Recognition of the impacts that climate change will have on the world has driven manufacturing sectors to seek means for reducing emissions and otherwise increasing the sustainability of their operations. The pharmaceutical industry is no exception. Since the IQ Consortium’s Green Chemistry Working Group first met with the FDA in 2012 to identify opportunities for promoting green chemistry,[84] it has taken other steps to guide drug manufacturing, including the adoption of the Green Aspiration Level (GAL), originally developed by Boehringer Ingelheim[85][86] as a standardized green-efficiency goal, and development of the Green Scorecard to show the value-added impact of green chemistry and other steps, which illustrates the value-added impact of green chemistry and other steps to increase sustainability.[87]
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In the search for more sustainable small molecule manufacturing solutions, use of electrochemistry has experienced a resurgence. An added driver for their growing adoption is the potential to access molecular structures not possible using conventional organic chemistry.[89]
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Small molecule drug candidates today often have multiple chiral centers, thus many different isomers, and typically only one isomer has the desired activity, with the others potentially being harmful. Control of chirality during the manufacture of these APIs is therefore essential to ensure high yields and minimal production of unwanted isomeric impurities. Achieving such a high level of selectivity, particularly for molecules with multiple centers of chirality and potential other structural isomeric forms, is extremely challenging.
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Catalytic transformations using chemical catalysts continue to evolve. Where process chemists once had to settle for separating racemic mixtures of some chiral compounds, thus limiting the maximum yield to 50%, for many reactions today, it is possible to selectively produce one desired enantiomer. In addition, the first catalysts that enabled such transformations, which often involved rare transition metals, and sometimes toxic or hazardous ligands and reaction conditions, are increasingly being replaced with benign alternatives based on common metals, such as iron.[84]
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There are more chemocatalysts than enzymatic catalysts available for pharmaceutical manufacturing, and in some cases transitional metal or organic chemical catalysts provide better results than — or achieve transformations not possible with — the enzymes that are available. Interest in enzymatic reactions, however, continues to grow because they are often performed in water at room temperature, and do not require the use of hazardous or toxic reagents, or challenging process conditions.
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The focus on increasing efficiency while minimizing cost and waste has led many companies to look for ways to improve extraction, filtration, crystallization, chromatographic, and other widely used methods for the purification of small molecule APIs. The goal is to minimize solvent use, and decrease process times and waste, while generating higher-purity drug substances. Continuous extraction and crystallization are two approaches to reducing energy consumption and obtaining APIs of more consistent quality in a smaller footprint.
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Many complex APIs under development today suffer from poor solubility under physiological conditions (in gastrointestinal fluids) and are considered Class 2 compounds under the Biopharmaceutical Classification System (BCS). Many larger APIs with high polarity and strong crystal lattices also exhibit poor permeability through the intestinal membrane (BCS Class 4). Consequently, these drugs have posed challenges in terms of bioavailability.
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The trend toward targeted drugs and precision medicines that require lower doses and treat smaller patient populations is driving the need for small-volume API manufacturing solutions. These solutions must still be compliant with Good Manufacturing Practice (GMP) requirements, and, while they involve smaller volumes than many older small molecule APIs, there are still scale-up issues to be addressed, often for processes that involve highly specialized equipment and sophisticated technologies, such as cryogenic chemistry, advanced chromatography systems, and specialized isolation techniques, such as tangential flow filtration.80 In fact, in some cases the small batch scale may impact the choice of technologies employed for the production and purification of small-volume, small molecule APIs.
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With the percentage of HPAPI candidates growing rapidly, the issue of containment during API manufacture has come to the forefront. Containment is needed to protect workers and the environment from exposure to highly potent compounds, but also to prevent cross- contamination of HPAPIs.
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Advances in automation and sensing technology and in automation software are enabling the implementation of automation solutions by more small molecule API manufacturers. Automation of production processes provide numerous benefits, that range from greater efficiency and productivity to improved quality and safety. These benefits are realized to the greatest extent for API production processes with high operational complexity and risk.[94]
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Process intensification of small molecule manufacturing offers many benefits, including greater productivity, reduced costs, and enhanced sustainability. It generally involves the reduction of equipment size without reducing the quantity of API produced, resulting in both reduced energy and resource consumption, and in less waste production.
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Single-use (disposable) technologies are generally associated with biologics manufacturing. Their adoption for small molecule API production is increasing, however, particularly as the potency of these compounds increases and the volumes required decrease.[105] For these applications, single-use equipment offers the advantage of more flexible infrastructure combined with reduced setup and changeover times, because there is no need for CIP or steam-in-place (SIP) processes. The latter also reduces wastewater generation. Cost savings are often achieved as well.
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In recent years, interactions between academia and industry have noticeably increased. Such collaborations can be win–win relationships for both sides, particularly when they revolve around new technologies, which can range from novel API candidates to new chemical transformations. The academic institutes gain recognition and financial support, while drug makers obtain access to novel technologies that could give them a competitive advantage.
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The pharmaceutical industry is experiencing a transformative shift toward precision medicine, aiming to provide therapies tailored to individual patients' genetic and medical profiles. This paradigm shift necessitates a fundamental change in API manufacturing. Traditional batch production methods are ill-suited for the intricacies of personalized medicine. Instead, there is a growing need for highly adaptable and flexible manufacturing processes. Continuous manufacturing, which allows for real-time adjustments and precise control over drug composition, dosage, and formulation, is becoming increasingly vital. This trend extends to dosage form customization, where 3D-printing technologies are gaining traction, enabling the creation of patient-specific medications. As this trend unfolds, it holds the potential to revolutionize treatment outcomes, optimizing drug efficacy while minimizing adverse effects for individual patients.
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The need for CDMOs to offer both small-volume and large-scale manufacturing capabilities has driven growing interest in modular production solutions — self-contained manufacturing units that can be easily configured and reconfigured to produce different APIs. Not only does the use of such units afford significant flexibility in a singular manufacturing facility and the integration of advanced technologies; it facilitates reproducible production at disparate locations around the world, which is an increasing need as more national governments require at least the final stages of manufacturing for drug products marketed in their countries to take place within their own borders.
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The COVID-19 pandemic laid bare the vulnerabilities of global supply chains in pharmaceutical manufacturing. To mitigate such risks, pharmaceutical companies are reevaluating their supply chain strategies. Diversification is a key theme, with manufacturers seeking to reduce reliance on single-source suppliers and explore dual-sourcing options for critical raw materials. Furthermore, the concept of nearshoring or onshoring gained momentum, although to date there has been more discussion of onshoring that actions taken. By bringing API production closer to home markets, the industry aims to establish more resilient and agile supply chains. Redundancy is also on the rise, with companies investing in multiple production facilities and building stockpiles of essential raw materials to prevent future disruptions. These strategies collectively aim to ensure a consistent supply of APIs to meet global healthcare needs.
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Harmonizing regulatory standards is paramount for international pharmaceutical trade. Regulatory bodies worldwide, including the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH), are working tirelessly to align quality, safety, and efficacy standards. This alignment simplifies the process of obtaining approvals for new APIs, expediting drug development. It also fosters global cooperation among regulatory agencies. The pharmaceutical industry benefits from reduced duplication of efforts and faster market access. As this trend progresses, it not only streamlines the path to market but also encourages consistent quality standards across regions, ultimately benefiting patients and healthcare systems worldwide.
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With many more small, emerging, and specialty pharmaceutical companies advancing small molecule drugs to the clinic (in 2018, 65% of small molecule clinical pipeline projects were sponsored by small companies[108]), the reliance on outsourcing services continues to rise. They require support from the earliest development stages through clinical trials and commercial manufacturing. The increase in API complexity and heightened levels of potency are also driving the outsourcing of API development and manufacturing, as both small and large companies seek access to specialized skills, technologies, and equipment that is too costly for internal investment. A discussion of the small molecule API outsourcing market is presented later in this report.
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