How advanced technologies are unlocking the future of drug manufacturing

Published: 26-Mar-2024

As the drug production landscape changes, it opens the door to pursue hybrid opportunities that push the boundaries of technological advancement in the field, reports  Jon Brice, Senior Vice President of Business Development at Asymchem

As an industry leader in the two key domains of flow chemistry and biocatalysis, Asymchem has developed an innovative manufacturing approach that synergises both: flow biocatalysis.

By doing so, the company offers a compelling alternative to traditional solid-phase chemical methodologies for more complex architectures, such as peptides and oligonucleotides. 

Proactive sustainability and risk mitigation

Finding the right partner for flow chemistry and biocatalysis solutions helps drug manufacturers to address both sustainable and chemical technology aspects of pharmaceutical projects and enable them to benefit from

  • higher quality
  • access to novel chemical structures
  • novel transformations or reactions that are not practical to implement at large scale in batch mode
  • increased resources, time and reduced cost savings.

Traditional 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.

By contrast, Asymchem has developed a scientific mechanism to evaluate safety risks that is diligently implemented as processes move from benchtop experimentation to progressively larger scales. 

A reliable non-GMP sourcing strategy and regulatory compliance

How advanced technologies are unlocking the future of drug manufacturing

Navigating the landscape of non-GMP manufacturing is considerably more exclusive and poses unique challenges when conducting due diligence.

There is an inherent risk associated with non-GMP supply chains as it is not uncommon for such companies to face sudden closures owing to bankruptcy or manufacturing incidents.

Consequently, emphasising risk mitigation in the context of non-GMP materials cannot be overstated. Solutions such as Asymchem’s “make versus buy” analyses enable distinctions to be made between raw materials that are 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. 

The fundamental measure of compliance lies in adhering to GMP requirements. The extent to which a CDMO rigorously implements its quality system serves as the litmus test, which is often best manifested with an extensive track record of outstanding regulatory performance.

Most CDMOs are focused on medicinal chemistry, prioritising the swift synthesis of compounds for early stage studies with scant attention to process efficiency and sustainability.

In stark contrast, acting as a process R&D and manufacturing company enables the acquisition of Big Pharma clients right from inception.

Working with a trusted CDMO for innovation and acceleration

One of the reasons that Asymchem is so focused on technology is that technology is borderless. In its capacity as a CDMO, Asymchem delivers tangible drug substances to complement the pursuit of cutting-edge technology that fosters the generation of invaluable knowledge.

The true essence of Asymchem that crafts these assets and serves as the cornerstone of its offerings starts in China. Key differentiators of Asymchem’s flow biocatalysis for manufacturing include

  • a profound commitment to environmental risk management, such as working exclusively with materials that can be disposed of responsibly
  • the meticulous selection of prospective vendors for non-GMP manufacturing, while also qualifying themselves as a supplier for unexpected disruptions
  • the constant generation of novel opportunities for innovation and enhancement — prospects that might elude those with less advanced capabilities.

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