Accelerate pipeline development with our proprietary phytochemical extraction assays, fingerprint validation, and full-phase clinical documentation.
Overcoming the structural limitations of crude extracts through precision separation, verifiable pharmacology, and standardized molecular consistency.
Traditional herbal preparations suffer from batch variability caused by soil chemistry, seasonal fluctuation, and non-target secondary metabolites. MedGence applies targeted molecular isolation techniques to extract single compounds or synergistic fractions with assay purities exceeding 98.0%, eliminating inactive polyphenolic tannins, heavy metal complexes, and pesticide residues.
Purity Range: 95.0% - 99.8% by HPLC-DADGlobal pharmaceutical and nutraceutical manufacturers face stringent compendial requirements (USP-NF, Ph. Eur., JP, ChP). We build validated analytical packages—including 2D-LC finger-printing, residual solvent profiles (ICH Q3C), elemental impurity controls (ICH Q3D), and chiral differentiation—enabling direct DMF filing and frictionless regulatory clearance across Western and Asian authorities.
ICH Q7, Q2(R1), Q3A/C/D CompliantUnlike conventional contract extraction houses that stop at raw powder supply, our integrated CRO ecosystem bridges the gap between phytochemical chemistry and cellular biology. We systematically validate mechanism of action through bioassay-guided fractionation, cell signaling cascades, pharmacokinetic rodent models, and Phase I–IV clinical validation.
83 TCM Classic Formulas ModernizedRigorous quantification methodologies engineered to satisfy FDA botanical guidance, EDQM monographs, and international pharmacopoeial quality standards.
| Analytical Modality | Core Instrumentation | Detection Limit & Sensitivity | Critical Quality Attributes (CQAs) Tested | Regulatory Application |
|---|---|---|---|---|
| HPLC-DAD / UHPLC-UV | Agilent 1290 Infinity II, Waters ACQUITY | LOD < 0.05 μg/mL; LOQ < 0.15 μg/mL | Chemical purity, related substances, chromatographic fingerprinting, peak identity | Ph. Eur. / USP Active Ingredient Release, Batch Consistency |
| LC-MS/MS & Q-TOF | Sciex Triple Quad 6500+, Thermo Orbitrap Exploris | Sub-ppb level (< 0.01 ng/mL) | Unknown degradation impurities, pesticide multi-residue screening (500+ compounds) | ICH Q3A Impurity Characterization, Botanical Drug DMF |
| HPTLC Fingerprinting | CAMAG Automatic TLC Sampler & Visualizer | Semi-quantitative Rf tracking | Botanical authentication, adulteration detection, origin marker profiling | Raw biomass identification (ChP, USP <203>) |
| GC-MS / Headspace GC | Shimadzu GCMS-QP2020 NX with HS-20 | LOD < 0.1 ppm for volatile organics | Class 1, 2, 3 residual extraction solvents, terpene profiling, essential oils | ICH Q3C Solvent Verification, Safety Toxicology |
| ICP-MS Heavy Metal Scan | PerkinElmer NexION 2000 | PPT level (< 10 ng/L) | Lead (Pb), Arsenic (As), Cadmium (Cd), Mercury (Hg), Nickel (Ni) | USP <232>/<233>, EP 5.20 compliance |
| qNMR & Chiral HPLC | Bruker Avance 600 MHz, Chiralpak Columns | Enantiomeric excess > 99.5% | Absolute chemical structure verification, enantiomeric purity, stereochemistry | New Chemical Entity (NCE) and API Patent Submissions |
MedGence's vertically integrated infrastructure eliminates multi-vendor fragmentation, assuring intellectual property security, chemical reproducibility, and supply continuity.
Extracting high-affinity alkaloids, polysaccharides, flavonoids, and triterpenoids using bioassay-guided high-throughput fractions. We systematically determine which compounds deliver target therapeutic effects and identify the richest biological plant species, mitigating supply depletion risks.
Secondary metabolite concentrations fluctuate dynamically based on soil mineralogy, altitude, and harvest intervals. Our geographic and phenological mapping locks in optimal sourcing regions and harvesting windows to maximize active density and reduce downstream production costs.
Developing fully validated HPLC, GC, LC-MS, and HPTLC protocols satisfying ICH Q2(R1) parameters: linearity, precision, repeatability, intermediate precision, specificity, and robustness. Method transfer packages provide seamless in-house adoption for your QA/QC teams.
Engineering pilot-scale supercritical CO2 fluid extraction, continuous simulated moving bed (SMB) chromatography, macroporous resin adsorption, and crystallization kinetic models. We eliminate thermodynamic degradation while maintaining recovery rates above 88%.
Overcoming botanical galenical hurdles: moisture absorption, poor compressibility, oxidation, and organoleptic bitterness. Formulators optimize microencapsulation, spray freeze-drying, and inclusion complexes to ensure extended shelf-life and optimal bio-absorption.
Providing essential safety documentation including Acute Toxicity (LD50), 28-day and 90-day Sub-chronic Oral Toxicity, Ames Bacterial Reverse Mutation, and Mammalian Chromosomal Aberration tests to build robust toxicology dossiers for regulatory authorities.
Target identification using cellular models: HepG2 glucose uptake, RAW264.7 macrophage anti-inflammatory cascades, antioxidant radical-scavenging metrics, and cellular senescence assays, providing decisive go/no-go developmental proof within short timelines.
Validating functional efficacy in disease models: metabolic syndrome, hyperlipidemia, cognitive enhancement, and gut microbiome modulation. Precise animal telemetry and biomarker tracking substantiate supplement claims and preclinical investigational filings.
Conducting randomized, double-blind, placebo-controlled human trials (RCTs). We design protocols, manage GCP institutional ethics reviews, patient recruitment, bio-statistical analysis, and regulatory-grade clinical study reports (CSR) for NDA registration.
Synthesizing Traditional Chinese Medicine (TCM) holistic theory with cutting-edge molecular pharmacology. We formulate optimized synergistic botanical complexes that enhance target bioavailability, receptor binding affinity, and therapeutic performance.
Industrial scale pilot and multi-ton commercial production managed directly by our scientific engineers. Active isolates are supplied as fine crystalline powders, paste-phase complexes, or vacuum-distilled volatile fractions under strict non-disclosure terms.
Turnkey cGMP manufacturing of solid dosage tablets, enteric-coated softgels, vegetarian two-piece hard capsules, sachet soluble granules, and sterile oral liquids. Clean-label, non-GMO, and kosher/halal certifiable production lines.
Customizing chemical purity, particle sizing, dissolution rates, and stability documentation to meet specialized regulatory demands across four multi-billion dollar verticals.
Modern pharmaceutical pipelines focus heavily on secondary plant metabolites as chemical scaffolds for novel drug development. MedGence provides monograph-grade botanical isolates (purity ≥ 98.5%) characterized by single-crystal X-ray diffraction, chiral resolving agents, and stability validation according to ICH Q1A guidelines.
Global consumer demand has transitioned from generic extracts toward clinically validated monomers that deliver measurable metabolic, nootropic, cardiovascular, and immune support. We engineer standardized actives with customized tap densities and improved dissolution rates.
Formulating high-potency cosmeceuticals requires active ingredients free of discoloration-prone tannins, skin-sensitizing volatile fractions, and heavy metals. We isolate pure polyphenols, ginsenosides, and terpenoids designed for superior stratum corneum penetration.
Targeted medical nutrition for clinical post-operative recovery, oncological cachexia, and metabolic disorders requires exact active ingredient concentrations with zero pesticide trace and low endotoxin burdens. Our clean-room spray-drying lines deliver instant cold-water soluble powders.
Harnessing artificial intelligence, deep eutectic solvents, and synthetic biology hybridization to expand botanical extraction yield frontiers.
By simulating phytochemical interaction matrices with artificial intelligence, we predict partition coefficients and resin affinity kinetics prior to wet chemistry. This compresses downstream process optimization timelines by 60%, drastically accelerating pilot trials.
Transitioning from chlorinated hydrocarbons and petrochemical solvents toward Natural Deep Eutectic Solvents (NADES) and supercritical fluid fractionation. This drastically reduces carbon emissions while delivering 100% solvent-residue-free botanical isolates.
Coupling traditional extraction with targeted enzymatic modification (e.g., glycoside cleavage of ginsenosides to rare Rg3/Rh2 monomers). This hybrid framework unlocks ultra-rare active therapeutic metabolites that naturally occur in biomass at less than 0.01% yield.
A verifiable operational track record partnering with premier pharmaceutical conglomerates, academic research institutes, and university hospitals across China.
Empowering leading market brand-owners through analytical contract research and batch-certified active ingredient supply.
Tongrentang Group
China Resources Sanjiu
Sunflower Pharma
Livzon Pharma Group
Humanwell Healthcare
Yangtzi River Pharma
In-depth insights designed to address critical technical, quality control, regulatory, and intellectual property requirements for global procurement directors.
Direct supply of high-purity single components, monograph standards, and full-chain research solutions for global enterprise procurement.
Submit your target therapeutic indication, required purity threshold, or botanical monomer specification. Our scientific leadership team will prepare a structured feasibility assessment, analytical roadmap, and production timeline within 48 hours.
