From raw botanical characterization to high-purity single-compound isolation and pre-clinical trial packages, explore our validated contract development programs.
Modern therapeutic development demands reproducibility that traditional, unstandardized botanical extraction cannot satisfy. As regulatory bodies enforce stringent pharmacopeial standards across North America, Europe, and Asia-Pacific, the global botanical market is pivoting toward fully characterized, clinically validated active botanical substances (ABS).
Wild and cultivated botanical feedstocks suffer from pronounced seasonal, geographic, and genetic variances. MedGence solves raw biomass volatility by establishing rigorous botanical fingerprinting using HPLC-DAD and LC-MS/MS, calibrating raw material acquisition against quantified secondary metabolite profiles rather than crude dry weight.
Thermal degradation often damages delicate terpenes, glycosides, and volatile fractions during conventional hydro-ethanolic reflux. We engineer clean-label subcritical solvent networks and Supercritical CO2 (scCO2) architectures with green entrainers, securing thermolabile bioactives while eliminating toxic halogenated residue concerns.
International pharmacopeias (USP <561>, EP 2.8.13) dictate hyper-low thresholds for pesticide residues, mycotoxins, and heavy metals (Pb, As, Cd, Hg). Our integrated extraction units incorporate advanced microporous resin chromatography, molecular sieving, and supercritical fractionation to eliminate agrochemical residues natively.
MedGence (Yineng Pharma) closes the industry divide between upstream laboratory discovery and downstream industrial scale-up. We provide single-stage project intervention or turn-key outsourced pharmaceutical CDMO services.
Systematic isolation and structural elucidation of botanical alkaloids, polyphenols, polysaccharides, and saponins. We link chemical components directly with specific functional responses to select optimal high-potency candidates.
Phytochemical density fluctuates heavily across microclimates. We execute cross-regional multi-harvest sampling across 31 provinces, establishing geo-specific harvest calendars to maximize active yields per metric ton.
Full validation of qualitative and quantitative testing regimes under ICH Q2(R1) guidelines, establishing chromatographic fingerprinting, reference standards, and stability-indicating analytical assays.
Optimization of raw biomass pretreatment, continuous countercurrent extraction, column adsorption kinetics, membrane ultrafiltration, and vacuum freeze-drying to maximize commercial profitability.
Overcoming hygroscopicity, poor aqueous solubility, and volatile degradation during formulation. We develop microencapsulation, liposomal carriers, and solid dispersion strategies for stable final dosing.
Investigational safety dossiers including acute LD50 determinations, 28/90-day sub-chronic and chronic toxicity studies, Ames bacterial reverse mutation, and mammalian chromosomal aberration profiles.
High-throughput primary cell line assays exploring anti-inflammatory pathways (NF-κB, COX-2), antioxidant capacity (ORAC, DPPH), enzymatic inhibition (α-glucosidase), and skin barrier enhancement mechanisms.
Animal efficacy studies across validated disease models (metabolic syndrome, neuroprotection, immune modulation, gastrointestinal integrity) providing statistically sound dosing references.
GCP-compliant human clinical trials ranging from pilot efficacy trials for nutraceutical substantiation to comprehensive multicenter Phase I through Phase IV trials for botanical New Drug Applications (NDA).
Translating empirical Traditional Chinese Medicine (TCM) synergy into molecular chemistry. Having modernized 83 classic formulas, we preserve multi-target efficacy while achieving Western analytical clarity.
Commercial-scale contract supply delivering high-titer concentrated extracts, customized powders, standardized active pastes, and supercritical essential oils under strictly managed NDAs.
End-to-end CDMO production of market-ready dosage forms: liquid oral ampoules, softgels, vegetarian hard capsules, enteric-coated tablets, functional effervescents, and sublingual granules.
Selecting the optimal thermodynamic extraction mechanism directly influences target compound bioactivity, solvent recovery overhead, and impurity profiles. MedGence maintains all four commercial platforms at pilot and commercial scale.
| Extraction Technology | Primary Target Compounds | Operating Temp / Pressure | Solvent System | Purity Threshold | Thermolabile Stability |
|---|---|---|---|---|---|
| Supercritical CO2 (scCO2) | Lipophilic terpenes, phytosterols, essential oils, cannabinoids | 31.1°C – 55°C / 73.8 – 350 bar | CO2 (Food/Pharma Grade) ± EtOH co-solvent | Up to 98% in targeted lipid fractions | Exceptional (Zero thermal degradation) |
| Continuous Countercurrent Ethanolic | Polyphenols, flavonoids, saponins, triterpenoids | 45°C – 70°C / Atmospheric | Deionized Water : Ethanol gradient (20-95%) | 40% – 85% enriched crude fractions | High (Short exposure duration) |
| Enzymatically-Assisted Aqueous | High-molecular polysaccharides, peptides, water-soluble alkaloids | 40°C – 55°C / Controlled pH 4.5–6.5 | Water + Cellulase, Pectinase, Protease complex | 60% – 90% total polysaccharide content | Very High (Mild enzymatic cleavage) |
| Macroporous Resin Adsorption | Monomer purification (Ginsenosides, Salidroside, Curcumin) | Ambient / 2 – 5 BV/h elution flow rate | Crosslinked polystyrene resin + EtOH wash | 90% – 99.5% pure crystalline API | Maximum (Ambient chromatography) |
Navigating international botanical regulations requires nuanced documentation. MedGence pairs Chinese raw supply leadership with rigorous Western regulatory documentation, guaranteeing smooth import audits and market registrations.
Comprehensive audit readiness including Full Batch Records (BPR), Master Manufacturing Records (MMR), identity verification testing against USP monographs, and preparation of New Dietary Ingredient (NDI) and GRAS notifications.
Alignment with European Pharmacopoeia (Ph. Eur.) botanical purity standards. Complete assistance in generating dossiers for Traditional Herbal Medicinal Products (THMPD) and EU Novel Food authorizations under Regulation (EU) 2015/2283.
Full compliance with Good Agricultural and Collection Practices (GACP). Every extraction lot includes DNA barcoding for taxonomic identity, geographic origin metadata, and clean certificates of analysis for ethylene oxide, irradiation, and solvent residues.
Our bioactives and custom formulation matrices serve diverse global industries requiring absolute active potency and verifiable biological mechanisms.
Standardized botanical extracts engineered for metabolic support, cognitive enhancement, healthy sleep cycles, and joint health, adapted for maximum bio-accessibility in gummies, powders, and capsules.
Pharmaceutical grade natural active pharmaceutical ingredients (APIs) supporting oncology adjunct therapies, cardiovascular maintenance, and respiratory care under full DMF/ASMF filings.
Dermatologically proven clean actives providing potent tyrosinase inhibition, accelerated fibroblast synthesis, transdermal anti-glycation, and anti-photoaging shielding for prestige personal care.
Water-dispersible, micro-encapsulated extracts designed specifically for ready-to-drink (RTD) functional beverages, instant stick packs, and fortified functional food matrices with zero off-note flavors.
To maintain commercial competitiveness, MedGence is integrating algorithmic molecular screening and continuous process analytical technology (PAT) into commercial extraction.
Consolidating 14+ years of proprietary HPLC/MS chromatographic data across 400 single-herb standards into searchable algorithmic fingerprinting engines.
Predicting natural active metabolite affinities against human enzymatic targets prior to wet-lab screening, shortening early-stage discovery timelines by over 60%.
Deploying real-time Near-Infrared (NIR) and inline HPLC sensors within commercial extraction lines to automatically adjust solvent-to-feed ratios on the fly.
Pairing biological biotransformation (microbial solid-state enzymatic fermentation) with green subcritical fluid isolation for ultra-rare bioactive glycoside production.
With over 300 scientific researchers and partnerships spanning top-tier pharmaceutical manufacturers and university clinical hospitals, our R&D achievements are quantifiable.
Beijing Tongrentang Group
CR Sanjiu Medical
Sunflower Pharmaceutical
Livzon Pharmaceutical
Dihon Pharmaceutical
Golden Throat Holdings
Direct clarity regarding extraction yields, IP preservation, analytical dossiers, and clinical trial pipelines for prospective enterprise clients.
Select your target research or contract manufacturing service below to initiate confidential feasibility analysis and receive complete technical documentation.
Whether developing a novel botanical drug candidate, isolating high-potency functional actives, or scaling multi-ton cGMP extract production, our scientific leadership is ready to scope your project under full non-disclosure.
