Advantages Of The New Technology

Published Date: 02 Nov 2017

This business plan focuses solely on commercializing a technology that already exist for pharmaceutical and a biotechnology called bio therapeutic with a much more completive prices in the uk as the current technology on the market is expensive, this business that can be established quickly as the technology for producing is available, is easily quantified also require minimal capital investment is required, also is expected to be profitable and cash positive quickly as the market for the product is worldwide and more and more people are using bio therapeutic products.

The benefits that’s would be gained by the company due to the commercialization of the technology will be done by the company or through other licenses. All new methods researched will be panted also the company will also be using a exiting technology such as the biotechnology a the environmental issues very important for the company.

Advantages of the new technology

The company will be used to acquire a patent assignment for any new development made and a further patent for the final products also an exclusive license such as gold standard will be obtained , with a next generation inducible gene regulation technology key to our company. Also the company will also need a world class isolation and purification technology or establish a business with a existing company such as "biogene" for the safety of our products and more important the safely of our customers.

Key differentiators

Chemical inducer molecules that’s are improved: Establishing a relationship with a company that specializes in chemical inducer molecules, the company hopes to make a more cheaper and non-toxic to mammals chemical inducer molecules by doing this the cost of the products will be highly decreased as the manufacturing cost is reduced.

Due to the tight Regulation of Expression: the chemical inducers and their response elements are highly specific and also extremely selective, the company’s gene expression is knew to be undetectable in the absence of the chemical inducer and with this technology therapeutic proteins (cytotoxic proteins) can be made that were not able before the technology was available with the current generation technology.

Receptor pairs and inducers: The current available inducers and receptors that’s on the market are of mammalian origin but further modified and engineered inducers and receptors will have to be made with selective pairs but with a reduced manufacture .

Bioactive Yield and gene expression

The bioactive yield and the gene expression are closely controlled, by controlling the gene expression would allow the gross yield to be optimized without the risk of exceeding the recommended post translational modification of the capacity of the host cell , also by not exceeding the post translational modification would maximum the fidelity of the desired human protein , insuring the bioactive yield is maximized.

System Optimization of the host

With the company new and improved technology such eukaryotic hosts such as mammalian cells to be produced also cells like fungi and other insert cells to be produced.

Purification and Isolation

Isolation and purification technology will be based on research and using specialized companies such as "bio gene" .The modified and improved in the technique will insure the chromatography will involve a simulated fix bed process which has proven from research to be more effective compared to the current moving bed process.

the company competitive advantages

The joining of the technologies of bio technology and the existing therapeutic will result in the having a significant increase in the market product yields due to the reduced costs of the products due to the upstream production and the downstream purification systems , also having a close relationship with existing company’s such as " bio gene ". In the research development department the company will insure a exclusive opportunities for the drug testing candidates with a state of the art facilities. An exclusive patent will be acquired by the company to insure the process and products are not easily copied by other companies.

THE BUSINESS MODEL

By targeting both pharmaceutical and the biotechnology companies as customers will insure that’s the therapeutic proteins products have a large market to be introduced in ,and with the completive prices and products will also insure that’s the company products will challenge the current products on the market. The customers (pharmaceutical and the biotechnology companies) will hold an exclusive intellectual property on the products.

The process development by the company will be done by the continuously clinical quantities which will give the company a continuously improved drug development which meets the approval process. After the initially drugs have been launched on the market the technical support and the manufacturing technology for the products will be given to the customer (pharmaceutical and the biotechnology companies) will continue further development on a milestone basis.

by having the approval from the regulatory authorities of the products , licences will be sold to the customers for the right to use the company’s new technology for producing products on a commercial scale by the customer themself or a third party contract manufacturing company working for the customer. The pricing and the terms of the licenses will be very much consistent with those in the industry giving the company a competitive edge, the Company the will purchase these licenses will receive a share of the economic benefits that will be achieved with the Company’s exciting technology.

The technology produced by the company will be sublicensed to large biotechnology companies by a product specific basis also on therapeutic type class basis. The prices of the licenses will be based on milestones and royalty basis which will be reduced as a reflection to the company’s reduced costs meaning the company could obtain all the rights for the future developments. The isolation and purification of the company will be done by obtaining contracts with chemical and pharmaceutical companies , where the price will be on a per gram or kilogram basis , also the company will be also producing products and selling them at a discounted prices.

The Company will also pursue opportunities to finding advanced bio manufacturing and isolation also purification technologies to insure the company is always ahead of the market in terms of the technologies used.

the marketing department will seek for strategic partners on a sales agency basis also giving an opportunity for them to earn commission percentage on sales, also the bio manufacturing opportunities that’s may arise can give the company a diversity in the products.

Advantages of Business Model

The diversity of customers and the products that will be produced will limit the Company's risk. The company's will have a wide variety of products which will target a large number of customers in the pharmaceutical and bio technology industry. For example the gold standard exclusive, also the next generation technology obtained by the company and the following advantages:

Yield improvements,

Ability to make cytotoxic proteins,

inducers that are non-toxic and non-pharmacologic

Will keeping a significant competitive advantage continuously improving and modifying is key as the economic issues differs from day to day.

OBJECTIVES.

Producing at least three products in year one, six products during year two, nine products during year three all milestones will be continuously edited during the year based on the performance of the company.

Selling two new product-specific licenses with a biotechnology company,(giving the customers a reduced royalty and an exclusive right to use the technology from the company) for the first year.

Obtaining a contract with a purification and isolation company that does specialize in that area such as (bio gene).

MARKET ANALYSIS

The biotechnology industry and the pharmaceutical industry have researched and identified promising large molecular weight human protein candidates which can be used for the testing; the current commercial of bio therapeutic manufacturing remains very small on the market as the technology that’s is available is still very new and quite expensive. In addition, the cost of manufacturing the current technologies remains very costly meaning that’s many people can’t afford to the technologies.

Based on research there are large number of biotechnology drugs on the market from pharmaceutical and biotechnology companies that are active, the capacity and the amount of revenues that can be achieved by a biopharmaceutical contract manufacturing companies have double from 2006 and will carry on increasing. These companies are rapidly adding to capacity stating that the demand for such type of company is increasing year by year, the demand of the market is expected to reach about two million litres a year. More and more companies are seeking to improve on their productivity of the current capacity by the improved expression a system, that’s the market where the new technology fills in the market.

The improved productivity will in the short term will use a large amount of capital cost but will produce the amount that is needed for the demand having a short payback time, the current commercial scale cell production train for the manufacturing of the therapeutic protein will the added human gene addition will cost between £100 and £150 million . The technology that’s would improve the current productivity will also affect the substantial value of the cost.

On the current market there are small molecule drug products making a very competitive market, meaning that to obtain sales in the current market the pricing of products should be competitive with the small molecule drugs products.

The problems that affect the cost of the products:

Mammalian cell manufacturing systems tends to be very low – 280 mg/l to 400 mg/l. But with research the current technology to date has a 1000mg/l to 1100mg/l making it the perfect amount for making less costly products also making it compatible with the best systems only yielding at 1000 mg/l to 1500 mg/l.

The control over the protein expression is quit poor and the expression levels exceeds the post translation modification capabilities of the host cell. Research made found the fidelity can be modified to increase the induction of the immune system response in the patient. The current technology shows the raw yield is typically similar to the net yield.

The company improved technology and the improved control will increase the bioactive yields in the cell culture systems at a raw yields equalling or exceeding the technologies on the current market. By having this new technology will offer a reduced manufacturing cost also will reduce the price which will be offered on the market.

The production of bio therapeutic products is very critical as any changes in the production would increase the cost of the products. The current availability of the capacity if reduced could potentially block the path to the market for the products. The cytotoxic protein products have a little capacity in the current technology because these large amount or capacity is in large amounts but the company further research has been found which will generate an expression system.

The ways in which manufacturing the products can be eased are as follows:

Target protein yield

More enhanced biological activity

More reduced culture cycle time.

The ways in which these goals can be met, either

Improving existing expression systems by developing a better host strains, also by improving the induction kinetics and optimizing media to performer, having a better understanding of the nutritional requirements, having a more developed next generation expression system.

The issues that affect the developing improved expression systems.

The issues is cost the of developing a company’s technology to the technology that is need for producing the best products is typically around 20 million in development capital , much of the science goes to inductive gene expression.

TARGET CUSTOMERS

Large Pharmaceutical Companies

Large pharmaceutical companies in the current day are manufacturing from outsourced factories and plants in different countries. The cause of this is the cost of the research and development and marketing and distribution kept of increasing so large manufacturing companies sees as not a financially feasible way to use the capital to the rate of return on investment.

Small drug companies contribute of 90% of the aggregate sales of pharmaceutical products having a annual return of £250 . In 1999, 75 new biotech drugs and vaccines and indications where approved and with the current trend continues to grow where it is now the projected sales of new biotechnology therapeutics products are expected to reach or go past £86 billion annually by 2025.

Large Biotechnology Companies

Large pharmaceutical companies and some large biotechnology companies have integrated commercialized and increased the scale for bio-therapeutic manufacturing capacity. The customers for these large pharmaceutical and biotechnology companies are not likely to have direct word on the process development. The company's new technology has a significant value to these customers. The uniqueness of the technology gives it an advantage, such as the potential to make cytotoxic proteins in large amount. The will also license the technology’s for the entire therapeutic classes.

Biotechnology Companies

The biotechnology companies involved in the drug discovery will hold a in license also would coordinate the drug discovery also the product development and manufacture the products for suppliers .The relationships with the customers for these biotechnology companies is very similar to the customer relationship with large pharmaceutical companies it only differs on the pricing where small companies calculate the risks and price on the risk value.

TARGET PRODUCTS

Generally, the Company's customer has the right to identify the products to be manufactured by the company. There are several general classes which the customers would be able to pick that merits the decision.

Cytotoxic Proteins

The Company knows the technology from the company have the capabilities have the greatest value in the manufacturing of cytotoxic proteins because of the competitive advantage that’s the company’s technology’s brings to the manufacture of the products.

Non-Cytotoxic Proteins

Non cytotoxic proteins are the company’s main products and are the core of the business plan and the projections. There are very amount of these products are still being developed by large pharmaceutical and bio technology companies, there are of area of interest because the demand is very high.

The Proteins Generic

Bio therapeutic products already exist on the market that’s are already being manufactured but there quit expensive. The products on the market are currently being made in a bacterial system, although there being made in a bacterial system they could be converted to mammalian cell systems. Changing a manufacturing process of commercialized pharmaceuticals is not very cost effective and the cost and the risk overweigh the benefits for cost.

MANUFACTURING FACILITY

The Company will locate its operations in a technology in china built to suit. A china location is necessary as the isolation and purification technology is based in china. A china company also building the company in china would provide less manufacture cost compared to building anywhere else. The company will rent two small offices and two laboratory areas

Two 600 litre bio-manufacturing units will be brought buy the company. They should be standard sized, skid-mounted units. Based on research from other company’s in this field and there design engineering specialists data in the biotechnology field, an estimate for the Company capital budget was believed to be £17 million is that’s will cover everything that is needed for the company which includes all the acquisition and installation units.

RESEARCH & DEVELOPMENT

The key company research will include customizing the systems for the use and manufacture of bio therapeutics, the company’s aims to improve and develop the current technology that is available. The development will include further research on:

Small molecule design

Optimization

Receptor design

The full research and development of the products was not added in this business plan due to much of the important and necessary research will be developed and funded by the customer (pharmaceutical and the biotechnology companies) also the purpose of this business plan is not for drug discovery research or to producing proteomics or immunotherapeutic.

Small Molecule Design and Optimization.

Further development on major program such as the following programme are key to the company as they would insure that the company is producing products of high quality and at the lowest prices possible

Ligand optimization

Synthesis

new and improved inducer ligands

The objectives and targets of small molecule programs

To optimize inducer, receptor binding and to create or modify new ligand and receptor pairs for the use of gene regulation system

The company will Continuously expand the range of physical and chemical properties represented in our inducer library

The development of new chemistries that will improve the gene expression system for the management of precise regulations.

Receptor Design and Optimization

To insure the performance criteria the receptor and optimization will have to be continuously being developed. The program will have a complex three dimensional structural modelling with a multiple development of novel receptors, and virtual inducer docking.

Milestones Revenue and Timeline and Isolation and Purification Capacity

The company’s financial projections are based on manufacturing of bio therapeutic which are based on milestones of the company are represented in appendix A.

The company will use a risk adjusted system to obtain a financial projection .These Risk Adjusted Values will adjust by the risk calculation which will calculate whether the product will be successful or it will fail , or even be abandoned by the customer before achieving the milestones of the company .

The company’s revenue projections

The revenues of the company are represented in appendix b where states the 5 year projection of the company.

Milestone Revenues.

The 5 years milestones revenues are shown on appendix A where the timeline and also the risk adjusted value are also shown. Appendix A also shows the company’s projected performance and the development that’s will happen also the pre commercial and bio manufacturing services are stated too . In year 1 the company will obtain two contracts, with four contracts in Year 2, and six contracts in Year 3, and in year 4 the company will obtained eight contracts and in year 5 the company will obtain twelve contracts.

The two types of license that the company will offer, the first licenses will offer the customer (pharmaceutical and the biotechnology companies) to use the company’s technology without the support or services from the company just the right to the technology that the company offer. The second type of licenses that the company will offer is for the customer to have a complete use of the company’s technology with the full support and services of the company.

The customers that will buy the company licenses will have to pay a license fees which are based on product specific. The cost of the license fee is based on (24%) on the Company’s standard milestone fees, which is the biotechnology industry operating margin. The business plan is for the Company to develop and begins pre-commercial manufacturing before selling the licensing to customers. Each year the company will obtain one such contract each of the 5 years.

Companies that intend to purchase company’s technology for non-mammalian systems will be made to pay licenses for the full therapeutic class instead of those companies that use for mammalian systems. Three contacts in year 1 was assumed to be a smart target for the initially year of the company. The licenses obtained by the company will licenses further development on products for Future Revenues.

The approval of the products has a very long lead time which is represented on the milestone timeline in appendix A. The greatest revenue of the Company technology will be the selling of the licenses form the commercial manufacturing of the products from the customer. Appendix B represents that the company will receive 25% of the customers revenue. the calculation was conducted by the following assumptions , which are the annual sales for the customer to be £200 million with a 40% productivity improvement attributable to the new technology , with the average profit margin to be estimated to be 70% which was found from research of the pharmaceutical and biotechnology companies for 2008. The company has incorporated a monthly model for 5 years, which will be stated on a milestone basis and the company has estimated the present value to be 30%. 10% will be used as perpetuity as the customers also weighted average cost of capital.

Isolation Revenues

The isolation and purification will be sold in kilograms and also will be sold in capacity needed or used. The assumptions made and also from basic information the throughput needed will be 750 ml/min with the feed of 2.9gm/l in concentration 600 mg/l for bio-therapeutic products, with workers operating two daily nine shifts , five days a week and working 50 weeks in a year,