M.SC.

CHEMISTRY
FIRST SEMESTER
Course Code: 21CHE1S1LP

R&D and Quality control

www.vskub.ac.in
 Unit-I: Research and Development
Research & Development:
Importance, Process development & product development, In-house failure and
addressing; Design & executions of reactions.

Industry:
Types of chemistry related industries; Sections and responsibilities

Chemistry software:
ChemDraw®; SciFinder®; Computational Chemistry (Docking)

Production:
Control & Execution; Testing of In-house failure products.
Research & Development: Importance:

• Research and development, abbreviation R and D, or R & D, in industry, two intimately related
processes by which new products and new forms of old products are brought into being through
technological innovation.

• The concept of research is as old as science; the concept of the intimate relationship between research
and subsequent development, however, was not generally recognized until the 1950s.

• Research and development is the beginning of most systems of industrial production.

• The innovations that result in new products and new processes usually have their roots in research
and have followed a path from laboratory idea, through pilot or prototype production
and manufacturing start-up, to full-scale production and market introduction.
• Research and development is a key component in the successful discovery and development of new
drugs and medical devices entering the market.

• It’s also an area of big business, with investments in R&D experiencing historic growth year after
year.

• With such impressive growth comes a need for companies to have a sound R&D strategy.
Types of R & D:

There are three main types of research and development as defined by the National
Science Foundation:

Basic research is a broad approach to research that may not have specified end goals in
mind. The focus is on gaining knowledge, which can then be linked to a company’s stated
goals.

Applied research is a more defined approach with a means to an end in mind. A

company may have identified a specific objective and is now looking for ways to meet that
objective with a product or service.

Development is using research gathered in new innovations or in improving existing

products and services. The development process can also lead to additional paths for
research.
Why is Research and Development Important?

• The importance of R&D, particularly in the chemistry research and development space, is tangible.

• Innovation can lead to improvements in the overall synthesis of existing and new drugs to improve
human health.

• But research and development is also critical to the health of companies doing the research.

Important Results That Prolong and Save Lives:

• Consider the work being done with the genome-editing tool CRISPR-Cas9, a tool that could have a
wide range of applications in the treatment and cure of diseases that link back to genetics.

• This includes everything from cancer to high cholesterol.

• While challenges certainly exist, particularly in the effective planning and execution of research and
development programs, these programs’ value goes beyond innovation when run successfully.
Improve Upon Existing Products

• Once products such as new drugs or medical devices hit the market, the need for
continued research into the efficacy of those products continues.

• Research teams consistently monitor data to account for potential side effects, unknown
variables, or new applications for existing products.

• With the overwhelming amount of big data in medical science that emerges via R&D,
working with a resource management team helps ensure ongoing data management is
monetized properly.

• In the coming years, R&D will explode with the possibilities of personalization. Patients
are looking for personalized responses to their healthcare needs.

• The general public is becoming more and more aware of just how unique their genome
and physiologies are. Research and product development that focuses on a more
granular approach to health solutions will not only provide reliable revenue for biotech,
but better answers for consumers.
Economic Growth:

• Despite research and development costs, investment in R&D is critical for biotech to
remain competitive in the market.

• New, unique products mean fresh sales and fresh eyes on an organization, on top of tax
credit opportunities.

• Aggressive research and development strategies are then critical to a company’s

business plan.

• R&D also supports economic growth on a global scale in both direct and indirect ways.

• In the biopharmaceutical industry alone, R&D is a top driver of high-quality, well-paid

employment opportunities, generates revenue for a company through innovative
products, and can be an internal investment tool in statewide clinical trials.
Recruitment Boosts

 Companies known for innovation have an easier time recruiting and keeping talent.

 Talented researchers seek environments where they can do work that leads to important
results.

 Therefore, these researchers will seek out companies that have a developed R&D
process.

 A robust R&D program drives not only new products and devices but also entices top
talent.

 Progress comes as a result of efficient, effective teams doing the difficult work to improve
health outcomes.
How to Improve Your R&D Process?

Now that you know the importance of research and development, it’s just as important to ensure that
your R&D strategy is sound. Take the following steps to improve your R&D process:

 Set priorities that align with company-wide goals and growth strategies.

 Improve, standardize and automate processes.

 Take advantage of the wealth of data available and adopt big data strategies.

 Prioritize risk assessment across all aspects of company operations.

 Implement processes that preserve data integrity, such as electronic audit

trails.

 Pursue opportunities for strategic collaboration

References: https://www.propharmagroup.com/blog/importance-of-research-and-development/
 Chemists involved in research and development apply
their academic knowledge to real-world problems.

 They develop products that meet a specific need, while

factoring in business considerations.

 If you love scientific research and want to see a

practical application of your work, you may be well
suited for a career in research and development.

 Also required are a strong desire to create useful

products and an entrepreneurial spirit.
Typical Job Functions:

 Careers for chemists in research and development are largely found in the industrial
sector. Companies need people to develop new products and/or enhance existing
ones.

 Product development involves a blend of science and business. Coming up with an

idea for a new product is one thing; convincing a business manager and
manufacturers that it will be profitable and can be manufactured cost-effectively is
another.

 And product development timelines must be synchronized with sales and marketing
departments and with manufacturing efforts.

 Activities in the field of research and development fall broadly into two phases:
applied research and product development.
Applied Research:

• Industrial scientists modify, combine, and formulate compounds for specific uses to meet a
business goal or need.

• For example, if the business goal is to increase sales, a chemist might develop a new food with
enhanced flavor.

• But if the business needs to reduce costs, the chemist might work on developing a food with a
longer shelf life.
Job duties in research and development vary widely and depend on the industry
and the development stage of the product. Common job duties include:

 Conducting experiments to ensure the desirable features and functions of a product are
retained as other properties are changed

 Working with process engineers to “scale up” processes (i.e., make a new product in
larger quantities for commercialization)

 Filing regulatory documents

 Identifying acceptable ranges for starting materials and final products (e.g., do the
starting materials need to be 95% pure, or is 90% acceptable?)

 Reformulating existing products in response to changes in regulations or availability of

raw materials

 Using Design of Experiments methodology to learn as much as possible in the fewest

number of experiments (part of Six-Sigma training)
Career Paths
In industry, most chemists start out in research, then advance by climbing either the
research or management career ladder.

Research ladder:
Involves staying close to product development, taking on more supervisory responsibilities
and larger projects.

Management (or business) ladder:

• Involves moving away from the lab bench and into sales/marketing or
operations/production.

• Scientists in management generally have slightly more experience than those in

research, and they earn higher salaries.

• Once you move out of research and into management, it is difficult to move back to the
laboratory, as your technical knowledge and skills become outdated quickly.
Research & Development: Product development.

Product Development:

◘ Once applied research has identified a workable solution to a

specific problem, the focus shifts to developing the product.

◘ The solution is refined to produce a substance that a) is

effective, safe, and appealing, and b) can be manufactured in a
timely and cost-effective way

◘ The product development process encompasses all steps

needed to take a product from concept to market
availability.

◘ This includes identifying a market need, researching the

competitive landscape, conceptualizing a solution, developing a
product roadmap, building a minimum viable product, etc.
Research & Development: Process development:

Process development refers to the exercise of

creating a means to manufacture a given
product in a given quantity. It involves the selection
and sequencing of process steps from a repertoire
(collections) of unit operations.

Unit operations, the working tools of chemical

engineers, include such steps as mixing, heating,
cooling, pumping, size reduction and chemical or
biological reactions.

To develop a food process, one envisions all the steps

necessary to convert raw materials into finished
products and communicates this sequence in the form
of a flow diagram.

Some flow diagrams for familiar foods are shown

in Figures 6.4–6.6. These are briefly described to show
the relationship between the symbols on the flow
diagram and the operations they depict.
Research & Development: In-house failure and addressing;

What Is in-House?

◘ In-house refers to conducting an activity or operation within a company, instead of relying

on outsourcing.

◘ This occurs when a firm uses its own employees and time to keep a division or business activity, such
as financing or brokering, in-house.

◘ An in-house operation is an activity performed within the same business, using the company’s assets
and employees to perform the necessary work.

◘ This is the opposite of outsourcing, which involves hiring outside assistance, often through another
business, to perform those activities.

►https://www.investopedia.com/terms/r/randd.asp
Research & Development: Design & executions of reactions.
Production-Control and Execution:
Production Control: Ensures that manufacturing processes run smoothly and produce goods as per
specifications. Includes monitoring raw materials, optimizing process parameters, and ensuring adherence to
standard operating procedures
(SOPs).

Execution: Involves implementing planned production activities while minimizing deviations and disruptions.
Real-time data collection, equipment maintenance, and resource allocation are key components.

Testing of In-House Failure Products:

Objective: Identify the root cause of failure and develop corrective and preventive actions (CAPA).

Process:
Failure Analysis: Use analytical methods like spectroscopy, chromatography, or microscopy to investigate
physical or chemical issues.

Comparison: Analyze failed products against quality benchmarks or successful batches.

Modify formulations, raw materials, or process conditions based on findings.

Corrective Measures:
Outcome: Improve future production, minimize waste, and ensure customer satisfaction.

Importance: R&D, coupled with stringent production control and robust failure analysis, enhances the
reliability, safety, and competitiveness of products in the market.
 Types of chemistry related
industries

Commodity/basic
chemicals Specialty chemicals

Manufactured by many different

companies however the end product
is generally the same with very little They are also called
variations fine chemicals
Industry: Types of chemistry related industries; Sections and responsibilities

Sectors of Chemical Industry:

Fundamentally, the chemicals industry can be divided into two sectors;

1) commodity/basic chemicals and

2) specialty chemicals.

Commodity chemicals are manufactured by many different companies however the end
product is generally the same with very little variations. There exist other segmentations for
this industry as well. Understand the main sectors of the chemical domain.

Sales of the chemical business can be divided into the following broad
categories/sectors:

1) Basic or Commodity Chemicals - Approximately 35 to 37 percent of the dollar output

2) Life Sciences- Approximately 30 percent of the dollar output
3) Specialty Chemicals - Approximately 20 to 25 percent of the dollar output
4) Consumer Products- Approximately 10 percent of the dollar output
Basic Classification of Chemical Industry Sectors:

Fundamentally, the chemicals industry can be divided into two sectors; commodity/basic chemicals
and specialty chemicals.

► Commodity chemicals are manufactured by many different companies however the end product is
generally the same with very little variations.
► Specialty chemicals are typically made to suit the needs of a specific customer and are generally
only available from a few suppliers.

► These chemicals are often protected by patents.

Basic/Commodity Chemicals:

 They are also called basic chemicals, are typically inexpensive and include polymers, bulk
petrochemicals, basic industrial chemicals, inorganic chemicals, and fertilizers.

 Polymers make up the largest segment of this sector.

 Commodity chemicals are generally made in large volumes.

 Specialty Chemicals:

 They are also called fine chemicals; include industrial gases, adhesives, sealants, industrial cleaning
chemicals, coatings, and electronic chemicals.

 A Specialty Chemical is a chemical produced for specialized use.

 They are produced in lower volume than bulk chemicals, of which petrochemicals, made from oil
feedstock, are the most common.

 However, both are produced in a chemical plant. Some examples of specialty chemicals are
adhesives, additives, antioxidants, corrosion inhibitors, cutting fluids, dyes, lubricants, pigments, etc.

 These chemicals are generally more expensive than commodity chemicals.

 Chemicals are made from elements and every element has a unique set of physical and chemical
properties.

 Specialty chemists understand how to combine certain elements that result in a chemical with the
required properties.
 Advanced Classification of
Sectors of Chemical Industry

Science and
Life Science Technology Consumer
Chemicals Chemicals Products
Advanced Classification of Sectors of Chemical Industry:
1. Life Science Chemicals:
• These are differentiated biological and chemical substances used to induce specific outcomes in
humans, animals, plants, and other life forms.
• The major products of this segment include agrochemicals, pharmaceuticals, and biotechnology
products.
• Life sciences (about 30 percent of the dollar output of the chemistry business) include differentiated
chemical and biological substances, pharmaceuticals, diagnostics, animal health products, vitamins,
and pesticides.
• Life science products are usually produced with very high specifications and are closely scrutinized
by government agencies such as the Food and Drug Administration.
• Pesticides, also called "crop protection chemicals", are about 10 percent of this category and include
herbicides, insecticides, and fungicides.

agrochemicals pharmaceuticals biotechnology products

2. Science and Technology Chemicals:

These products include advanced materials that transform current technologies.

They enhance the characteristics of traditional specialty chemical products, as listed above.
3. Consumer Products:

Consumer products include direct product sale of chemicals such as soaps, detergents, and cosmetics.
Typical growth rates are 0.8 to 1.0 times GDP.

They include sulfuric acid, nitrogen, ethylene, oxygen, lime, ammonia, propylene, polyethylene,
chlorine, and phosphoric acid.

sulfuric acid
soaps, detergents, and cosmetics ammonia
 Sub-Segments of Chemicals
Industry
Soap & Generic
Chemical Dye &
Fertilizer Cleaning Pharmaceutic
Chemical Organic Inorganic Pesticide Product Pigment
Manufacturin Compound al
Wholesaling Chemicals Chemicals Manufacturing Manufacturin Manufacturin
g Manufacturin Manufacturin
g g
g g
Chemical Wholesaling Industry:

◘ As a key intermediary within the supply chain, the Chemical Wholesaling industry plays an
important role in overall chemical manufacturing.

◘ Because chemical wholesalers have diversified product offerings, no operator holds a dominant
share of the market.

◘ As a result, this industry is highly competitive, with wholesalers competing on storage efficiency
and distribution.

◘ This industry wholesales chemicals and related products, including compressed gas, chemical
additives, and synthetic rubber, to the manufacturing, construction, and mining industries.

◘ This industry does not wholesale agricultural and medicinal chemicals, paints and varnishes,
fireworks, or plastics materials. Major industry products are detergents and soaps, alkalies and
chlorine, industrial gases, adhesives, sealants and glues, sanitation chemicals, polishes and waxes,
synthetic rubber, dyes, and pigments.
ORGANIC CHEMICALS INDUSTRY:
 The organic chemicals industry is one of the most significant sectors of the chemical industry.
 It plays a vital developmental role by providing chemicals and intermediates as inputs to other sectors of the industry like
paints, adhesives, pharmaceuticals, dyestuffs and intermediates, leather chemicals, pesticides, etc. Methanol, acetic acid,
formaldehyde, pyridines, phenol, alkyl amines, ethyl acetate, and acetic anhydride are the major organic chemicals
produced.
 Formaldehyde and acetic acid are important methanol derivatives and are used in numerous industrial applications.
 Phenol is an aromatic compound and derived from cumene, benzene, and propylene derivatives.
 Alkylamines are used in the manufacture of surfactants.
 Pyridine derivatives are used in the manufacture of pharmaceuticals.
 Ethyl acetate is the ester of ethanol and acetic acid and is manufactured for use as a solvent.
 Acetic anhydride is widely used as a reagent. Natural gas/ naphtha are mainly used as feedstock for the manufacture of
these organic chemicals.
 Alcohol is also an important feedstock for the industry, with the sizable production of acetic acid and the entire production
of ethyl acetate being based on alcohol.
 The global production of organic chemicals was around 400 million tons during 2010-11.
 Major producers of organic chemicals are the USA, Germany, U.K, Japan, China, and India.
 Few Latin American countries, for example, Brazil and Chile are increasing their presence in the global organic chemicals
market.
INORGANIC CHEMICALS INDUSTRY:

 This industry manufactures a variety of basic inorganic chemicals.

 Inorganic chemicals are generally mineral-based.

 Most organic chemicals, on the other hand, are carbon-based. Inorganic chemicals are used as inputs

in a number of manufacturing and industrial processes.

 Key identifiable industry segments include Chlor-alkali and carbon black products. Major industry

products are Chlorine, Caustic soda, Potassium, sodium, and other alkali compounds, Chemical

catalysts, Inorganic acids, Carbon black, and Other inorganic chemicals.

Fertilizer Manufacturing Industry:
 This industry primarily manufactures fertilizer products.
 These products contain a different mixture of the three vital
nutrients essential for plant growth: nitrogen, phosphorous, and
potassium.
 The products are distributed via wholesale arrangements with
third parties or, in the case of vertically integrated operations, by
the manufacturer.
 Major industry products are phosphate fertilizers, nitrogenous
fertilizers, and mixed fertilizers.
 The major activities include manufacturing ammonia, ammonium
nitrate, ammonium sulfate, and ammonium phosphates, natural
organic and animal waste or sewage origin fertilizers, nitric acid
and phosphoric acid, nitrogenous fertilizer materials, urea,
phosphatic fertilizer materials, potting soil, plant foods, and
compost, etc.
Pesticide Manufacturing Industry:

• This industry formulates and prepares agricultural and

household pest control chemicals.
• Key products include pesticides (herbicides, insecticides, and
fungicides) and agricultural chemical products (insect
repellents, sheep dips, fly sprays, and flea powders).
• Key markets for this industry include the agricultural sector,
households, and various commercial and industrial users.

Soap & Cleaning Compound Manufacturing Industry:

• This industry produces substances that loosen and

remove soil from a surface for personal hygiene,
sanitization or cleaning clothes, linens, and
furnishings.
• The industry does not include manufacturers of
synthetic glycerin, industrial bleaches, or
shampoos.
• Major industry products include household soaps
and detergents, commercial soaps and detergents,
polishes, and other sanitation goods and surface-
active agents.
 CHEMICAL PRODUCT MANUFACTURING INDUSTRY:
• This industry manufactures a diverse range of chemical products.
• Key product groups include custom compounding plastic resins and
manufacturing toners, toner cartridges, photographic chemicals and
sensitized photographic film, paper, and plates.
• Custom compounding of plastic resins includes custom mixing and
blending of purchased plastic resins and reformulating plastic
resins from recycled plastic products.
• Major industry products include custom compounding of resins,
photographic chemicals and materials, and other related products
and preparations.
DYE & PIGMENT MANUFACTURING INDUSTRY:
• This industry manufactures synthetic organic and inorganic dyes and pigments, such as lakes and
toners (except electrostatic and photographic). As such, the industry produces various pigments and
dyes, including color, lead, chrome, metallic and zinc-based pigments as well as disperse, vat, and
direct dyes.
• A chemical intermediate product, these pigments, and
• dyes are used to impart color to numerous products.
• Major industry products include inorganic dyes
• and pigments and synthetic organic dyes and pigments.

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GENERIC PHARMACEUTICAL MANUFACTURING INDUSTRY:

 Generic pharmaceutical and medicine manufacturers develop prescription and over-the-counter drug
products that are used to prevent or treat illnesses in humans or animals.

 Generic drugs are produced and distributed without patent protection, and industry operators are not
significantly engaged in the research and development of new drugs.

 The industry does not include manufacturers of nutritional supplements or cosmetic beauty products.
Major products include pharmaceutical preparations for metabolic drugs, cardiovascular drugs,
central nervous system drugs, psychotherapeutic drugs, and other drugs.

 It includes medicinal and botanical products, in-vitro diagnostic substance products, and biological
products (except diagnostic).

 The main activities of this industry are to develop and produce drugs, market and distribute them
after gaining regulatory approval for respective drugs.

 Generic firms can be smaller because the cost of research and development is significantly lower than
it is in the brand name industry.

 Economies of scale exist when increasing the size of a company increases its productivity.