Optimum Selection of Pharmaceutical Intermediates can make your Manufacturing Business Profitable and Sustainable
Do you know Why some Pharmaceutical Intermediate Manufacturers are Flourishing in today&#;s Competitive Business Environment while others are Struggling?
Because their Businesses are based on Solid Foundation. And when it comes to Business Foundation, Product Selection is one of the most important Business Aspect.
They are selecting the right Pharmaceutical intermediate Molecules for their Manufacturing Business based on Integrated Product Selection Process
Before getting into the details, let me ask you an important question:
Do you know what&#;s the most important criteria to make any business successful?
It&#;s the Value Addition potential. Because unless the business adds significant value it can&#;t succeed.
Here your manufacturing business is no exception. Unless you add tremendous value in your pharmaceutical intermediate manufacturing business you can&#;t think of making it profitable and sustainable. Isn&#;t it?
Now the question is how to add tremendous value?
Making Medicines at Affordable Prices
When it comes to pharmaceutical intermediate manufacturing business, you can do it by helping the pharmaceutical industries become efficient. Then only they can make the life-saving medicines available to all at affordable prices.
Do you know why the medicines are so powerful and effective against the diseases?
It&#;s because of the active pharmaceutical ingredients. In fact, these active molecules actually fight with the diseases. In order to be effective, the medicines must be formulated with those active pharmaceutical ingredients.
But the active pharmaceutical ingredients must be manufactured at large scale in sufficient quantities at reasonable costs. Why?
Because in order to make medicines available to all of us at affordable prices, active pharmaceutical ingredients must be available at reasonable costs.
But how to do that?
That&#;s possible only when you manufacture high quality active pharmaceutical ingredient molecules at low costs.
When you get into the details of the manufacturing processes used in making active pharmaceutical ingredient molecules, you&#;ll find most of them involve chemical synthesis. Of course, some of the molecules are manufactured by other processes.
Irrespective of which manufacturing processes are employed, making active pharmaceutical ingredient molecules is challenging. Because the manufacturing process is complex and time consuming.
With chemical synthesis, process involves multiple reaction steps along with complex reaction mechanisms.
That&#;s why it makes business sense to make the manufacturing of active pharmaceutical ingredient molecules easy. Isn&#;t it?
That&#;s where the pharmaceutical intermediates become important.
Pharmaceutical Intermediates
Because with the pharmaceutical intermediates, the manufacturers of active pharmaceutical ingredient molecules need not start from the basic stage. They can carry out a few final manufacturing steps and the product is ready.
In short, active pharmaceutical ingredient manufacturers can concentrate on their core business.
When you talk about the Pharmaceutical Intermediates, they&#;re nothing but these Intermediate Molecules.
Let&#;s know more the Pharmaceutical Intermediates.
Based on their usage, they can be classified into two categories:
Basic Pharmaceutical Intermediate
When you get into the details of the basic pharmaceutical intermediate molecules, you&#;ll find them to be relatively simple. That&#;s why most of them are less expensive. They&#;re generally used in the initial steps of the manufacturing processes used for making active pharmaceutical ingredients.
Advanced Pharmaceutical Intermediate
When you get into the details of the advanced pharmaceutical intermediate molecules, you&#;ll find them to be structurally complex. That&#;s why most of them are expensive. They&#;re generally used in the final steps of the manufacturing processes used for making active pharmaceutical ingredients.
Before getting into the details of selecting right pharmaceutical intermediates, you need to know how they&#;re manufactured.
Manufacturing Process Details
If you study the manufacturing processes of pharmaceutical intermediates molecules, you&#;ll find four different types:
Based on the techno-economic feasibility, different manufacturing processes are used to make the pharmaceutical intermediates molecules. But when you get into the manufacturing processes employed in the industry, you&#;ll find most of them to be based on chemical synthesis.
Based on Chemical Synthesis
In most of the manufacturing processes, you bring about the molecular changes to the raw material molecules to make the products. And it results in molecular conversion. Here the raw material molecules are changed to the product molecules.
But when you&#;re using chemical reactions to bring about the changes in the molecules, you&#;re using the power of chemical synthesis. Of course, there&#;re different types of reactions to make different products. Naturally each reaction has its own process conditions along with the advantages and disadvantages.
You start with using chemical synthesis to make the products. But then the product molecules are still in the reactor along with other undesired molecules. T
hat&#;s why you need to isolate them in pure form. And you need suitable separation processes to recover them followed by purification processes to purify them. Because it&#;s necessary to make them suitable for the customers.
Based on Fermentation Process
With pharmaceutical intermediates especially the advanced intermediates, sometimes the molecules you want to make are too complex. Because of the molecular complexity, the chemical synthesis-based processes fail to achieve required molecular conversion economically. Then you need to think of alternatives like fermentation.
Fermentation process makes use of the power of the microorganisms. Specially developed microorganisms are grown in the fermentors under optimized process conditions in order to make those molecules. Of course, for different products you need different types of microorganisms.
Again, the fermentation process only makes the products. That&#;s why proper separation and purification processes become essential. This is to recover and purify the products from the fermented broth in order to make them suitable for the customers.
Of course, with pharmaceutical intermediates there&#;s additional advantage in using fermentation processes. Because the fermentation is a bioprocess, the products made by fermentation are chiral compounds which are difficult to make with chemical synthesis. Additionally, fermentation is a green process alternative.
Based on Enzymatic Reactions
When you study the metabolic processes in the body of the living organisms, you&#;ll find them to consist of enzymatic reaction. These biochemical processes are catalyzed by enzymes. That&#;s why enzymes are called biocatalysts.
Because of the advantages, enzymes are made by bioprocesses like fermentation and used as catalysts in molecular synthesis. In fact, when you combine the chemical synthesis and enzymatic reactions, the manufacturing process becomes highly efficient. They&#;re call chemo-enzymatic processes.
And the chemo-enzymatic processes are powerful enough to make complex pharmaceutical intermediate molecules economically and sustainably.
By Extracting from Natural Sources
If you search for special molecules, you&#;ll find that natural sources are the best option. Many useful products can be extracted from them.
When you analyze the compositions in the plant kingdom, you&#;ll be amazed at the product stock. Because the plants make many exotic molecules through enzymatic biochemical processes in the plant cells.
Most of the times, all parts of the plant like leaves, seeds, fruits, flowers, and barks are used to extract useful products. But the product recovery process is very complex. Because the plant feedstocks consist of thousands of molecules, you need proper separation and purification processes to achieve the desired product quality.
As we&#;ve discussed earlier, the product selection is important especially when you&#;re talking about the pharmaceutical intermediates. And Integrated Product Selection process can do justice to this important business initiative.
Integrated Product Selection
In today&#;s competitive business environment, the single most criteria for industrial success is to make your manufacturing process cost-efficient, environment friendly, profitable and inherently safer.
Then only you can think of making your manufacturing business profitable and sustainable. Isn&#;t it?
But everything starts with the product selection. Because product Selection is important for both new projects as well as for replacement of the existing products.
And when you consider the manufacturing complexity and specialized market requirements, the product selection becomes challenging. Because based on the type of the molecules, the manufacturing technologies are different.
And the quality requirements are very stringent. The pharmaceutical intermediates are considered to be building blocks of active pharmaceutical ingredients and so the product quality is important.
You must make those molecules which have got high demand in the market and fetch good prices. It&#;s important that these products match your manufacturing expertise and marketing capabilities.
You can use multiple routes of synthesis and different manufacturing technologies to make the molecules. But this makes the product selection difficult. In order to make your business profitable and sustainable you must consider important business parameters to evaluate the products.
Techno-commercial optimization following an integrated approach can help a lot here.
That&#;s why the molecule selection must be based on evaluation against important techno-commercial business parameters.
Let&#;s consider some business parameters:
Evaluate the Technical Feasibility
The technical feasibility is of utmost importance. Why?
As we&#;ve discussed earlier, manufacturing pharmaceutical intermediates at commercial scale is quite challenging. Because you need to make sufficient quantities of products at affordable costs along with meeting the product quality requirements consistently. Of course, you can&#;t compromise on the environment and safety aspects.
With pharmaceutical intermediates the customers are the manufacturers of active pharmaceutical ingredients. So, they&#;ll ask for high quality products.
When you talk about the process technologies, the manufacturing processes are important. Because the process must be suitable for large scale manufacturing.
In fact, technical feasibility is critical for the success of any process or product idea. And that&#;s why you need to focus on critical technical aspects to evaluate whether the manufacturing process technically feasible or not.
Some of the technical aspects you can consider are mentioned below:
Manufacturing Process must be Suitable of Commercial Scale
The manufacturing process must be suitable for large scale operation. Then only you can meet the business objectives. if you get into the details of the manufacturing process, you&#;ll be able to evaluate the process steps against important technical parameters
Some of the process aspects you can focus on are as below:
In short, the manufacturing process must be cost-efficient and operation friendly. The plant design should preferably use standard process industry equipment and systems. Because it&#;s not a good idea to design specialized devices unless the process demand is critical for manufacturing.
Optimize the Material of Construction
In designing the manufacturing facility for making pharmaceutical intermediates, the material of construction is very important.
Different type of process equipment and systems are used to carry out the different unit processes and unit operations at the commercial scale. Naturally the materials from which they&#;re constructed will depend upon the characteristics of the materials handled and the process conditions maintained.
That&#;s what makes the selection of material of construction challenging. Why?
Because the manufacturing processes vary a lot from product to product as they depend on the process technologies.
Of course, every process has its own material characteristics and so the corrosion potential. So, you need to select the material of construction so as to avoid corrosion which is essential for the long life of the plant hardware.
Sometimes the process conditions make the selection of material of construction difficult. Because if the process parameters involve extreme conditions, you need specialized process equipment using special material of constructions. This results in increasing the capital investment.
Process Parameters Maintenance
When you&#;re interested in operating the manufacturing plant at optimum condition, you need to maintain the process parameters properly. Because maintaining the optimum condition is critical for the success of the manufacturing process.
Some process parameters call for your attention:
Product Quality Requirement
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When the product quality requirements are very stringent, you need to ensure the technical feasibility very carefully. Because the product quality depends on multiple technical parameters. Sometimes it becomes very difficult to achieve the required product quality.
Some technical aspects you can focus on are as below:
We&#;ve already checked the technical feasibility. Let&#;s now talk about process safety aspects. Because the design and operation of the manufacturing facility must be inherently safer.
Safety Aspects are Critical
Most of the pharmaceutical intermediates especially the advanced intermediates are made by using multi-step conversion processes. Though most of them have high hazard potential, we don&#;t have any other option then to make the molecules at large scale even if there&#;re safety issues.
Safer Manufacturing Process
So, the best way is to make the manufacturing processes safer. We need to follow safety-based design by incorporating safety aspects in designing the manufacturing facility.
You can consider two approaches:
As you can see when you talk about manufacturing pharmaceutical intermediates, eliminating or at least minimizing the process safety hazards helps a lot. In fact, it&#;s very effective in the early stages of product or process development. Why?
Because in the early stages, the scientists and engineers associated with the process development and plant design have enough freedom to select the products and process technologies. In fact, they can always incorporate the technological advances to minimize the safety hazards to a great extent and make the process inherently safer.
That&#;s how you can evaluate the products against the safety aspects. Looking to the criticality safety aspects must be deciding in the product selection process.
Now, let&#;s talk about environmental sustainability.
Ensure Environmental Sustainability
Environmental sustainability is of utmost importance because most of the processes for making pharmaceutical intermediates generate significant quantities of waste. And most of them are pollutants impacting the environment badly. That&#;s why the pollution control becomes essential.
In that situation, how to achieve it economically is of major importance. Because the waste treatment cost plays a very important role in making the manufacturing process economically viable.
So, you need to go for minimization of waste generation and efficient waste treatment.
Minimize the Generation of Wastes
The most effective pollution control initiative is to minimize the waste generation. When you generate less waste, you need to treat less amount of waste. And you gain in two ways. Both the capital investment in building the waste treatment facility and the operating costs decrease significantly.
You can implement improvement initiatives:
When you go for integrated optimization of the conversion as well as separation and purification processes, you can reduce waste generation significantly.
And when you implement the resources conservation initiatives like Reduce, Reuse, Recover, and Recycling effectively, you can achieve significant reduction in the waste generation.
But as you can&#;t make the waste generation zero, you have to go for efficient waste treatment. So that you can make the wastes harmless to the environment.
Cost-Efficient Waste Treatment
Waste treatment in pharmaceutical intermediate manufacturing is very important. It starts with waste stream characterization and segregation of the waste streams based on their characteristics. Because it&#;s necessary to achieve economical waste treatment by using suitable treatment technologies for different waste streams.
Let&#;s now discuss about the most important aspect of any business &#; the business profitability.
Business Profitability is Important
When you go for pharmaceutical intermediate manufacturing business, you employ the resources to make the products. And you pay for buying the resources. As your products add value to the customers, they pay you at the market rate to purchase your products.
When the business is healthy the money you get from your customers is higher than the money you spent in arranging for the resources.
And the difference is Profit&#;
But how to check whether your business is profitable or not?
Market Demand
You must ask yourself critical questions regarding the market situation:
Of course, things are not certain. However, a careful market analysis can help a lot.
Let&#;s now talk about the other equally important contributor to the profitability &#; the manufacturing cost. In fact, the manufacturing cost can make all the difference between the success and failure of your business.
Manufacturing Cost
In order to evaluate this critical business aspect, you must focus on the total manufacturing cost.
Because, the manufacturing cost must include all expenditures. For that you must check all the cost components:
The cost of the Raw Materials
In manufacturing pharmaceutical intermediates, the raw materials cost must consider the costs of key starting materials, reagents, catalyst, solvents and other raw materials.
The cost of Energy
When you talk about the cost of energy, it will include the electricity and the fuel used for utility generation.
The cost of Waste Treatment
The cost of Waste Treatment will include the cost of raw materials and energy consumed in the treatment of the waste streams.
The cost of Finances
The cost of Finances will include the interest and depreciation based on the capital you&#;ve invested in building the manufacturing facility and other business investments.
Of course, there&#;ll be many other costs associated with the business. The idea is to consider all expenses in order to make the costing accurate.
When you select the pharmaceutical intermediate molecules, make sure to estimate the manufacturing costs and market scenario as accurately as possible.
Alternative Products
But considering the uncertainties, evaluate alternative products to achieve hundred percent plant capacity utilization even when your exiting products have lost their market.
With pharmaceutical intermediate, it&#;s important as the products are specific to the active pharmaceutical ingredients.
The aim is to utilize the manufacturing facility efficiently so that you can maximize the business profitability. Then only you can maintain the profitability even in difficult situations.
It&#;s important to go for complete evaluation for the additional pharmaceutical intermediate even if you&#;re not planning to make then in the near future.
Let&#;s Conclude
In order to build a strong business foundation for manufacturing pharmaceutical intermediates, you must select the right molecules to manufacture.
And the selection of profitable and sustainable pharmaceutical intermediates calls for careful consideration of multiple techno-commercial aspects:
Technical Feasibility
In order to check Technical Feasibility, you must focus on:
Process Safety
In order to ensure Process Safety, you must focus on:
Environmental Sustainability
In order to ensure Environmental Sustainability, you must focus on:
Business Profitability
In order to check the Business Profitability, you must focus on:
As all the Business Aspects are Interdependent, the Product Selection process must consider the critical business aspects in an integrated way.
Let&#;s join hands in using innovations in Selecting Pharmaceutical Intermediates and developing them further to make high-quality medicines available to all at affordable prices.
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Jul 30,
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Pharmaceutical intermediates are crucial compounds used in the synthesis of active pharmaceutical ingredients (APIs) and finished drug products. They act as building blocks in the production process, ensuring the efficacy, safety, and quality of medications. These intermediates are typically produced through chemical reactions and play a vital role in the pharmaceutical supply chain.
Pharmaceutical intermediates are chemical substances used during the manufacturing process of APIs. They are not directly used as drugs but are essential for the synthesis of the final pharmaceutical product. For example, benzyl alcohol and ethyl acetate are common intermediates used in the production of various medications.
Pharmaceutical intermediates ensure the quality and efficacy of the final pharmaceutical product. They are involved in critical stages of drug synthesis, impacting the purity and effectiveness of the medication. For instance, intermediates used in the synthesis of antibiotics must meet stringent quality standards to ensure the drug&#;s therapeutic efficacy.
The choice of intermediates affects the overall cost and efficiency of drug production. Cost-effective intermediates can lower production costs, while high-quality intermediates can enhance the drug&#;s performance. For example, using a more efficient solvent can reduce both material costs and processing time.
Connex Pharma is renowned for its extensive range of pharmaceutical intermediates and its commitment to quality and compliance.
For more information, please visit pharmaceutical intermediates supplier.