Overview of pharmaceutical intermediate & fine chemical contract development & more on CDMO, CRO offering advanced intermediate development services.
Q1. What are pharmaceutical intermediates?
The FDA defines an intermediate as “a material produced during steps in the synthesis of an API that must undergo further molecular change or processing before it becomes an API.” Intermediates include basic intermediates and key intermediates, including bulk drug intermediates for both the pharmaceutical industry and other industries.
Pharmaceutical intermediates are fine chemicals of intermediate compounds which form the building blocks of an active pharmaceutical ingredient (API). They are used in the production of bulk drugs and also for contract research and development purposes by various pharma and biopharma companies.
Pharmaceutical intermediates are classified on the basis of product types, applications, and distribution channels. On the basis of product type, the pharmaceutical intermediates market is segmented into GMP and non GMP compounds. On the basis of application, the pharmaceutical intermediates market is segmented into antibiotics, antipyretic analgesics, vitamins, etc. And, on the basis of distribution channels, pharmaceutical intermediates are segmented into direct sales and distributors.
Active pharmaceutical ingredients (APIs) and intermediates may be confused and used interchangeably, especially by new entries in the pharmaceutical industry. Intermediates are produced when manufacturing APIs, while Active Pharmaceutical Ingredients (APIs) exhibit pharmacological activity or other direct effects in the diagnosis, treatment, symptom relief, or prevention of diseases.
Pharmaceutical intermediates are thus produced as by-products during the production of APIs or drug substances. Each reaction in the API production process produces a variety of different pharmaceutical intermediates. They can only be turned into an API by further molecular change or refinement. Furthermore, intermediates can be separated or not separated.
The rising prevalence of chronic and lifestyle-driven diseases is propelling the demand for active pharmaceutical ingredients or drug substances, thus driving the pharmaceutical intermediates market. Over the years, the adoption of good manufacturing practice (GMP) regulated-drug making activities by pharmaceutical companies has led to the rapid evolution of the pharmaceutical intermediates market.
Q2. What is the difference between fine chemicals, specialty chemicals and pharmaceutical intermediates?
Fine chemicals, specialty chemicals and pharmaceutical intermediates are separate chemical entities. The definitions of fine chemicals, specialty chemicals and intermediates are given below.
Fine Chemicals
Fine chemicals are single, pure and complex chemicals that are produced in small scale synthesis amounts by multipurpose plants. Most service providers including contract manufacturing organizations (CMOs), contract development and manufacturing organizations (CDMOs), and contract research organizations (CROs) produce chemicals in bulk using standardized reactions. Fine chemicals, on the other hand, are produced by a limited number of companies.
Pharmaceutical fine chemicals can be broadly defined as the set of products — intermediates and finished APIs, or active pharma ingredients —as well as related services like process development and optimization associated with the access of pharmaceutical companies to the drug substance (API) throughout the product life cycle excluding pre-clinical development and clinical supply.
Since small scale synthesis batches of fine chemicals are lower in quantity than batches of bulk chemicals, their production costs are higher and they also generate more waste during the manufacturing process. Ultimately, fine chemicals take the form of pharmaceutical ingredients, biocides, and specialty chemicals.
Speciality Chemicals
Most chemicals are categorized in one of two groups, commodity chemicals and specialty chemicals. Commodity chemicals are those that are produced in vast quantities, and are fairly basic and inexpensive to produce. These tend to be produced in a plant that produces enormous amounts of just one or two different chemicals.
Specialty chemicals are somewhat different, in that most specialty chemical manufacturers tend to produce them in small scale synthesis amounts. These specialty chemicals tend to be more expensive than their commodity counterparts, and are used less frequently for more specific and refined purposes.
API intermediates
As seen above an API intermediate or active pharmaceutical ingredient intermediate is a chemical compound which forms the building blocks of active pharmaceutical ingredients (APIs). Active pharma ingredients are afterwards converted into numerous forms such as capsules, tablets, suspensions etc. API intermediates are thus the compounds or agents used as raw materials for the formulation of active pharmaceutical ingredients (APIs).
Advanced Intermediates
Advanced intermediates are more advanced types of drug intermediates. Advanced intermediate drugs are generally used to carry out drug interaction activity which is developed in new chemical products.
Various contract manufacturing organizations (CMOs) and contract development and manufacturing organizations (CDMOs) offer process development, process transfer and manufacturing of fine chemicals, specialty chemicals and pharmaceutical intermediates which are then used for contract research and development (R&D), API manufacturing or other purposes.
Q3. What are some processes involved in the development and manufacturing of pharma drug intermediates?
Pharmaceutical intermediates are chemical raw materials used in the custom synthesis of APIs. Pharmaceutical intermediate products do not require a production license and can be produced in ordinary chemical plants. They are produced as a by-product during the production of APIs.
Some processes involved in the development of pharmaceutical intermediates and the manufacturing of intermediates are noted below.
Analytical Method Development
Analytical method development is the process of selecting an accurate assay procedure to determine the composition of a compound. Analytical method development for intermediates’ main purpose is to prove if any analytical method in the pharmaceutical industry is suitable to be used in the measurement of intermediates.
Process Development
Process development is used to establish, implement, or improve a pre-existing manufacturing process. It ensures that a product can be routinely made aseptically and meet specifications before manufacturing at a large scale. Process development is carried out to establish the best route of production of pharma intermediates.
Route Scouting or Route of Synthesis Scouting
Route of synthesis scouting or route scouting is used to design and demonstrate new synthetic routes or methodologies with a focus on IP, safety, cost, atom efficiency, quality and delivery to meet the goal of sustainability in the pharmaceutical industry. If a new intermediate manufacturing process is used, route of synthesis scouting or route scouting may often precede it.
Flow Chemistry
Flow chemistry or continuous flow chemistry is the process of performing chemical reactions in a tube or pipe. Reactive components are pumped together at a mixing junction and flowed down a temperature-controlled pipe or tube. This provides some major advantages such as faster and safer reactions, cleaner products, and easy scale up. Flow chemistry may be used for the contract manufacturing of intermediates.
Custom Synthesis
Custom synthesis means the exclusive synthesis of compounds on behalf of the customer, i.e., you can order a specific molecule that is only synthesized on your request on the scale, with the purity and with the specification or methods you require. Various companies offer the synthesis of APIs and intermediates or the custom synthesis of key intermediates for the pharmaceutical industry.
Scale Up and Commercialization
Scale up is the term used to refer to the increase in the batch size of a product. A pharmaceutical product such as an intermediate may scale-up multiple times throughout its life cycle to meet growing demand and requirements.
Ultimately it reaches a large enough scale for commercialization (commercial supply) to take place. Drug commercialization involves a strategic complex multi-departmental and even multi-organizational effort in collaboration to gain market access.
Various contract development and manufacturing organizations (CDMOs), contract manufacturing organizations (CMOs), etc. offer the contract development of pharmaceutical intermediates and the contract manufacturing of intermediates. Some of them are explored in detail below.
Q4. Which are the leading service providers offering fine chemicals and pharmaceutical intermediates?
Pharmaceutical intermediates are chemical compounds widely used in manufacturing various types of drugs in bulk quantities. Pharmaceutical firms such as CROs and CDMOs use drug intermediates for R&D purposes.
Service providers including contract manufacturing organizations (CMOs), contract development and manufacturing organizations (CDMOs), and contract research organizations (CROs) operate at near-full manufacturing capacity, producing a wide range of API intermediates and may offer fully customized end-to-end services for clinical and commercial production of intermediates using various synthetic technologies.
Some leading companies offering the manufacturing and contract development of pharmaceutical intermediates and fine chemicals are noted below.
Minakem - Fine Chemical / Intermediate Development
Minakem is a manufacturer of fine chemicals, pharmaceutical intermediates and active pharma ingredients. It has roots of more than 65 years and functions as a CDMO for APIs and intermediates. It provides contract development of pharmaceutical intermediates and drug substances including HPAPIs.
Minakem offers a combination of innovative development and manufacturing solutions through a wide range of flexible assets, specialized synthetic technologies and advanced process capabilities (process transfer and process development) for the custom synthesis of key intermediates, active pharmaceutical ingredients (APIs), commercial APIs and HPAPIs at all production scales including clinical supply.
PMC Isochem - Custom Development of APIs and Intermediates
PMC Isochem offers custom development and manufacturing of cGMP intermediates, active pharmaceutical ingredients (APIs), excipients and polymers for drug delivery solutions. It therefore functions as a CDMO for APIs and intermediates.
PMC Isochem offers fully customized end-to-end services for fine chemical intermediates (cGMP or non cGMP) for clinical and commercial production. Their products are based on key synthetic technologies and advanced chemistry for the synthesis of APIs and intermediates.
Pfizer CentreOne - Custom Development of APIs and Intermediates
Pfizer CentreOne, a global contract development and manufacturing organization (CDMO) offers development and manufacturing of intermediates, specialty APIs, small molecule APIs, commercial APIs, large molecule biologics, etc.
Its Kalamazoo facility produces APIs and intermediates that Pfizer uses for its own branded medicines. Pfizer CentreOne therefore functions as a CDMO for APIs and intermediates. It offers the contract development of intermediates and drug substances.
Eurofins CDMO - Contract Research and Development of APIs and Intermediates
Eurofins CDMO offers process research and process development (PR&D) expertise in the R&D and custom synthesis of key intermediates, starting materials, impurities and reference standards, and the scale up and synthesis of APIs and intermediates including synthetic route design / route scouting.
It also offers stability studies for raw materials, intermediates, APIs, etc. It thus functions as a CDMO for APIs and intermediates and offers commercial APIs for clinical supply and commercial supply.
UQUIFA - Advanced Intermediate Development
UQUIFA is a manufacturer of Active Pharmaceutical Ingredients (APIs) and intermediates for the pharmaceutical and animal health industries globally. It is a leading company for API and advanced intermediate development and manufacturing.
It can offer fully customized end-to-end services from R&D, process transfer, contract development of intermediates and drug substances to cGMP compliant manufacturing across two continents, America and Europe. Thus, it functions as a CDMO for APIs and intermediates for clinical and commercial production (commercial supply).
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Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients & provides custom-made solutions.
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PMC Isochem is your partner for smart CDMOs of Intermediates, APIs, & excipients & a catalog of Intermediates & Generic APIs.
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Valsynthese, part of the SSE Group, is a CDMO focused on highly energetic and highly hazardous chemistry.
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Aarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.
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Olpha, a JSC AB City subsidiary, is a leading Baltic firm with 50 years of experience in medicines & chemical pharmaceuticals.
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M2i Group, an integrated CDMO, is your French partner for development & manufacturing in fine chemistry.
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Farmhispania Group, a leading European CDMO in HPAPI Technologies & High Potency Fermentation.
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Porton Pharma Solutions: Value creation via innovation & discovery through technical platforms.
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Pfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.
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Bioquim: An European GMP-certified company manufacturing bulk APIs, specializing in sterile lyophilization and chemical synthesis.
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Allsino Pharma excels in R&D & manufacturing of RSMs, GMP intermediates, & APIs; ISO-certified, GMP-compliant, accredited by NMPA.
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TAPI offers customized CDMO Solutions for API development and manufacturing services.
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