God” with an unborn child. This may all change as new research shed light on the ability to use adult stem cells, but only time will tell.

Nanomedicine

Nanotechnology, especially nanomedicine, are advancing significantly day by day. Nanoparticles are being already used in many products (mainly in cosmetics), but other spheres such as pharmaceutics and general medicine are slowly applying nanotechnology standards.
Nanomedicine, along with stem cells research, will probably change the way the world sees medicine. Many experts predict that it will change everything.

This was just a brief look at what the future of medicine may hold for us, but with these and many more exciting technologies rapidly emerging that future certainly looks bright.

BIOPHARMACEUTICAL
A biopharmaceutical is defined as a medical drug (proteins including antibodies, nucleic acids, DNA, RNA or antisense oligonucleotides) which is produced using biotechnology. In the late 1990s advances in manufacturing and processing revolutionized the production of biopharmaceuticals such as recombinant DNA technology and hybridoma technology. These technological advances have enabled the market place to open up and for smaller players to enter and capitalize on the growing need for targeted, personalized medicine.

During the 1960s and 1970s formulation began to assume greater importance. More recently still, the inconvenience of parenteral administration became a focus for attempts to minimize the burden and optimize treatment. Nowadays, any development programme for a new drug will include consideration of the optimal dosage form from the conception of a drug development project. A plethora of delivery platforms have evolved to meet market demands and overcome solubility and pharmacokinetic issues, and will have an important role to play in determining the dosage form that ultimately appears on the market.

The biopharm field represents a major opportunity for generic manufacturers with sufficient resources to withstand the relatively high development costs and the technological demand. It is estimated that biosimilars, targeting the six leading biopharm products, could generate revenues in excess of $2 billion within 2-3 years. However, there are considerable challenges facing companies developing and marketing biopharm products.

Manufacturing problems will remain a significant hurdle for companies entering this field; the regulation of innovator biopharm products continues to evolve and the harmonization of regulatory processes among the three main national regulatory agencies (the EU, the US and Japan) should make life simpler for biopharm companies seeking to establish a global presence for their products.

Biotherapeutics represent 7.5 percent of all drugs on the market; they account for approximately 10 percent of the total expenditure for marketed drugs and their use is growing at more than 20 percent per year. Biotechnology drug candidates account for around 32 percent of all pipeline research programs. In addition, biological drugs are administered in life-saving or end-stage applications, 74 percent more than chemically derived pharmaceuticals.

NANOTECHNOLOGY
Nanotechnology is the science of maneuvering and modifying the structure and properties of matter at an atomic and molecular scale. Due to these manipulations, inert elements start to function as catalyst, and insoluble matter develop unique solubility capacity. Likewise, non-colloids begin exhibiting excellent colloidal properties and electrical non-conductors start conducting electricity. All these materials can be used for a vast variety of purposes in field as diverse as medicine, energy production and electronics.

In recent years, nanotechnology has found innumerable applications in the field of medicine — from drug delivery systems, nano-robots and cell repair machines to imaging, nano-particles and nano-nephrology. Owing to the extensive use of nano-materials in medical equipments and devices, nano-medicine has become a significant branch of nanotechnology. Here are some important uses of nanotechnology in the field of medicine. All these things prove that nanotechnology will play a significant role in the future, and shows why nanotechnology is useful.

Drug Delivery System And Nanoparticles
The primary objective of the drug delivery system is to make the life-saving drug available in that part of the body where it is required the most. However, most of the time, these systems fail to work efficiently because the particles of the drug are too large for the cells to absorb, or they are insoluble or they have the potential to cause tissue damage. On the other hand, due to their exceedingly small size, nanoparticles are easily taken up by the cell. Moreover, they are completely soluble and they do not also damage the tissues. In nutshell, the efficiency of the drug delivery system can be increased several times by integrating nanoparticles with them.

Coupling Of Nanoparticles With Biopharmaceuticals
Biopharmaceuticals are peptides or protein molecules that trigger multiple reactions in the human body. They are widely used in the treatment of life-threatening diseases like cancer. The effectiveness of biopharmaceuticals can be increased several times by coupling them with nanoparticles, which will proficiently deliver the peptides or proteins at the tumor site and in this manner cure cancer without causing extensive damage to the adjacent tissues and organs.

Nanotechnology And Neuro-Electronic Devices
Neuro-electronic devices are unique machines based on nanotechnology that connect the nervous system with the computer. These devices not just detect and interpret the signals from the nervous system, but also control and respond to them. They can be used in the treatment of diseases that slowly and steadily decay the nervous system like multiple sclerosis.

Nanonephrology
This is a sub-branch of nanomedicine which is concerned with the detection and treatment of kidney diseases. Here various devices based on nanotechnology are used for the studying the different kidney processes and detecting disorders. Thereafter, nanoparticles and drug delivery system are used for curing the disorder.

Nanotechnology And Cell Repair Machines
These cell repair machines use nanotechnology to penetrate into the cell and rectify disorders like DNA damage or enzyme deficiency. These machines are no bigger than a bacteria or virus.

Nanorobots
The entry of nanorobots will literally revolutionize the world of medicine. These miniature devices would not only be capable of entering into the body and detecting the diseases and infection, but they will also be capable of repairing internal injuries and wounds.

Nanotech and Cancer
Nanotechnology deals with manipulating the structure as well as properties of matter at the atomic and molecular level. As the result of this maneuvering, the properties of matter change dramatically. While some insoluble elements develop high solubility capacity, inert substances start exhibiting catalyst properties. Owning to their size and properties, nanomaterials are extensively used for the treatment of a number of diseases. Cancer is such a disease where nanotechnology can play a significant role.

Nanoparticles And Nanorobots
Cancer is a condition where changes occur in a small percentage of cells and they start replicating interminably. Problems come to the fore only when the condition becomes unmanageable. The size of nanoparticles and nanorobots is exceedingly small, and because of this property, they can easily enter into the blood vessels, organs, tissues and even the cells of the body. Additionally, they can also find out those cells that are growing abnormally. Thus, they can play a decisive role in the detection of cancer at a very early stage.

Accurate Drug Delivery
Once the cancer has been detected, it becomes essential to treat it as quickly as possible. Most of the cancer treatment methods cause widespread damage because while eliminating the cancerous cells they also start acting upon the normal cells. Drug delivery systems that use nanoparticles can effectively treat cancer without damaging the surrounding cells and tissues. These nanoparticles are smaller than the body cells, and can easily carry the drug to that part of the body where the cancerous cells are located.

Biopharmaceuticals And Cancer
Biopharmaceuticals are basically proteins molecules that trigger multiple reactions in the human body. They are widely used in the treatment of cancer. The effectiveness of these pharmaceuticals will increase several times if they are coupled with nanoparticles. The nanoparticles will carry the biopharmaceuticals directly to the tumor site without adversely affecting the cells and tissues that come in the way. In this manner, cancer would be cured and healthy cells will remain as such.

Cell Repair Machine And Cancer Treatment
Cancer primarily occurs due to mutation; the genetic information stored in the DNA is changed. As the result the affected cells divide continuously and cause the formation of tumors. The cell repair machine that is as small as a nanoparticle can easily penetrate into the cancerous cell and repair the damaged DNA. As the technique is completely non-invasive, therefore the normal cells remain unharmed.

HISTORY OF NANOTECHNOLOGY
In 1974, Norio Taniguchi of the Tokyo Science University, defined the term nanotechnology for the first time. According to his definition, nanotechnology encompasses separating, processing, consolidating and deforming matter at atomic and molecular scales. Although the term nanotechnology got its definition in 1974, the actual concept was introduced way back in 1867, when James Clerk Maxwell proposed a minuscule entity called Maxwell’s Demon that was capable of handling individual molecules.
Richard Adolf Zsigmondy was the first person to observe and measure the dimensions of nanoparticles. He was also the first person to use nanometer for characterizing the size of the nanoparticles unambiguously. He determined that 1 nm was 1/1,000,000 millimeter. He also developed the first classification system that was based on size of the particle that ranged in nanometer.

In the 20th century several developments took place that helped in characterizing nanomaterials. Like in 1920, Irving Langmuir introduced the concept of monolayer, where a layer of material is just one molecule thick. He received a Nobel Prize for this concept.
In 1959, Richard Feynman, at a meeting of American Physical Society at Caltech, put forth a process that had the ability to control and modify individual atoms and molecules. He stated that by scaling down the dimensions of the atom, dramatic changes can be brought about in its properties. After the discourse, he announced two challenges; first was the construction of nanomotor, which achieved by William McLellan in 1960,and second involved the process of scaling down the letters of Britannica Encyclopedia to fit on the head of a pin; this task was accomplished by Tom Newman in 1985.
In 1965, Gordon Moore made an astounding prediction; he stated that the number of transistors that could fit in a specific area would double every 18 years for the next 10 years. Till this date the trend is continuing, from 2000 transistors in 4004 processors to 7,000,000,000 transistors in Core 2, and Gordon’s prediction is popularly known as Moore’s Law.
In 1974, Dr. Tuomu Suntola et al. patented the atomic layer deposition process. Through this process it became possible to deposit uniformly thin films, one atomic layer at one time. In the 1980s, nanotechnology no longer remained stochastic, but became deterministic. During this period, Dr. K. Eric Drexler advocated the significance of nanomaterials and devices.

So much of groundwork on nanotechnology made the process of production and implementation of nanomaterials relatively simple.

New Healthcare Technology and Personalized Medicines

More and more, diseases are being defined at the molecular level. Many diseases and patients’ response to medicines are influenced by the presence or absence of certain gene variants to a larger or lesser degree. Knowledge and better understanding of disease and of the genetic differences among patients is an important aspect of more personalized healthcare, which holds much potential for the future. For example, pharmacogenetics (medicines tailored to individual patients) should help develop more personalized treatments.

Personalized healthcare could bring more benefits for patients in terms of improved health outcomes, improved patient safety and reduced side-effects as well as better prescribing efficiency which will result in cost-effective practices for health services.


Much Thought Of More Innovation Friendly Regulatory Framework:

- Fosters the promises of new and emerging healthcare technology developments and personalized medicines in a responsible manner.
- Recognizes the opportunities related to evolving and emerging technologies.
- Recognizes that pharmacogenetic research and other innovative technologies must be integrated into an appropriate regulatory framework that fosters the development of treatment options, in particular of personalized healthcare.
- Promotes the application of research findings into clinical practice.
- Ensure adequate data and marketing protection for personalized medicines.
- Ensure public information and understanding of the potential benefits from these new and emerging technologies in order to avoid misinterpretations.

HURDLES OF PERSONALIZED HEALTHCARE

Only few personalized treatments are available for patients. Some of the factors hampering personalized healthcare from concept to reality are:

- The high cost of validating response-predicting molecular diagnostic tests to suitable clinical standards.
- The low reward for innovation.
- The low odds that any particular set of marker will be sufficiently sensitive and specific to justify its application in clinical practice. This makes the effort of finding meaningful biomarkers overall expensive.

New approaches and emerging health technologies, such as personalized treatment, are evolving more rapidly than legislation, leaving some areas uncovered by law or covered by outdated legislation.

NANOBIOTECHNOLOGY
Nanotechnology is widely anticipated as one of the key technologies of the 21st century. As an enabling technology, it does and will increasingly impact other technologies but also products including innovative diagnostic tools and medicines. For any technology, benefits and risks of nanotechnology have to be evaluated and will share consumers’ and patients’ interest in its safe application. Research-based biopharmaceutical companies continuously evaluate new scientific developments and innovative technologies as well as their potential application to the development of novel medicinal products. As part of the drug development process, nano-scale drug delivery systems and other nano-technology components of new medicines will undergo the same careful scrutiny that is applied to all new medicinal products with regard to both, safety and efficacy. This rigorous investigation and in-depth study applies to both preclinical and well-controlled clinical studies.