A full-chain chemical synthesis CRO technology platform covering synthetic biology, compound structural modification & resolution, chiral compound process development, and genotoxic impurity control. Built on 60+ industrialized mature processes, delivering process R&D and regulatory support from milligram-scale route exploration to kilogram-scale-up validation — fully compliant with ICH guidelines and CDE review requirements.
Chemical synthesis is the starting point of drug R&D. An efficient, robust, and scalable synthetic route determines whether a product candidate can successfully transition from the lab to industrialization. Taikomed's synthesis technology platform, anchored by 60+ validated mature processes, has built systematic capabilities in synthetic biology, chiral technology, and impurity control.
Green synthesis of key intermediates and APIs using engineered microorganisms and enzyme-catalyzed systems. Covers gene mining, enzyme directed evolution, whole-cell catalysis, and in vitro multi-enzyme cascade reactions. Provides biocatalytic alternatives for bottleneck steps in traditional chemical synthesis — those with long step counts, low yields, and poor selectivity — significantly reducing waste emissions and production costs.
Targeting lead compound optimization and generic drug patent-circumvention strategies, providing prodrug design, salt/co-crystal screening, polymorph studies, deuterium modification, and fluorine modification solutions. Combined with preparative chromatography, chiral resolution, and dynamic kinetic resolution for efficient separation and purification of enantiomers and diastereomers.
Chiral drug process development is one of the most challenging directions in synthesis technology. The platform possesses asymmetric catalytic synthesis, chiral auxiliary induction, chiral pool strategy, enzymatic kinetic resolution, and preferential crystallization — a full arsenal of chiral technology approaches. Optimal process routes are tailored for different chiral center construction requirements, balancing ee value, yield, and scale-up feasibility.
Based on ICH M7 guidelines, systematically assess the risk of potential genotoxic impurity (GTI) introduction along the synthetic route. Achieve impurity process control and clearance (purge) through process parameter optimization (temperature, pH, molar ratio, addition sequence, etc.), combined with (Q)SAR tools such as DEREK/Sarah for toxicological assessment, ensuring API quality meets the Threshold of Toxicological Concern (TTC) requirements.
Full-spectrum impurity control covering process impurities, degradation products, residual starting materials, residual solvents, and elemental impurities. Structural identification and source tracking of impurities through LC-MS, GC-MS, ICP-MS and other platforms, establishing a comprehensive impurity profile from starting materials to final product — providing data support for process optimization and regulatory filing.
Taikomed's synthesis technology platform has accumulated 60+ mature processes validated through industrial production, covering key intermediates and APIs across therapeutic areas including oncology, cardiovascular, CNS, and anti-infectives. Each process has been verified through kilogram-scale-up, possessing complete process parameter packages (temperature windows, stirring parameters, crystallization curves, drying protocols) — ready for direct technology transfer and regulatory filing.
Core capabilities: Route feasibility assessment → DoE process parameter optimization → Kilogram-scale-up → Process validation batch production → Cleaning validation → CTD Module 3.2.S.2 authoring
A seven-step standardized workflow from client requirements to industrial delivery, with technical review and quality gating at each node.
Literature/patent search
Retrosynthetic analysis
Starting material assessment
mg ~ g scale exploration
Critical parameter screening
Initial impurity identification
DoE experimental design
Impurity purge strategy
Chiral control plan
100 g ~ kg scale-up
Mass & heat transfer assessment
Critical process parameter confirmation
Impurity profiling
GTI assessment & control
Method development & validation
Three-batch process validation
Cleaning validation
Intermediate quality specifications
CTD dossier authoring
DMF filing support
Deficiency response
Not laboratory routes — these are proven processes that have run through kilogram-scale batches, ready for direct technology transfer and GMP production.
Hybrid route design capability combining enzyme catalysis with chemical synthesis, using biocatalysis to resolve the pain points of long step counts and poor selectivity in traditional synthesis.
From asymmetric catalysis to chiral resolution — multi-route parallel evaluation capability, never reliant on a single approach.
Genotoxic impurity assessment, classification, process control, and clearance studies are fully compliant with ICH M7 and the latest CDE review requirements.
Seamless collaboration between synthesis and pharmaceutical analysis teams, forming a closed loop of impurity identification → source tracing → process optimization.
Regulatory compliance is considered from the route design stage — starting material selection, process description, and impurity control strategy are all aligned with CTD filing requirements.
The synthesis technology platform is deeply integrated with Taikomed's other core technical capabilities, forming a complete technical chain from synthesis to finished dosage forms.
API particle size, polymorph, and solubility impact SR/CR release behavior; synthesis provides tailored API
API physicochemical properties determine nano-formulation encapsulation efficiency and stability; synthesis provides high-purity starting material
Drug-loaded lipid emulsions have strict API logP requirements; synthesis can perform targeted molecular modification
Depending on the project stage: route exploration typically starts from mg ~ g scale; process optimization can operate in the 10 g ~ 500 g range; industrial scale-up supports kg to tens-of-kg scales. We configure flexibly based on actual client needs.
Covering oncology (TKIs, antibody-drug conjugate payloads), cardiovascular (sartans, statins), CNS (antidepressants, antiepileptics), anti-infectives (antivirals, antifungals), metabolic (antidiabetic, urate-lowering), and multiple other therapeutic areas.
Yes. Our GTI control strategy is strictly executed per ICH M7(R2) guidelines, including (Q)SAR assessment, classification confirmation, acceptable limit calculation, process purge factor studies, and confirmatory testing method development — fully satisfying CDE's latest review standards and common deficiency inquiry areas for GTI control.
Synthetic biology projects require an initial 2-4 months for strain construction and enzyme screening. However, once an efficient biocatalytic system is established, subsequent scale-up and production efficiency far exceeds traditional synthesis. Overall delivery timelines range from 6 to 18 months depending on project complexity.
Whether it is a novel route development, process optimization and scale-up, or genotoxic impurity control strategy — our synthesis technology team can provide a technical feasibility assessment in the shortest possible time.
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