As a new-type foreign trade service provider driven by dual engines of technology transformation and foreign trade services, HiSiaddi has built a "1+2+3+4=1" service system and can supply hyaluronic acid sourced directly from multiple well-known original manufacturers. As a R&D-oriented foreign trade service provider, HiSiaddi has repeatedly collaborated with factories on technology conversion and accurately captured market demands to resolve customers’ customized requirements for hyaluronic acid products. Below is a case of HiSiaddi addressing customized demands for hyaluronic acid products.
Please contact HiSiaddi customer service if you require more customized service solutions.
The purchaser, DermaMed Medical Aesthetics Group based in Hamburg, Germany, is a leading compliant medical pharmaceutical enterprise in Northern Germany. It operates three core business segments: Class III medical device dressings, medical injection filling raw materials, and sterile post-procedure repair serums for beauty salons. All its products fully comply with the European Pharmacopoeia (EP), Germany’s LFBG Cosmetic and Medical Raw Material Act, EU GMPD medical production specifications, and REACH chemical regulations. Its products are supplied to 412 private dermatology hospitals, chain medical aesthetics clinics and high-end pharmacies across Germany. Its long-term supply chain for hyaluronic acid previously relied on two major overseas suppliers: BASF Germany and Shiseido Pharmaceutical Division Japan. The group purchases a total of 55 tons of full-spec pharmaceutical-grade hyaluronic acid quarterly every year, divided into three application categories:
1. Ultra-low molecular weight HA: For post-aesthetic procedure wound dressings
2. Medium molecular weight HA: Used as raw liquid for superficial dermal injection filling
3. High molecular weight HA: Suitable for deep contour shaping injections and high-moisture sterile serums
In 2025, the group launched a global supply chain optimization project, aiming to realize domestic substitution in China by leveraging China’s cost and process advantages in bio-fermentation industry. It rejected standard domestic daily chemical and food-grade off-the-shelf hyaluronic acid circulating in the market, requiring full non-standard customization of all raw material parameters. The client conducted on-site visits to four major domestic HA mass producers: Bloomage Biotech, Fufeng Biotech, Focus Biotech and Shandong Anhua Biochemical to negotiate customized production, yet encountered common pain points across the mass production industry: The main production lines of the four manufacturers operate standardized continuous large-capacity production with fixed equipment parameters, fermentation formulas and enzymatic hydrolysis sections. Core production capacity is allocated to mass-produced low-cost hyaluronic acid for daily chemicals, feed and food additives. Non-standard customization requires production line shutdown to reconstruct fermentation tank feeding systems, reconfigure temperature control curves for enzymatic digestion, add multi-stage ultrafiltration depyrogenation production lines, and activate Class 10,000 sterile lyophilization packaging workshops. Technical modification for a single batch will crowd out production capacity for existing off-the-shelf orders, featuring long commissioning cycles and high loss costs. All four manufacturers only agreed to sell their standardized stock grades and declined refined gradient sampling and full-indicator customization requests.
Blocked by raw material supply constraints, the R&D and mass production of the group’s new Class III wound repair dressings and new mild medium-molecular injection fillers were suspended, delaying the original Q3 EU filing and launch plan for new products and exposing the brand to risks of market seizure by European competitors. DermaMed finally entrusted HiSiaddi with full overall coordination of the whole customized production chain, covering process docking, phased sampling, production line technical modification coordination, full-item testing, compilation of EU compliance documents, export customs declaration and pre-import review in the destination country.
General domestic food/daily chemical-grade HA only meets basic national standard purity requirements, while all internal control thresholds for German injectable raw materials are tightened, with itemized parameters as follows:
1. Ultra-low molecular weight hyaluronic acid: 800Da±100Da, polydispersity index PD＜1.3, exclusively for penetration-promoting formulations of post-procedure dressings. Conventional small-molecule HA available on the market generally has a molecular weight range of 500–2000Da with PD values of 1.5~2.0; excessive molecular weight dispersion disqualifies it for medical penetration-promoting raw materials.
2. Medium molecular weight hyaluronic acid: 1,200,000Da±50,000Da, PD＜1.28, suitable for superficial dermal injection, balancing supporting force and human degradation rate.
3. High molecular weight hyaluronic acid: 2,200,000Da±80,000Da, PD＜1.25, for deep contour filling with long-lasting shaping and slow release effects.
· Endotoxin: ＜0.03EU/mg (the limit for ordinary domestic medical-grade products is 0.5EU/mg, while mass-produced commercial products generally range from 0.15~0.3EU/mg)
· Protein residue: ＜0.01%; Nucleic acid residue: ＜10μg/g, eliminating risks of subcutaneous injection sensitization and inflammatory swelling
· Heavy metals (lead, arsenic, cadmium, mercury): Single item ≤0.2ppm; Residual solvents (methanol, ethanol, acetone): ＜3ppm, complying with EU ICH Q3C solvent control specifications
Abandoning the composite fermentation medium of animal peptone and animal protein peptone commonly used in the industry, the production adopts a fully plant-based carbon and nitrogen source formula for fermenting Streptococcus zooepidemicus, consisting of corn glucose, hydrolyzed soybean nitrogen source and wheat bran extract. Finished products meet EU vegetarian raw material certification and clean label requirements, avoiding overseas registration obstacles caused by residual animal-derived proteins, and matching the positioning of Germany’s local organic medical beauty product lines.
1. Sterile lyophilized powder: Individually packed in 2kg vacuum light-proof aluminum foil bags, lyophilized in Class 10,000 clean workshops, free of exogenous bacteriostatic agents and ethylene oxide residues.
2. 5% sterile hyaluronic acid stock solution: Packed in 25L food-grade sterile nitrogen-sealed barrels, prepared via terminal ultrafiltration sterilization under fully nitrogen-sealed closed conditions with zero preservatives added, directly used for filling salon repair serums.
1. Fixed mass production lines and manufacturers’ insufficient motivation for technical modification Standardized fermentation sections of domestic manufacturers feature fixed feeding ratios; temperature, pH and enzyme dosage in enzymatic hydrolysis kettles are set as fixed mass production parameters. Replacing plant-based culture medium requires emptying an entire 50m³ fermentation tank batch, resulting in loss of dozens of tons of off-the-shelf order capacity per shutdown, damaging short-term economic benefits and discouraging factories from deploying flexible production lines separately.
2. Insufficient depyrogenation process capacity Conventional production only adopts 1–2 stages of rough filtration for impurity removal. To reduce endotoxin to the ultra-low threshold of 0.03EU/mg, supporting processes of four-stage nanofiltration, multi-stage ultrafiltration gradient depyrogenation and refined activated carbon adsorption must be added, which most daily chemical-oriented production lines lack.
3. Hardware gaps for sterile packaging Fufeng Biotech and Shandong Anhua Biochemical have no Class 10,000 sterile lyophilization workshops, only open powder packaging lines unsuitable for producing sterile lyophilized powder and preservative-free stock solutions for injection. Focus Biotech’s sterile workshops are fully booked with self-owned off-the-shelf injectable product orders, leaving no spare capacity for temporary scheduling.
4. Lack of cross-border compliance documents The four manufacturers can only issue Chinese national standard COAs, without the capability to prepare full English itemized quality inspection reports, SCCS raw material safety assessment reports and REACH registration dossiers in accordance with EP Pharmacopoeia and Germany’s LFBG regulations, making raw materials unable to pass pre-import review by German drug authorities.
HiSiaddi screened enterprises item by item based on production line qualifications, refined workshop configurations and past EU export track records:
1. Fufeng Biotech: Core capacity focuses on bulk feed and daily chemical-grade HA, lacking medical deep refining and sterile lyophilization production lines → Eliminated
2. Shandong Anhua Biochemical: Small and medium-sized daily chemical raw material manufacturer without precise controllable enzymatic hydrolysis equipment for narrow-distribution molecular weight grading → Eliminated
3. Focus Biotech: Food-grade HA accounts for the majority of revenue; sterile workshop capacity is fully occupied, unable to accommodate customized non-standard production scheduling → Eliminated
4. Selected Bloomage Biotech Medical Raw Material Division: One of the few domestic producers equipped with flexible pilot fermentation lines, Class 100,000 deep refining workshops and Class 10,000 sterile lyophilization packaging workshops. It possesses mature R&D processes for EP Pharmacopoeia-grade injectable HA and has long supplied medical beauty brands across Europe.
HiSiaddi secured cooperation by signing an annual long-term order of 55 tons and a special customized framework agreement, defining a three-stage implementation model: 10kg laboratory trial production → 150kg pilot scale-up → mass standardized production. The costs of production line technical modification and commissioning losses are shared by stage, with unqualified samples excluded from formal orders and mass production scheduling only initiated after indicators meet standards, eliminating manufacturers’ concerns over losses from customization.
1. Optimization & replacement of fermentation formula: Completely remove animal peptone raw materials, adopt composite plant medium with 45g/L glucose, 22g/L hydrolyzed soybean protein and 8g/L wheat bran leachate, conduct closed fermentation at precise 37℃ under inert nitrogen isolation to suppress by-product generation from bacterial metabolism and reduce protein and nucleic acid impurity residues at the source.
2. Segmented controllable enzymatic hydrolysis for molecular weight regulation: Adopt patented gradient temperature-controlled targeted enzymatic digestion technology, precisely control enzyme dosage, water bath temperature and hydrolysis duration in three segments to separately cut raw materials into three target molecular weight grades. After three rounds of sample retesting, the molecular weights of all three products fall within the client’s tolerance range with stable PD values of 1.22~1.28, satisfying narrow distribution requirements.
3. Four-stage purification for deep depyrogenation: Fermentation stock undergoes centrifugation to remove bacterial bodies → rough filtration for macromolecular impurity removal → four-stage nanofiltration grading → ultrafiltration for endotoxin removal + activated carbon adsorption for deproteinization. Final finished products are tested with endotoxin of 0.022EU/mg and protein residue of 0.007%, all indicators superior to German market access standards.
4. Sterile sample packaging: 10kg sterile powder + 5kg sterile stock solution are packed in Class 10,000 lyophilization workshops, double-layer vacuum aluminum foil sealed and air freighted to Hamburg, Germany. The client’s laboratory conducts full in vitro tests including formula compatibility, cell irritation and skin sensitization: the medium-molecular weight raw liquid compounded for injection shows no redness or irritation, the ultra-low molecular weight dressing achieves qualified transdermal absorption rate, and the high-molecular weight filler gel meets the formulation parameters of German filling agents.
HiSiaddi deploys chemical QC specialists to be stationed at the factory, fully standardizing complete standardized production procedures including fermentation pH, dissolved oxygen, enzymatic hydrolysis time and purification pressure, with customized exclusive SOP documents retained by the factory. Sterile stock solution is prepared under closed nitrogen environment, sterilized via 0.22μm terminal ultrafiltration and sealed in nitrogen-filled barrels. Pilot finished products are simultaneously sent to domestic CNAS laboratories and German SGS third-party laboratories for full-item testing against both China’s YY/T standard and EP European Pharmacopoeia. Outer packaging adopts customized light-proof thickened aluminum foil with moisture-proof desiccants to adapt to long-distance ocean transportation with moisture, bacteria and oxidation control requirements.
The 55-ton annual order is finely split: 37 tons of sterile lyophilized solid powder (for injection filling and wound dressings) and 18 tons of 5% preservative-free sterile stock solution (for salon repair serums). Production is evenly scheduled in 8 monthly batches to avoid capacity conflicts during the factory’s peak season for off-the-shelf products, with fixed shipments in the middle-to-late month departing from Shanghai Port directly to Hamburg Port.
1. Bilingual quality inspection reports: Bilingual Chinese-English COAs prepared item by item in accordance with EP Pharmacopoeia, separately listing full measured data of molecular weight, endotoxin, protein, nucleic acid, heavy metals, solvent residues and microorganisms, sealed with the factory’s special medical quality inspection stamp.
2. Chemical compliance documents: Full English MSDS compiled in accordance with EU CLP and GHS Version 6 new regulations, detailing hazard classification, storage & transportation specifications, first-aid instructions and REACH information; SCCS medical raw material safety assessment report compiled simultaneously for German LFBG raw material review.
3. Assistance with pre-import review: Sort out full-chain raw material production traceability ledgers (strain source → feeding records → purification records → batch test reports), assist DermaMed in completing EU CPNP raw material notification and pre-filing of imported raw materials with Hamburg Food and Drug Administration in Germany, eliminating customs inspection warnings for the destination country in advance.
All batches are shipped from Shanghai to Hamburg Port with zero customs inspection and zero detention, fully compliant without objections. Customized hyaluronic acid is successfully put into mass production, and three new products (injection fillers, post-aesthetic procedure dressings and sterile repair serums) pass German drug filing on schedule, fully launched in over 410 private medical aesthetics and dermatology hospitals across Germany. Compared with original imported raw materials from BASF and Shiseido, the comprehensive raw material procurement cost decreases by 30%, enabling synchronized optimization of terminal product pricing and a 12% year-on-year increase in brand market share. One year after project launch, DermaMed renewed the 62-ton annual framework procurement order and simultaneously added customized demand for two new products: cross-linked hyaluronic acid derivatives and ultra-low molecular weight hydrolyzed HA.
Supported by this benchmark customized order for high-end medical use in Germany, standardized customized processes for three EP Pharmacopoeia-grade graded HA specifications are implemented. This customized grade achieves a 32% export premium. Relying on German compliance filing documents and product test data, the factory subsequently secured customized sample orders from multiple medical aesthetics groups in the Netherlands, Austria, Switzerland and other EU countries, steadily growing revenue in the medical export segment.
A complete customized service system for hyaluronic acid is established: plant-based fermentation formula modification → precise segmented enzymatic hydrolysis for molecular weight control → multi-stage impurity & endotoxin removal → dual-form sterile packaging → full-chain EU compliance support → cross-border export customs declaration & pre-review. Leveraging this service logic, the business extends customized foreign trade services for high-end medical bio-polysaccharide raw materials including polyglutamic acid, β-glucan and β-hydroxy acid.
The core production capacity of major domestic hyaluronic acid enterprises focuses on mass-produced low-cost off-the-shelf products for daily chemicals and food, with standardized fixed production line processes. Manufacturers generally resist non-standard technical modification due to production cost considerations. In contrast, mid-to-high-end EU medical pharmaceutical brands are bound by strict EP Pharmacopoeia and local national medical regulations, presenting rigid customized requirements in raw material source, impurity limits, molecular weight precision and sterile indicators, which cannot be met by general off-the-shelf raw materials for injectable formulations.
Relying on full industrial chain resources, HiSiaddi eliminates manufacturers’ concerns over technical modification investment through medium-to-long-term annual procurement long-term orders, implements customized indicators across the entire production chain from upstream fermentation sources, midstream purification & enzymatic hydrolysis to downstream sterile packaging, and fills gaps in cross-border compliance. It breaks core barriers for domestic high-end pharmaceutical hyaluronic acid to enter the mid-to-high-end European medical raw material supply chain, achieving a three-way win-win situation: overseas clients reduce costs, domestic factories upgrade products and foreign trade service providers accumulate service systems.
Please contact HiSiaddi customer service if you require more customized service solutions.
+86-13120989737 
info@hisiaddi.com 
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