As a new type of foreign trade service provider driven by technological transformation and foreign trade business, HiSiaddi has established a "1+2+3+4=1" service system and can supply chitosan sourced from multiple well-known original manufacturers. Possessing R&D capabilities, HiSiaddi has repeatedly collaborated with factories on technological transformation and accurately captured market demands to resolve customers’ customized chitosan requirements. Below is a case illustrating how HiSiaddi addressed customized chitosan demands.
Please contact HiSiaddi customer service if you require more customized service solutions.
The buyer is BioPharma Berlin GmbH, a mid-to-high-end local biopharmaceutical enterprise based in Berlin, Germany. It focuses on three core product lines: mucosal targeted delivery preparations, medical wound repair dressings, and high-end oral sustained-release dietary capsules. Its products comply with EU EDQM standards, Germany’s LMBG Food and Pharmaceutical Act, and LFGB safety standards, and are sold in chain public hospital pharmacies across Germany as well as premium organic health product retail zones of dm and Rossmann high-end beauty & health chains. It is a high-quality mid-to-high-end customer with refined raw material procurement standards, with an annual total chitosan procurement volume of 12.6 tons, divided into three customized specifications: injectable low-molecular water-soluble chitosan, quaternary ammonium modified chitosan for mucosal adhesion, and high-molecular film-forming chitosan for medical dressings.
The customer previously sourced high-end customized chitosan from manufacturers in Iceland (Northern Europe) and the United States for a long time. However, European and American raw material suppliers reduced production capacity in 2025, raised quotations by 32%, and extended customized production lead times to over 90 days, hindering the launch plan of its new product R&D pipeline. The customer thus planned to replace imported raw materials with domestically produced Chinese alternatives.
The customer independently contacted three leading domestic chitosan manufacturers: Zhejiang Golden-Shell, Qingdao Marine Biotechnology, and Shandong Yingke, and put forward three refined customized technical indicators. Nevertheless, all domestic manufacturers operated mass production lines for standard general-purpose chitosan and failed to meet the customer’s personalized requirements for modification, precise molecular weight grading, and strict endotoxin control. Six consecutive batches of test samples failed actual testing, stalling formulation laboratory R&D and delaying the new product launch schedule. Upon industry recommendation, the customer fully entrusted HiSiaddi to coordinate the entire chain of services, including customized R&D with domestic factories, pilot sample production, and mass production implementation.
The customer specified three mandatory customized technical indicators (tailored to formulation production processes, no standard off-the-shelf products available on the market):
1. Injectable low-molecular chitosan: deacetylation degree 92%±1%, weight-average molecular weight controlled at 22000–26000 Da, viscosity of 1% acetic acid solution 35–42 mPa·s, bacterial endotoxin ≤0.12 EU/mg, water solubility ≥99.2%, for use as drug carriers in injection solutions;
2. Quaternary ammonium modified chitosan (special for oral mucosal preparations): quaternary ammonium substitution degree 38%±2%, deacetylation degree 88%, soluble in cold water, stable for 18 months without precipitation at room temperature under pH 5.0 environment, enabling sustained drug release via mucosal adsorption;
3. High-molecular chitosan for dressings: molecular weight 750,000–800,000 Da, deacetylation degree 90.5%, excellent film-forming ductility, bacteriostatic rate ≥99%, suitable for the production of sterile medical hemostatic dressings.
The mainstream mass-produced chitosan from the three domestic factories featured broad molecular weight ranges: conventional low-molecular products spanned 10,000–50,000 Da, while high-molecular products ranged from 600,000–1,000,000 Da. Traditional high-temperature alkaline hydrolysis processes could not precisely lock the narrow molecular weight ranges specified by the customer, with the molecular weight dispersion coefficient of conventional alkaline hydrolysis exceeding 30%. After feeding into formulations, inconsistent drug release rates were observed, leading to total failure of all laboratory small-scale trials. Most manufacturers lacked enzyme digestion and grading refining production lines and were unwilling to revamp production lines to undertake small-batch customized R&D.
The customer required targeted chemical modification via quaternary ammonium reaction, yet domestic factories only performed simple general hydroxypropyl modification without refined controllable quaternary ammonium synthesis workshops. The modification substitution degree fluctuated widely between 25% and 52%, resulting in stratification, precipitation, and insufficient adhesion in oral preparations.
The domestic internal control limit for endotoxin of conventional pharmaceutical-grade chitosan is 0.25 EU/mg, higher than the customer’s mandatory injectable-grade requirement of ≤0.12 EU/mg. Conventional impurity removal processes used by factories could not eliminate trace proteins and heavy metals. Factory self-inspection reports only complied with the Chinese Pharmacopoeia, without English-language COAs tested in accordance with EP European Pharmacopoeia and USP Pharmacopoeia, failing to meet German drug administration filing requirements for warehouse storage.
Manufacturers merely produced goods based on their own processes and did not cooperate with the customer’s German laboratory to optimize formulations. When performance abnormalities appeared in test samples, no technical staff were assigned to trace and adjust production processes, leaving the customer to bear all R&D trial-and-error costs. Cumulative expenses for test samples and laboratory testing exceeded EUR 28,000.
Drawing on its full industrial chain resources for chitosan, HiSiaddi eliminated general large manufacturers unable to implement technical revamps for mass customization and selected two source factories with customized R&D capabilities: Shandong Yingke Biotechnology (equipped with GMP medical production lines and patented enzymatic refining technology) and Zhejiang Golden-Shell Biotechnology (with a pilot workshop for fine modification). Production tasks were split by product category: Shandong Yingke took charge of customized low-molecular injectable chitosan and high-molecular dressing-grade chitosan, while Zhejiang Golden-Shell specialized in R&D of quaternary ammonium modified chitosan.
HiSiaddi led the formation of a three-party joint customization team consisting of the customer’s German R&D department, factory process engineers, and a third-party CNAS-accredited testing institution. Unified bilingual Chinese-English technical documents were formulated, and European Pharmacopoeia indicators were converted into internal production standards for factories.
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Customization of Low-Molecular Injectable Chitosan HiSiaddi coordinated Yingke to discontinue traditional high-temperature strong alkaline hydrolysis and adopt directional biodegradation by chitosanase combined with membrane separation grading refining. Chitosanase was added in batches to precisely break molecular chains, and nanofiltration membrane grading was applied to remove components with excessively large or small molecular weights, controlling the molecular weight dispersion coefficient below 8%. Multi-stage activated carbon impurity removal and ultrafiltration endotoxin removal processes were optimized to stably maintain product endotoxin levels within 0.10–0.12 EU/mg. Five gradient small-batch trial samples were produced, each undergoing full testing per EP Pharmacopoeia at an ISO17025-certified domestic laboratory with English batch COAs issued. Three consecutive batches of samples met all indicator ranges specified by the customer.
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Targeted Synthesis Customization of Quaternary Ammonium Modified Chitosan Golden-Shell revamped sealed modification reaction kettles, controlling reaction temperature, feed molar ratio, and pH environment. Quaternary ammonium reagents were added dropwise in stages, with substitution degree monitored via real-time sampling. After 21 rounds of small trials adjusting process parameters, the quaternary ammonium substitution degree was stably locked between 37.2% and 39.5%. The finished product achieved full solubility in cold water at room temperature, with no precipitation observed after a 12-month accelerated stability test under weak acid pH 5 conditions, matching the formulation requirements of the customer’s oral sustained-release preparations.
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Refining Optimization of High-Molecular Chitosan Specialized for Dressings Raw material sources of shrimp shells were strictly controlled (preferring deep-sea Norwegian shrimp shells to avoid heavy metal contamination risks from offshore raw materials). Low-temperature staged deacetylation was adopted to prevent damage to high-molecular chain structures caused by high temperatures, precisely locking the molecular weight at approximately 760,000 Da with a deacetylation degree of 90.3%. Spray drying processes were optimized to improve powder uniformity, and film tensile properties as well as bacteriostatic indicators passed third-party pharmacological testing in Germany.
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HiSiaddi coordinated sample packaging with sterile vacuum aluminum foil bags and shipped samples in three phases: small trial → pilot production → mass production test samples. Each batch of samples was accompanied by EP/USP bilingual quality inspection reports, production process traceability documents, notarized GMP production materials, non-animal allergen statements, and non-irradiation processing certificates.
The customer’s German R&D laboratory conducted formulation compatibility, accelerated stability, and cell biocompatibility tests. In response to minor performance deviations identified during testing, HiSiaddi coordinated factories to adjust production parameters in real time. After three rounds of fine-tuning, all three customized products passed formulation pilot tests and were ready for direct industrial production.
Following full compliance of pilot testing, HiSiaddi assisted the customer in splitting the annual framework procurement order of 12.6 tons: ① 4.2 tons of low-molecular injectable chitosan, produced in 8 evenly distributed monthly batches; ② 3.8 tons of quaternary ammonium modified mucosal-specialized chitosan, produced in 6 batches; ③ 4.6 tons of high-molecular dressing-grade chitosan, stocked in 5 batches.
Light-proof vacuum sterile packaging was customized in compliance with German import regulations, with bilingual German-English product labels marked with CAS numbers, raw material sources, and EU raw material filing codes. HiSiaddi coordinated export customs clearance and certificate of origin processing, enabling the customer to reduce German import tariffs via FORM A certificates of origin.
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Customer Benefits ① Successful replacement of imported raw materials with domestic alternatives enabled the timely launch of three new products in Germany, covering three production lines for medical injection excipients, oral prescription drugs, and high-end sterile dressings. Local German revenue generated by the products exceeded EUR 2.16 million in the first year post-launch. Domestic procurement reduced comprehensive chitosan purchasing costs by 24.7%, eliminating reliance on overpriced European and American raw materials and uncontrollable delivery cycles. ② Process standards and quality inspection documents for the full set of customized products are reusable. In the following year, the customer added customized low-oligomeric chitosan for children’s probiotic products, expanding annual procurement volume to 17.3 tons. It also fully entrusted HiSiaddi with all chitosan raw material procurement for its Austrian and Czech subsidiaries.
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Benefits for Manufacturing Factories Supported by this high-end customized R&D project, the two cooperating factories refined process systems for EU Pharmacopoeia-grade customized chitosan, filling technical gaps in mass production of injectable and modified chitosan. Leveraging compliant products and complete export qualifications, they subsequently secured customized orders from three mid-to-high-end pharmaceutical enterprises in the Netherlands and Denmark, opening up high-end EU biomaterial supply chains and upgrading their product positioning from domestic general bulk goods to high-end customized raw materials.
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Realized Service Value of HiSiaddi Beyond positioning itself as a simple trading intermediary, HiSiaddi acts as a third-party technical service provider bridging customized demand from overseas mid-to-high-end customers and technical transformation R&D at domestic factories. It addresses full-chain pain points including customized process development, indicator control, cross-border technical communication, and export compliance, forming a standardized full-cycle service solution for customized chitosan supply to European and American pharmaceutical enterprises.
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Most domestic chitosan manufacturers focus on mass production of general bulk products, with production lines and processes designed for standard off-the-shelf goods. They lack supporting R&D capabilities for refined modification, narrow-range molecular weight grading, and ultra-high-purity medical-grade customization. Mid-to-high-end overseas pharmaceutical customers are bound by stringent EU pharmacopoeia requirements with highly refined customized parameters, and independent communication with factories often leads to mismatched processes, repeated failed sample testing, and delayed R&D schedules.
Relying on full industrial chain resource integration and cross-domain technical coordination capabilities, HiSiaddi delivers one-stop personalized customization solutions across six dimensions: factory screening, technical process transformation, sample iteration, formulation coordination, mass production implementation, and export compliance. It not only helps overseas mid-to-high-end customers replace imported raw materials with domestic alternatives and cut procurement costs, but also empowers high-quality domestic chitosan manufacturers to upgrade high-end product technologies and access the global high-end pharmaceutical supply chain. This case serves as a benchmark for foreign trade enterprises delivering high-end customized trade via technical services.
Please contact HiSiaddi customer service for more customized service solutions.
+86-13120989737 
info@hisiaddi.com 
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