Biopharmaceutical Plants and Pharmaceutical Engineering

Among the many branches of pharmaceutical engineering Biopharmaceuticals is one of them, which develops medicines using biotechnology concepts. Biopharmaceuticals plants use living organisms and biological sources which have abundant of these substances which are used in production of medicines.

There therapeutic proteins which are restorative and secure have huge demand because they have a good healing powers and also they can be used in the production of prominent medicines. Over the past two decades, Biotechnology has gained lot of momentum and popularity in the medical world. The agents which stimulating red-blood-cell, insulin and growth hormones, etc, are vastly used in prevention of many diseases like orphan diseases, arthritis, multiple sclerosis etc.

Biotechnology

These plants use the concepts of biotechnology in production of all important drugs. With the development of pathogenesis, which can give reliable solutions to all fatal diseases, the life expectancy will be improved. Biopharmaceutical products can be used to efficiently treat various illnesses and traumas. This biotechnology requires huge investments and longtime development plan.

Biopharmaceutical Plants and Pharmaceutical Engineering

Production costs of the medicines needs to be reduced by adopting efficient methods in biopharmaceutical plants, also additional safety procedures need to be implemented.

Blood disorders and oncology which jeopardize normal like of mankind can be cured with using vaccines and other anti-infective agents; this treatment is available only because of biopharmaceuticals.

Various methods and strategies have been published describing effective production of biological substance by many healthcare organizations. All these methods and strategies are useful in the manufacturing process of various medicines. Biopharmaceutical plants produced various useful medicines which are highly effective to cure general as well as fatal diseases; they are still working hard to contribute more to the medical world.

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For more information on Biopharmaceutical Plants Biopharmaceutical Plants Exposure to hazardous drugs please visit the mentioned website.

Lean Six Sigma Benefits Pharmaceutical and Biotech Industries

The processes used by P&B companies may be quite different from that of other types of manufacturing and services industries, but that has not dented the applicability of 'Lean' concepts - because 'Lean' makes way for reduced costs and improved quality, which have universal applicability, especially in today's highly competitive globalized world.

For better understanding, let us discuss some of the critical areas where 'Lean' concepts and methodologies can be successfully implemented in pharmaceutical and biotechnology companies.

Biotechnology

Drug Research and Development (R&D)

Lean Six Sigma Benefits Pharmaceutical and Biotech Industries

Research and development is the backbone of every successful P&B company, and since R&D costs form a major chunk of the overall costs of such companies, it makes sense to deploy Lean concepts in R&D. By using time-tested Lean concepts and statistically sound methods, P&B companies can easily achieve the desired objectives such as identifying processes that are critical to the drug discovery and development, assessing the applicability of new processes and streamlining existing processes.

It is necessary for P&B companies to achieve these objectives because it is only then that they will be able to make way for increased capacity utilization, increased productivity, reduced drug failures, and the best possible use of existing staff, facilities and resources.

Cycle Times

Increased cycle times can easily hamper the successful launch of new drugs and other clinical products, technologies and applications, because in today's highly competitive P&B industry, getting the advantage of being first makes all the difference between success and failure. If a P&B company is infested with increased cycle times, it will not be able to make the first moves and chances are also high that competitors will come in to take its place by offering something very similar.

This is why it is necessary to use Lean concepts and methodologies such as 'value stream mapping', and 'process modeling' that not only help in reducing cycle times, but also help in reducing operational costs and improving operational efficiencies.

Defects

The defect or failure rate is probably the highest in P&B companies because drug discovery and development is still a gray science, wherein even small variations can have a huge impact on the final outcome. If standardized tools, techniques, processes are not used, it will become quite difficult for P&B companies to develop the desired drug or other clinical products.

'Lean' concepts such as DFSS (Design for Six Sigma) can help because they make use of time-tested scientific and statistical tools that automatically reduce the probability of human as well as process errors.

For better results, P&B companies should start with small 'Lean' projects that can be implemented with minimum costs and resources. They should give the go ahead for organization wide 'Lean' deployments only when the initial project starts to deliver the desired results. Better still, they should wait a little longer, preferably four to six months, before giving the final go ahead. This way they will be able to ensure the applicability of the selected 'Lean' project.

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Tony Jacowski is a quality analyst for The MBA Journal. Aveta Solutions - Six Sigma Online ( http://www.sixsigmaonline.org ) offers online six sigma training and certification classes for lean six sigma, black belts, green belts, and yellow belts.

An Overview of Pharmaceutical Contract Manufacturing

Pharmaceutical contract manufacturing is the process of outsourcing the work of manufacturing medication such as pills, tablets and capsules for consumption. It may also entail drug development processes and even regulatory support to help with the lengthy approval needed for a drug to be released on the market.

This process is actually a necessary one, not only for multi-million dollar pharmaceutical companies, but also for smaller groups and businesses that need the support of an outside facility which is equipped to handle the needs of the manufacturing course.

Biotechnology

For companies and businesses, contract manufacturing means that they can have the time and means to focus more on the business and management side of the industry. At the same time, they can also save costs from the complex methods of drug manufacturing. Thus, contract manufacturing is a boon for the field of pharmacy and biotechnology. It saves time and money.

An Overview of Pharmaceutical Contract Manufacturing

Besides that, for industries of pharmacy, food and drink, there are firm regulatory boards that have to approve new products. With the assistance of a pharmaceutical contract manufacturing firm that knows this well, a company can actually benefit from technical know-how on what formulations or manufacturing processes are best for a product to be approved, whether it is only for clinical use or for commercial release.

Finally, reputable pharmaceutical manufacturing firms hold themselves to good manufacturing practices or GMP. Not only does adhering to these practices make it easier for the products they manufacture to pass regulatory approval, but it also assures clients of their dedication to providing only the best for the good of pharmaceutical and biotechnological advancement.

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Pharmaceutical Research & Development

With the advent of technology and owing to the advanced and deep research, an array of drugs is released into the market that addresses a variety of illnesses. Contract Research and Product Development companies play an important and vital role in this. They assist the Biotechnology and Pharmaceutical companies with respect to many avenues.

Right from undertaking feasibility studies to selecting the exact dosage form design, these research companies provide vital and essential aid. The other services include analytical study, physical and chemical characterization using advanced laser technology, Nanotechnology, evaluation of devices and much more. The expert staff and researchers are always in pursuit of developing new and effective technologies and the stress is always on out-of-the-box or innovative approach.

Biotechnology

As mentioned earlier, the different forms and types of dosages developed, here is a list of few:
- Inhalational: Nasal, Spray Metered dose inhaler (MDI), Dry powder inhaler (DPI) and Nebulizer
- Oral: Tablet, capsule, pill, Solution and suspension.
- Topical: Gel, Patch, Cream, Lotion, Paste, Ointment, liniment and Drops
- Parenteral: Nebulized Solution and Intrauterine Catheter.
- Others: Water-soluble and - insoluble compounds, Stable and unstable compounds, Liposome and Inclusion complex.

Pharmaceutical Research & Development

The extensive services offered by Contract Research and Product Development companies include:
- Analytical and feasibility studies that help you in selecting the apt and correct dosage form.
- Compiled and thorough studies that take into consideration the compatibility of active ingredients excipients, delivery components and the components to be used in packaging.
- Design of the dosage form
- Optimization of the drug formulation
- Selecting the appropriate flavors or use of flavors to mask the taste.
- Characterization of the formulation
- Decide the bottle or storage form that will eventually store the product (tube, bottle etc).
- GLP Tox Batch Manufacture
- Process Scale-Up
- Stability Studies

These processes are under the supervision of experts and is also based on and supported with case studies and statistical data.

Skilled/Experts:

Contract Research and Product Development companies hire experts and scientists that further enrich the process. Unlike the Biotechnology and Pharmaceutical companies they do not have to tackle or deal with other issues, so focus is completely on research and drug development. An expert of that particular domain or field ensures a wise and sound decision with regards to that you can avail experts in the fields like Product Performance Evaluation, Microformulation, Taste Masking, Improved Delivery System Development, Increased Efficiency of Product, Bioavailability enhancement, Excipient Selection and Compatibility and much more.

A host of services offered by the Contract Research and Product Development companies result in better and improved product development. Apart from that it also offers other services like Analytical Studies and Method validation.

By employing these companies, the Biotechnology and Pharmaceutical companies get the benefit of expertise at their disposal. Also, thorough statistical data and case studies are presented. The use of advanced technologies and equipment like laser not only expedites the process but also increases efficiency and accuracy. With lesser turnaround time and effective cut In expenses the client firms can focus on other issues and problems.

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Pharmaceutical Industry in India, Top Pharma Companies and Jobs

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Pharmaceutical companies in India are growing at a very fast pace and this has made the Indian pharmaceutical industry as the second largest growing industry. Also the pharmaceutical industry in India is the third largest in the world, which will be of US$20 billion by 2015. Mergers and acquisitions are the part of this growth. The compounded annual growth rate of pharma in India is 12-15% and the global figures are 4-7% for the period of 2008-2013. With such a profound growth of pharmaceutical companies in India numerous pharmaceutical jobs can be seen. This in turn is helping biotechnology industry and booming the biotechnology jobs in India.

Angel Broking has done a research on the growth of pharmaceutical industry and found that by 2015 the pharmaceutical industry in India will be in the top 10 markets. Yet another finding of FICCI-Ernst & Young study reveals that the population of high income group in India is rising which will give rise to more influx of MNCs and expensive drugs.

Pharmaceutical companies along with native companies are also competing with the top MNCs. Such a profound growth is because of the heavy population figures and with the increasing number of middle class people and their income the access to drugs and medicines is also increasing. But still the low-priced generics are popular in Indian pharmaceutical industry.

From India in year 2007-08 total of US$ 8.25 billion were exported and there was seen 29% rise in this figure in 2009. MR Anand Sharma, Union Minister of Commerce said that pharmaceutical sector in India has grown and it is the major contributor to exports from India. In 1990 the amount was meager as compare to today's massive figures.

Initiatives by Government

1. Tax breaks are offered to pharma industry


2. New procedure for the development drugs


3. Proper clinical procedures


4. New Millennium Indian Technology Leadership Initiative and the Drugs and Pharmaceuticals Research Programme - Two schemes launched by the government.

Some Vital Information on Pharmaceutical Companies in India

• In terms of volume - India's pharmaceutical industry is the third largest in the entire world.


• In terms of value - India's pharmaceutical industry ranks fourteenth


• By 2015 - It will be in the list of top 10 global pharmaceutical markets and it will touch US $ 20 billion.


• 2008-2009 - Saw 29% growth in exports of pharmaceutical drugs as compared to 2007


• 2013 - Indian formulation market is expected to touch US$ 13.7 billion

Top 10 Pharmaceutical Companies in India

• Ranbaxy


• Dr Reddy's Laboratories


• Cipla


• Sun Pharma Industries


• Lupin Labs


• Aurobindo Pharma


• GlaxoSmithKline Pharma


• Cadila Healthcare


• Aventis Pharma


• Ipca Laboratories

R Oberoi is associated with Manpower from India and recommends http://www.manpowerindia.net for searching and finding information on all kinds of jobs.

Pharmaceutical Engineering and Biopharmaceutical Plants

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Biopharmaceuticals is one of the related branches of pharmaceutical engineering. This branch uses the concepts of biotechnology for the development of medicines. These plants mainly use the living organisms and biological sources that are rich in those substances that can be used in developing useful medicines.

The therapeutic proteins that are restorative and secure are in high demand as they have great healing capacity and can be used for the manufacture of important medicines. In the last two decades, Biotechnology has earned a lot of popularity and is now ruling the medical world. The red-blood-cell stimulating agents, growth hormones and insulin etc are heavily used in the preclusion of several diseases such as various orphan diseases, arthritis, multiple sclerosis etc.

In biopharmaceutical plants, almost all the important drugs are produced using the ideas of biotechnology. The life expectancy can be greatly amplified by the progression of pathogenesis that can give efficient solutions to almost all life- threatening diseases. Using biopharmaceutical products, efficient treatment of innumerable diseases and traumas have been made possible. But the fact is that, it requires large investments and prolonged development time. The production costs can be significantly reduced by the production of efficient biopharmaceuticals in the plants with an additional advantage of higher safety. Blood disorders and oncology that are a menace to the mankind can be effectively cured by the help of vaccines and other anti-infective. This has been made possible only by the biopharmaceuticals.

Different healthcare organizations have published numerous strategies that can be used for the effective production of the substances that are biologically active. All these strategies are very important and useful in the production process of different important medicines. Biopharmaceutical plants have developed many useful medicines that can effectively fight against both common as well as crucial diseases and are still thriving hard to do more for the medical world.

For more information on Pharmaceutical engineering and the benefits of Biopharmaceutical plants please visit the mentioned website

The Boom Of Pharmaceutical Engineering

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Before 1970, the word Pharmaceutical engineering was non-identifiable but now the scenario has been totally changed. The one and only answer to all the adversities faced by business enterprises is Pharmaceutical engineering which has the capacity to fight with all the competition and proove its ability.

Global economy has a negligible affect on Pharmaceutical engineering as it deals with all medical liabilities and the major contributor of all health care products and services. It has incredible future in the business sector due its never ending growth.

All the wonders created in the world of medical science is possible only due to Pharmaceutical engineering. It has the potential to fight with the major vital diseases. The engineers have made the word impossible as possible by developing the solutions for the most deadly and non-curable diseases. But this is not the end; the Pharmaceutical engineers are consistently progressing in their respective fields and are continuously doing research to find the ungiven answers.

In the world of medical science, they are not only proving themselves in the field of drug discovery but also in the fields of Biotechnology, nutrition, nanotechnology, biomedical science etc they are showing their proficiency and proving their worth. There is a consistent requirement of these skillful engineers in the healthcare sectors for drug processing, drug development, R&D of new medicines, etc.

For survival of the fittest in this challenging world, health and fitness are the two crucial terms which needs the maximum attention. For dreadful diseases, age is no bar and everybody becomes its victim so Pharmaceutical engineers are extending there helpful hands to them by creating drugs which can fight with these non curable diseases. Delivery of drugs is also done by these engineers so that the needy people get it within time. Hard work and patience are the criteria's for these engineers as this branch of science is involved in the discovery and development of future medicines.

For more information on Pharmaceutical engineering and the benefits of Pharmaceutical engineering please visit the mentioned website.

REACH Regulations and Its Impact on Indian Pharmaceutical Market

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European Union has opted for the acceptance of REACH regulations on 1st June, 2007. REACH stands for Registration, Evaluation, Authorization and Restriction of Chemical. The regulation is adopted for streamlining and improving the former legislative framework on chemicals of the European Union. The regulations has put the Burden of Proof" on the industry to manage the risks that chemicals may pose to the health and the environment. REACH regulations covers not only industrial chemicals but also chemicals, which are used in our day-to-day life (e.g. paints, dyes used for clothing, etc.)

Objectives of implementing REACH regulations are:

* Improve the protection of human health and the environment from the risks that can be posed by chemicals
* Enhance the competitiveness of the EU chemicals industry, a key sector for the economy of the EU
* Promote alternative methods for the assessment of hazards of substances
* Ensure the free circulation of substances on the internal market of the European Union.

All the exporters and importers of chemicals will identify and manage the risks and hazards associated with the chemicals that they manufacture and market. REACH requires manufacturers and importers of chemicals to produce data on all chemical substances that are produced or imported into the EU in volumes above one ton a year. Appropriate risk management measures must also be identified and users informed of them.

REACH regulations are imposed on manufacturers or importers of chemicals of more than 1 metric ton per annum per company. For companies who are manufacturing and exporting more than 1 metric ton of a chemical to Europe will need to register the chemical by submitting the dossier and proving that the chemical is safe to use. Potential registrants (i.e. manufacturers and importers of chemicals) must 'pre-register' these substances by December 1, 2008. Those that are not pre-registered by that date will have to undergo a full registration process in December, or be withdrawn from sale. Supply of substances to the European market, which have not been registered, would be considered as illegal.

REACH regulations are managed by European Chemicals Agency (ECHA), which will operate from Helsinki, Finland.

Although, REACH regulations cover all chemicals, exemptions are provided for medicinal products. Hence, all active pharmaceutical ingredients (APIs) and their finished dosage forms are exempted from the cover of REACH regulations.

There are many companies in India, which manufacture and exports intermediates for APIs to clients in European countries. Indian companies consider intermediates for APIs as a huge market. As intermediates for APIs are not classified as medicinal products, hence are not exempted under REACH regulations. Intermediates for APIs need to be pre-registered before the deadline of 30th Nov, 2008 and then processed for its registration procedure.

Intermediates for the APIs can be classified again under 2 main categories under REACH:

* Non-isolated intermediates
* Isolated intermediates
* On-site (non transported) isolated intermediates
* Transported isolated intermediates

A non-isolated intermediate is an intermediate that during synthesis is not intentionally removed (except for sampling) from the equipment in which the synthesis takes place.

On-site isolated intermediate means an intermediate not meeting the criteria of a non-isolated intermediate and where the manufacture of the intermediate and the synthesis of another substance from that intermediate take place on the same site, operated by one or more legal entities.

A transported isolated intermediate is an intermediate not meeting the criteria of a non-isolated intermediate and transported between or supplied to other sites.

Under REACH regulations, non-isolated intermediates are exempted from review process as non-isolated intermediates remain in the reaction process and are not isolated.

Most of Indian pharmaceutical companies exporting intermediates for APIs would fall under the perview of the "Isolated intermediates" category for which the companies will need to undergo review procedure under REACH regulations.

Relief under Strictly controlled conditions:

For both on-site and transported isolated intermediates, there is possibility to provide a reduced set of information for their registration under the following conditions:

* For on-site isolated intermediates, the manufacturer confirms that the substance is only manufactured and used under strictly controlled conditions in that it is rigorously contained by technical means during its whole life cycle.
* For transported isolated intermediates, the manufacturer or importer confirms himself or states that he has received confirmation from the user that the synthesis of another substance from that intermediate takes place on other sites under strictly controlled conditions.

Adding to the above-mentioned brief overview of REACH regulations, all the steps of registration under REACH regulations are expensive as all the products (other than exempted products) need to be registered individually.

In conclusion, impact of REACH regulations in India's Pharmaceutical sector would

* potentially disrupt the supply of intermediates for APIs
* push up drug prices.