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    Overview of process development & optimization of APIs & small molecules from route selection & scale up to commercialization, by CDMOs and CMOs.

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    Overview of process development & optimization of APIs & small molecules from route selection & scale up to commercialization, by CDMOs and CMOs.

    Q1. What is API process development?

    Process development is the strategy via which a manufacturing process is identified for a drug substance from an early stage through scale-up and tech transfer to commercialization. Process development is carried out by process developers who work closely with process engineers and technology transfer teams to define suitable drug manufacturing routes in order to ensure seamless production, from milligrams to kilograms. 

    Generally, process development studies provide the basis for process improvement, process validation, continuous process optimization, and any process control requirements. They anticipate and identify development and manufacturing steps which could affect the quality of the product, in order to control these variables during large scale custom API production. 

    As drug development begins with API development and manufacturing itself, it is well worth considering the level of small to large scale custom API capabilities required for the substance of interest and outlining the goals for the API manufacturing and development project. A CDMO for API process development works with large and small molecule APIs as well as niche APIs.

    Contract development and manufacturing organizations or a CDMO for API development provide such pharmaceutical API CDMO services including, but not limited to, advanced process development, scale up, analytical development, process safety assessment, and route development. Process development routes can differ from one CDMO for API development to another as it depends on variables like the quality of raw materials, target protein stability, purification strategies, downstream yields, scale, etc.

    API process development is the work that leads to the efficient, reproducible, economical, safe and environmentally friendly API manufacturing and development in a regulated environment. During API process development special attention is paid to the chemical synthesis routes chosen for the drug substance.

     

    API process development involves:

    -  Route development and process safety assessment

    -  Development of new, scalable API route options

    -  cGMP Starting Material assessment

    -  Starting material and other raw materials sourcing and development

    -  Polymorph screening & salt selection

    -  Analytical method screening and preliminary stability profile

    -  Pre-formulation and preclinical supply

     

    API process development is a crucial step in drug manufacturing for the following reasons:

    -  Optimization of expression level and cell culture suitability for entering downstream processing

    -  Purification of the target protein

    -  Ensuring target protein stability through processing

    -  Design for process robustness

    -  Process meets criteria for process yields and cost of goods sold

    -  Ensuring an acceptable drug substance storage time

    -  Provide the correct drug substance composition

    -  Design for process scale-up

    Q2. What are the different pharmaceutical API CDMO services from process development to commercialization?

    CDMOs for API development with small to large scale custom API capabilities provide a range of pharmaceutical API CDMO services which enable API development and manufacturing. These pharmaceutical API CDMO services, from early phase development to commercialization, are explored below: 

    Step 1: Physicochemical Studies

    In this stage of API development & manufacturing , the physicochemical properties of a drug substance are characterized and established. Every drug substance has intrinsic chemical and physical properties which need to be considered before API manufacturing & development can be conducted at a larger scale.

    Therefore, physicochemical studies provide relevant information for formulation selection for later stages of clinical development and commercial contract manufacturing. Physicochemical studies further anticipate the need for molecular modifications.

     

    Route Development & Route Optimization:

    Synthetic route development or route scouting is an analytical development service carried out during the early stages of drug development that offers significant benefits by decreasing processing times, improving quality and safety profiles (via process safety assessments), reducing chemical waste production, and improving scalability. Route development further helps in identifying small to large scale custom API capabilities and custom synthesis technologies required to successfully carry out API production.

    Furthermore, route development leads to route optimization. Route optimization can reduce costs, increase the efficiency of drug substance development processes, increase the safety of drug products, and accelerate the drug substance development and manufacturing process altogether. Route development and route optimization can be achieved by outsourcing API production to well equipped CDMOs for API process development.

     

    Step 2: Reactor Treatment

    API starting materials, selected during the early stages of analytical development, are treated in reactors with custom synthesis technologies to obtain the required intermediates.

    Step 3: Purification

    Intermediates are purified to obtain individual drug products via sedimentation, filtration, centrifugation, etc. Purification is an important step of API development as removing impurities without detrimentally affecting API yield is important. CDMOs for API development possess small to large scale custom API capabilities including reactor treatments and purification.

    Step 4: Scale up

    Scale up is generally defined as the process of increasing batch sizes. In process scale up, a formula is transformed into a viable, robust product by the development of a reliable and practical method of manufacturing that affects the orderly transition from laboratory to routine processing in a full-scale production CDMO facility. Scale up is further supported by technology transfer services.

    Commercialization

    The development of drug substances via contract manufacturing services, are usually followed by packaging selection, late stage analytical development services, and finally commercialization. Product commercialization processes involve complex multi-departmental (and often multi-organizational) collaboration to establish market access, patient and provider awareness, sales force readiness, customer support programs, supply chain preparedness, and more. CDMOs for API development may support commercialization activities by offering regulatory support and other services.

    Q3. When does it make sense to use a CDMO for API development?

    Before commencing the API development and manufacturing steps outlined above an organization needs to decide whether they will produce APIs or drug substances in house or engage in outsourcing their production activities to contract development and manufacturing organizations or CDMOs for API process development and manufacture. 

    A pharmaceutical contract development and manufacturing organization or a CDMO, is a company which specializes in providing CDMO services ranging from drug substance development & manufacturing to pharmaceutical packaging services including pharmaceutical serialization and aggregation, with complete trust and transparency.

    Outsourcing API and finished pharmaceutical drug product manufacturing to CDMOs has gained traction in the past few years. The decision to develop and manufacture in-house is becoming an exception as the complexity of drug candidates rises and cost pressures increase. Many pharma firms are turning to CDMOs to reduce capital investment and gain valuable specialized expertise without having to hire expensive, highly specialized scientists and other professionals.

    With a CDMO for API process development and manufacture, sponsors get access to advanced process development services, custom synthesis technologies, equipment and facilities that would be hard to justify purchasing for isolated projects. Furthermore, CDMOs practice regulated GMP API manufacturing and development which ensures the production of high quality APIs with reduced risks of contamination and impurities. 

     

    The following situations, amongst various others, warrant outsourcing a part or the entirety of ones’ manufacturing process to a CDMO:

    -  Companies that want to focus on late stage activities such as marketing their product.

    -  Companies that want extensive process safety assessments to ensure safety of drug products for clinical development.

    -  Companies looking to reduce costs of production such as investing in costly custom synthesis technologies and qualified personnel.

    -  Companies looking to accelerate the time to market their products.

    -  Companies that want external regulatory support.

    -  Companies that want access to advanced process development and planning services.

    -  Start-ups with limited resources and capabilities.

    Q4. What is the role of putting “D” in CDMO with advanced process development?

    Organizations enabling the outsourcing of diverse activities associated with the pharmaceutical supply chain include CROs, CMOs, and CDMOs.

    - Contract Research Organization (CRO): These organizations support preformulation development and lack expertise in scale up, technology transfer, and commercialization activities.

    - Contract Manufacturing Organization (CMO): These organizations focus on large scale manufacturing activities leading to commercialization, and may provide preformulation services. However, their focus is more heavily centered around manufacturing and less on early stage development. 

    - Contract Development and Manufacturing Organization (CDMO): These organizations are fully equipped to handle a project from early phase discovery and development to late stage bulk manufacturing and commercialization activities. 

    Contract manufacturing organizations that engage in development activities like analytical development, early phase development, and advanced process development add “D” in their names to distinguish themselves from organizations solely focused on manufacturing activities (CMOs). 

    While CMOs have been around for longer, more and more organizations are attempting to expand the services they offer and transition into full service, end-to-end CDMOs as outsourcing the entire development and manufacturing process with support along each step is more appealing to partnering customers.

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    Interquim SA

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    Interquim's R&D team has extensive experience in the field of developing chemical processes & purifying APIs. Its new synthesis laboratories are fitted with state-of-the-art technology for process development.

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    Minakem provides fully integrated and technology-oriented contract manufacturing services ranging from process development, kilo lab and pilot scale-up through to full industrial scale manufacturing of complex molecules including highly potent APIs.

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    Evonik is a global CMO leader in API process development and upscaling. It offers process development and manufacturing of small-molecule APIs and fermentation-based products.

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    Inabata's Pharmasynthese has a research and development laboratory which offers a variety of services, such as new molecule synthesis, process development, process industrialization and scale-up, process optimization and troubleshooting, etc.

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          Robinson Brothers is one of the UK's largest independent manufacturers of speciality organic chemicals. We are capable of handling Amination, Bromination, Dehydrogenation, Thiolation, Esterification, Heterocyclic Chemistry etc.

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          ScinoPharm can develop new synthetic routes from the beginning or modify and optimize processes provided by customers. We can provide gram quantity material for biological testing as well as high kilogram volumes of cGMP material for clinical trials.

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          Kekule Pharma provides various services including custom manufacturing and process development, API contract manufacturing, impurity synthesis, scale up studies, commercial manufacture of APIs in cGMP facilities, regulatory documentation, etc.

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            PROCESS OPTIMIZATION FOR PRODUCTION OF INTERMEDIATES

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            CTX Life Sciences has a large intermediate plant capable of handling complex reactions and has the capability of manufacturing as per customer requirements.

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            Arevipharma

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            LAB CAPACITIES FOR PROCESS DEVELOPMENT & SCALE-UP

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            Multi-Purpose Plant for highly active compounds Capacities Lab capacities for process development and scale-up

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            Shanghai Chemspec Corporation

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            PROCESS DEVELOPMENT IN GMP KILO LAB & GMP PILOT PLANT

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            Chemspec conducts research studies for pharmaceutical chemicals, including custom synthesis and process development of pharmaceutical intermediates and APIs and also research studies for liquid crystal.

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            ZCL Chemicals Limited

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            PROCESS DEVELOPMENT

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            Our highly qualified professionals are working in product development, analytical development & IP rights. Our activities include route scouting, process development, scale up, technology transfer, synthesizing impurities, contract research, etc.

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            Pharma Service: API Manufacturing

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            Angelini Pharma

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            PROCESS DEVELOPMENT & OPTIMIZATION

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            Angelini has custom development and manufacturing capabilities including process development and optimization (early to late stage, small to large scale), manufacturing pilot, pre-validation, validation and commercial batches, ICH stability studies, etc.

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            Recipharm AB

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            API PROCESS DEVELOPMENT

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            Recipharm has extensive knowledge of process development and many years of hands-on experience of small to medium-scale manufacturing of APIs. 

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            Menadiona

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            PROCESS DEVELOPMENT & OPTIMIZATION

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            Menadiona offers contract development & full contract manufacturing services for APIs, advanced intermediates, starting materials and industrial products. They also deliver cost-efficient synthesis, process development & life-cycle management solutions.

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            KriSan Biotech

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              PROCESS DEVELOPMENT AND ROUTE OPTIMIZATION

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              KriSan Biotech's core competencies include process development and synthetic route optimization, thereby providing services to redesign an entire route for one of its potential products or key intermediates.

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              Maithili Life Sciences

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                OPTIMIZATION OF REACTION CONDITIONS

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                Optimization of reaction conditions to reduce manufacturing costs by classical methods or statistical design of experiments (DOE).

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                CLEARSYNTH LABS LIMITED

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                  PROCESS DEVELOPMENT-OPTIMIZE PROCESSES

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                  Delivery of a drug candidate from the discovery stage to clinical phases requires a robust and well-defined process research and development plan.

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                  Curia

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                  PROCESS DEVELOPMENT

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                  Curia's state-of-the-art laboratories are equipped with the latest process and analytical instrumentation to conduct rapid process development, route scouting, optimization of reaction conditions for scale-up of materials for preclinical trials.

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                  Piramal Pharma Solutions

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                  API PROCESS DEVELOPMENT SERVICES

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                  Piramal has been providing pharmaceutical intermediate and API process development services for nearly three decades from its network of R&D and manufacturing facilities across the globe.

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                  Siegfried AG

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                  PROCESS OPTIMIZATION

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                  Siegfried’s chemical expertise centers on the development and production of active pharmaceutical ingredients and intermediates, thus making Siegfried the ideal partner for both cGMP and non-cGMP active pharmaceutical ingredients and intermediates.

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                  Onyx Scientific

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                    PROCESS RESEARCH & DEVELOPMENT

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                    Onyx Scientific delivers process research & development services (process R&D) for your small molecule API to meet specific requirements. Its early-phase work consists of the production of robust process outlines, stress testing, impurity tracking, etc.

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                    TopChem Pharmaceuticals

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                    API PROCESS DEVELOPMENT

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                    The evolution of the chemical synthesis and scale up of an API from lab to plant scale is a complex process, which is specialised & intensive. TopChem offers customers the option of outsourcing the development and optimisation of their process technology.

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                    GGC Chemicals and Pharmaceuticals

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                      PROCESS DEVELOPMENT & OPTIMIZATION

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                      GGC Chemicals offers chemistry and manufacturing services for process research, process development, and scale-up manufacturing. It also provides process optimization solutions to optimize defined sets of parameters while adhering to constraints.

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                      Huvepharma Italia S.r.l

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                        API MANUFACTURING PROCESS OPTIMIZATION

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                        Huvepharma® Italia is a recognized as a reliable supplier of development and manufacturing services of APIs & advanced intermediates for leaders in the international market.

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                        SIMS Srl

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                        PROCESS DEVELOPMENT FOR NCEs / APIs

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                        Our mission is Process development for NCEs, existing APIs or advanced intermediates with feasibility, Periodic re-evaluation and improvements of existing processes, CUSTOM services and preparation of samples and impurities.

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                        Concord Biotech

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                        PROCESS DEVELOPMENT & OPTIMIZATION

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                        As part of CRMO, the Chemical R&D provides the Development of Downstream process for upstream process, Process optimization and scale up of processes from R&D to pilot and commercial, Continuous process improvement to improve the overall process yield

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                        CARBOGEN AMCIS AG

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                        DRUG DEVELOPMENT & COMMERCIALIZATION SERVICES

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                        Carbogen Amcis SAS is a leading service provider, offering a portfolio of drug development and commercialization services to the pharmaceutical and biopharmaceutical industries at all stages of drug development.

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                        ChemGenix Laboratories Pvt Ltd

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                          CHEMICAL PROCESS DEVELOPMENT

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                          ChemGenix's state-of-the-art lab facility provides different Chemical Process development options for product development to our Customers and Associates.

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                          Servier

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                          PROCESS DEVELOPMENT & VALIDATION

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                          Servier CDMO offers a full range of contract development and manufacturing services, from concept and product development to analytical testing, commercial scale and regulatory approval.

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                          Dalton Pharma Services

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                            OPTIMIZATION OF EXISTING SYNTHETIC ROUTES

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                            Dalton Pharma Services is an ideal contract partner for your API Process Development. We are FDA registered and Health Canada approved, and provide integrated process development, API manufacturing and finished dose manufacturing at a single location.

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                            Grace

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                              PROCESS DEVELOPMENT, OPTIMIZATION & RESEARCH

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                              Grace Albany Fine Chemicals' site is designed to meet customers' highest quality, regulatory, and confidentiality expectations for the manufacture of fine chemicals and intermediates.

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                              Solvias

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                              PROCESS RESEARCH AND DEVELOPMENT

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                              Solvias offers manufacturing and development expertise including process research and development, API synthesis up to multi kg scale under GMP or non GMP.

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                              Dalton Pharma Services

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                                PROCESS PARAMETERIZATION & OPTIMIZATION

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                                Statistical Design of Experiments (DoE) for process parameterization and optimization

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                                Aragen Life Sciences

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                                PROCESS RESEARCH, DEVELOPMENT & OPTIMIZATION

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                                GVK BIO offers research and development of synthetic pathways for the production of even the most complex molecules and multi-step synthesis pathways.

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                                Siegfried AG

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                                PROCESS OPTIMIZATION & IMPROVEMENT

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                                Siegfried offers a broad base of know-how in complex oral and sterile formulations of drug products available for custom development and manufacturing (CDMO), and licensing.

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