Susan Li holds a PhD in Polymer Chemistry and Physics from Nankai University and was a postdoctoral fellow at the University of Texas Southwestern Medical Center. She previously held key roles at PolyPeptide Group, Stanford Research Institute, and Sinopep, focusing on peptide APIs and therapeutics. She now serves as Peptide Chief Scientist at Asymchem, overseeing peptide CMC development and manufacturing
As a comprehensive TIDES solution provider, how does Asymchem’s integrated platform create distinct value for clients navigating today’s complex development and supply chain challenges?
Asymchem’s distinct value lies in its deeply integrated end-to-end partnership model which moves beyond fragmented services to offer full accountability from discovery through commercialization. This is critical as sponsors increasingly seek partners who can streamline development complexity and ensure continuity quality and speed throughout the molecule’s lifecycle. Our approach combines dedicated peptide and oligonucleotide platforms with specialized teams capable of designing robust processes for even the most complicated sequences. Furthermore, we secure reliable raw material supply integrating supply chain management directly into our service offering. This covers not only synthesis through to commercial production but also ensures the stability and quality of critical materials like monomers and amino acids mitigating risks associated with today’s fragile global supply chains.
How do process innovations like TAG-assisted synthesis and continuous purification specifically enhance scalability and sustainability in peptide manufacturing compared to traditional methods?
Process innovations like the TAG-assisted liquid-phase tides synthesis directly overcome the scalability limitations of traditional solid-phase synthesis. This is complemented by continuous purification MCSGP which breaks the bottleneck of traditional batch chromatography. The integrated approach enables scalable output while maintaining critical quality attributes. Crucially this system significantly reduces solvent consumption and improves Process Mass Intensity aligning scalability directly with sustainability goals. Advanced techniques like spray drying and precipitation further replace traditional inefficient lyophilization creating a more efficient and environmentally responsible manufacturing process.
In what concrete ways are digital tools and AI fundamentally improving control and outcomes in TIDES production?
Digital tools and automation are core to making TIDES manufacturing more reproducible, faster and safer. Process Analytical Technology (PAT) provides real-time feedback and enables continuous flow chemistry making these advanced processes possible while ensuring product quality and yield. Furthermore AI-enabled data feedback loops are used to identify impurities during synthesis. This data is fed back to synthesis teams enabling them to improve processing procedures to eliminate or decrease impurities early on. Managing impurities at this stage reduces pressure on downstream processing, improves final product yield and decreases resource consumption during late-stage or commercial phases.
Enzymatic ligation is emphasized as a greener alternative to traditional synthesis. What advantages have you observed in terms of yield, purity, and environmental impact?
Enzymatic ligation is recognized as a key innovation for its ability to decrease impurities and improve yield contributing to a greener and more efficient process. Its high selectivity is central to these advantages. Beyond its environmental benefits these improvements in purity and yield directly enhance overall process efficiency and output quality making it a strategically valuable synthesis route that aligns with both ESG commitments and the exacting standards set by health authorities worldwide.
How is Asymchem actively implementing green chemistry principles like solvent substitution and recycling to reduce environmental impact?
Our implementation of green chemistry is action-oriented focusing primarily on solvent minimization and substitution. We are actively replacing non-green solvents such as DMF and DCM with greener alternatives and reducing overall consumption including that of acetonitrile. Beyond reduction we advance solvent regeneration initiatives. For example, we have programs to capture, purify and reuse acetonitrile within our manufacturing processes. These concrete measures in solvent management directly reduce waste resource use and our environmental footprint.
Many CDMOs are expanding into TIDES. What do you see as Asymchem’s sustainable competitive advantages?
Our most sustainable advantages are our integrated platform proprietary technologies and digital foundation which together future-proof our operations. We offer true seamless integration from drug substance to drug product. We pioneer next-generation scalable processes like TAG-assisted synthesis and continuous processing to meet massive future demand. A commitment to green chemistry by design is embedded in our operations. Critically a digital core powered by PAT and AI ensures real-time control and early impurity mitigation. The technology exists, our differentiator is its effective execution to deliver reliable end-to-end solutions.
How important is proprietary technology (such as enzyme-catalyzed ligation or TAG-assisted LPPS) in setting your platform apart from more standard oligo/peptide providers?
Proprietary technologies are fundamental to our competitive distinction. They are not merely additions but the core enablers of a more sustainable and scalable manufacturing paradigm. For instance, enzymatic ligation is pivotal for reducing impurities and improving yield, aligning process efficiency with green chemistry goals. This approach is backed by over 1,000 unique ligases for peptides and oligonucleotides, respectively. Similarly, TAG-assisted LPPS enables the implementation of green solvent systems that are amenable to liquid-liquid extraction and integrated flow chemistry. Additionally, the lower stoichiometry of amino acids and reagents enhances cost efficiency. These innovations collectively address the scalability limitations and high Process Mass Intensity (PMI) inherent in traditional solid-phase synthesis. The effectiveness of these advanced processes is underpinned by enabling technologies like Process Analytical Technology (PAT), which provides the essential real-time feedback and control to ensure their successful execution, guaranteeing both high product quality and yield. At Asymchem, we believe that competition in the TIDES space has long transcended mere capacity. It is now fundamentally about technology. Our sustainable competitive edge lies in our commitment to building, and continually advancing, the technical capabilities required to meet any client challenge.
