January 29, 2024 PAO-03-24-CL-04
One effective strategy for a CDMO to distinguish itself from competitors is by cultivating expertise in innovative manufacturing technologies. The establishment of a distinctive technology portfolio opens up possibilities across various application domains. Take synthetic biology, for example, which can be harnessed for diverse industrial purposes, such as carbon capture, eco-friendly synthesis of sustainable dyes, and microbial wastewater treatment. Proficiency gained in these unique domains can subsequently serve as a source of fresh concepts and a pathway to enhance and optimize the efficiency of pharmaceutical manufacturing. Moreover, possessing proficiency across a spectrum of advanced technologies creates opportunities for new synergies that would otherwise remain untapped without a comprehensive understanding of these multifaceted novel capabilities.
Asymchem has dedicated itself to serving the pharmaceutical industry by cultivating an extensive portfolio of cutting-edge technologies over many years. The company’s very robust technology ecosystem comprises several advanced technical manufacturing solutions in which Asymchem has developed a high level of expertise.
Notably, the company stands as an industry leader in two key domains: flow chemistry and biocatalysis. The in-depth knowledge and expertise of these technologies have led to the development of an innovative manufacturing approach that synergizes both: flow biocatalysis. This novel approach, resulting from the synthesis of flow chemistry and biocatalysis, stands as a distinctive offering now accessible to Asymchem's customers. This example underscores Asymchem's commitment to pursuing hybrid opportunities and pushing the boundaries of technological advancement in the field.
The full potential of flow biocatalysis is not yet known, as this new solution has only arisen in the last 12 to 18 months. Also in the last year, Asymchem began leveraging biocatalysis to produce more complex architectures, including peptides and oligonucleotides, offering a compelling alternative to traditional solid-phase chemical methodologies. With biocatalysis, the integration of fragments occurs seamlessly within the liquid phase, introducing strategic control points from a regulatory perspective and facilitating the purification of intermediates.
Innovation remains at the core of Asymchem's identity, serving as a true differentiator for the company. Asymchem’s unwavering commitment to innovation is driven by the overarching goal of delivering superior solutions to our clients as they navigate the journey from preclinical development to commercialization. Every investment in new technologies at Asymchem is deliberately geared toward the creation of practical solutions that are designed to apply seamlessly across laboratory settings, pilot plants, and clinical and commercial production facilities.
The discourse surrounding green chemistry and sustainability within the pharmaceutical industry has transitioned from aspirational to imperative. CDMOs face mounting pressure to demonstrate their capacity to implement environmentally-friendly processes, aligning with their clients' corporate sustainability objectives.
Asymchem stands as a shining example, uniquely poised to provide pharmaceutical developers with sustainable solutions. The company's two flagship technologies, flow chemistry and biocatalysis, are inherently greener and more sustainable than traditional, resource-intensive, stepwise batch organic chemistry. Asymchem's prowess in developing scalable solutions, from laboratory experiments to full-scale commercial production, positions it as a potential industry leader in providing authentic sustainability efforts on behalf of customers.
It also merits mention that these two cutting-edge technologies not only facilitate greener drug manufacturing but also offer a host of additional advantages over their conventional counterparts. Indeed, Asymchem has pursued expertise in both flow chemistry and biocatalysis because these technologies offer significant benefits compared with historic technologies, including higher quality; access to novel chemical structures; performance of novel transformations or reactions not practical to implement at large scale in batch mode; and resource, time, and cost savings. As such, Asymchem's profound expertise in flow chemistry, biocatalysis, and the emerging domain of flow biocatalysis enables the company to deliver unparalleled value to clients, addressing both sustainability and chemical technology aspects of their pharmaceutical projects.
Chemical manufacturing, whether geared toward drug substances, cosmetics, lubricants, or other products, invariably entails hazards that demand meticulous management to safeguard employee health and safety. Companies that ardently pursue novel technology development inherently acquire substantial engineering prowess.
For Asymchem, the extension of this engineering expertise to the realm of safety solutions was a natural progression. As such, safety engineering has evolved into a central competency of Asymchem, systematically applied throughout all facets of its operations, spanning from synthesis reactions to purification processes.
Notably, Asymchem has developed a scientific mechanism for evaluating safety risks, diligently implemented as processes move from laboratory-scale experimentation to progressively larger scales. These assessments are performed within cutting-edge, specialized non-GMP workspaces and facilities, encompassing every operational phase, including the use of raw materials procured by Asymchem.
With a focus on environmental risk management, Asymchem exclusively works with materials that can be disposed of responsibly. The company has also made substantial investments in state-of-the-art waste treatment and remediation technologies, solidifying its commitment to environmental stewardship. As a reflection of that commitment, Asymchem was the sole enterprise in its vicinity permitted to continue operations during the 2008 Beijing Olympics.
While the pharmaceutical industry typically associates its greatest risks and quality concerns with noncompliance with Good Manufacturing Practice (GMP) requirements, there exists a widespread misconception. Thousands of companies offer GMP-compliant chemistry services, making it relatively accessible. In stark contrast, the landscape for non-GMP manufacturing is considerably more exclusive and poses unique challenges in conducting due diligence. Furthermore, it is not uncommon for such non-GMP-focused companies to face sudden closures due to bankruptcy or manufacturing incidents. Consequently, emphasizing risk mitigation in the context of non-GMP materials cannot be overemphasized.
Asymchem has meticulously devised a set of due diligence exercises to scrutinize prospective vendors. The company also conducts "make versus buy'"analyses to distinguish between raw materials suitable for procurement and those better suited for in-house manufacturing. This determination hinges on multiple factors, including the number of suppliers, the extent of familiarity Asymchem has with these suppliers, and their reputation for being high-quality and dependable.
Crucially, even in instances where the decision leans toward purchasing a non-GMP raw material, Asymchem takes an innovative approach by qualifying itself as a supplier. This strategic foresight ensures that Asymchem can step in to produce the material should the supply become unexpectedly disrupted, for any reason. This approach holds immense benefits for clients as these raw materials form the foundation upon which entire chemical synthesis pathways rest. They also represent a substantial proportion of the overall chemistry operations. Asymchem's commitment to this strategy effectively shields its clients from the inherent risks associated with non-GMP supply chains.
While CDMOs offering API synthesis services may seemingly share similar chemistry fundamentals, they encounter a unique challenge when distinguishing themselves in a competitive landscape. Chemistry, in essence, follows well-established principles — transformations that involve carbon–carbon bond formation, functional group oxidation or reduction, and more. Despite continuous reports in the academic literature detailing innovative transformation methods, the practical applicability of these methods in commercial pharmaceutical intermediate and drug substance manufacturing often remains limited and poorly understood.
Once again, the differentiator is how those transformations are implemented using novel technologies. Transitioning from traditional batch-based processes like alkyl lithium and organomagnesium chemistry, which necessitate cryogenic temperatures, result in significant energy consumption, elevated carbon dioxide emissions, and substantial costs. In contrast, the adoption of flow-chemistry processes reduces costs and carbon footprint, enhances safety, and frequently improves product yield and purity. Despite the same transformation at its core, the utilization of a superior technological approach unlocks more value from the chemistry.
Harnessing the power of biocatalysis and flow chemistry, Asymchem epitomizes this paradigm shift. Furthermore, the company's mastery of these technologies, bolstered by profound knowledge and extensive experience across diverse applications, constantly generates novel opportunities for innovation and enhancement — opportunities that might elude those with less advanced capabilities.
Consequently, Asymchem has transcended its identity as a traditional CDMO and emerged as a prominent force in developing manufacturing technologies. The company has undertaken the formidable task of bringing the value of flow chemistry to pharmaceutical manufacturing, including the handling of solids, salts, emulsions, suspensions, and more. Continuously shouldering the burden for its clients, Asymchem facilitates their access to the advantages of cutting-edge technologies without requiring exorbitant investments in time, resources, or finances.
For pharmaceutical CDMOs, a demonstrated track record of regulatory compliance coupled with a proven quality system is absolutely paramount. This importance becomes even more pronounced for CDMOs situated in emerging market geographies, given the skepticism stemming from numerous public failures.
Creating an effective quality assurance system that can convincingly demonstrate a CDMO’s unwavering commitment to quality assurance requires substantial effort, resources, and a culture of continual improvement. In some respects, it can be likened to possessing an additional technology.
The fundamental measure of compliance lies in adhering to GMP requirements. A CDMO is either compliant or not, a distinction readily unveiled during audits. The extent to which a CDMO rigorously implements its quality system serves as the litmus test, often best manifested through an extensive track record of outstanding regulatory performance.
Asymchem stands apart from its counterparts in China. Most other CDMOs in the country initially focused on medicinal chemistry, prioritizing the swift synthesis of compounds for early-stage studies with scant attention to process efficiency and sustainability.
In stark contrast, Asymchem's genesis as a process R&D and manufacturing company allowed it to serve big pharma clients right from its inception. Consequently, the company operated under rigorous standards pertaining to environment, health, and safety (EHS), site engineering, documentation, and other aspects — a mindset that set it apart.
Over time, Asymchem's clients have evolved alongside the company, with projects transitioning from early development to full-scale commercial production. This process of nurturing client relationships has significantly contributed to Asymchem's robust track record of performance. In fact, the company's audit history reflects the substantial efforts, resources, and diligence invested in crafting a sturdy regulatory framework — a framework that instills confidence in Asymchem's clients and makes them feel secure in their partnership with the company.
One of the reasons that Asymchem is so focused on technology is that technology is borderless.
The pursuit of cutting-edge technology not only yields tangible assets but also fosters the generation of invaluable knowledge. In its capacity as a CDMO, Asymchem delivers tangible drug substances — physical assets that underpin pharmaceutical development. However, the true essence lies in the processes harnessed by Asymchem to craft these assets, serving as the cornerstone of its offerings. These processes can be conceived and perfected in China, with the knowledge easily transmitted electronically to sites located anywhere in the world for seamless implementation.
This technological proficiency empowers Asymchem to undertake endeavors that many other CDMOs are simply incapable of. Fifteen years ago, collaborating with Chinese CDMOs bore fruit primarily through cost savings relative to their U.S. and European counterparts. However, the landscape has evolved, and today, the price differentials have dwindled significantly.
What sets Asymchem apart now is the sheer depth of its unique capabilities, a distinction that transcends geographical boundaries. The company has wholeheartedly embraced technology, a departure from the conventional practices within the CDMO industry. Indeed, Asymchem's primary selling point and genuine differentiator lie in its prowess in manufacturing technology.
Dr. Jon Brice brings over 25 years of experience to the chemical pharmaceutical development and manufacturing industry. He earned his B.S. in chemistry from Reed College followed by his Ph.D. in organic chemistry from the University of Illinois Urbana-Champaign. In Dr. Brice’s early career, he held various analytical chemist roles at Abbott Labs, Bayer, and Amgen. He began his career in business development at Norac and joined Asymchem in 2008. In his current role as Senior Vice President of Business Development, Dr. Brice has developed Asymchem’s commercial business with many of the world’s top pharmaceutical companies. His in-depth technical knowledge of chemical manufacturing combined with his understanding of the business has contributed to nearly half of the company’s growth over the past 10 years.
.svg)