GLOBAL ANALYTICAL NETWORK • GERMANY • HONG KONG • BRAZIL • ISO/IEC 17025 ACCREDITED

About Zenith BioChemical Laboratories

Zenith BioChemical Laboratories is an international analytical chemistry and clinical testing network operating ISO/IEC 17025 accredited facilities across Europe (Frankfurt am Main), Asia-Pacific (Hong Kong Science Park), and Latin America (São Paulo), dedicated to uncompromising precision, double-blind verification, and chromatographic excellence.

3 Global Hubs

Germany • HK • Brazil

ISO 17025

Testing Accredited

Double-Blind

100% Impartial Assays

24-48h Rush

Fast-Track Queues

INSTITUTIONAL PROFILE

The Benchmark for Independent Analytical Verification

Founded with the explicit mission to eliminate vendor bias and deliver uncompromised analytical clarity, Zenith BioChemical Laboratories operates as a premier international third-party testing network serving global pharmaceutical companies, biotechnology developers, compounding pharmacies, clinical trial sponsors, and analytical researchers.

Operating across synchronized facilities at Industriepark Höchst (Frankfurt am Main, Germany), Hong Kong Science Park (APAC Hub), and Av. Paulista (São Paulo, Brazil), our network houses an elite fleet of Agilent 1290 Infinity II UHPLC systems, Waters Acquity Premier UPLC systems, Thermo Fisher Scientific Orbitrap High-Resolution Mass Spectrometers (HRMS), Sciex Triple Quad 6500+ LC-MS/MS instruments, and Agilent 7900 ICP-MS elemental analyzers.

TRI-REGIONAL NEXUS

Tri-Regional Global Nexus: Europe, APAC & Latin America

Operating synchronized laboratory hubs in Germany, Hong Kong, and Brazil provides the optimal legal, regulatory, and logistics framework for global analytical verification.

European Hub (Frankfurt am Main)

Located in Industriepark Höchst, our European flagship facility operates under strict German metrological protocols, DAkkS calibration standards (DIN EN ISO/IEC 17025:2017), and direct Frankfurt Airport (FRA) logistics.

APAC Hub (Hong Kong Science Park)

Situated in HKSTP Phase 3, our Asia-Pacific hub leverages English Common Law data protection, free-port customs efficiency, and rapid courier accessioning via Hong Kong International Airport (HKIA).

Latin America Hub (São Paulo)

Positioned on Av. Paulista in São Paulo's biomedical corridor, our LATAM hub provides localized Mercosur sample reception, Brazilian INMETRO/CGCRE alignment, and Portuguese/Spanish client coordination.

Global Cold-Chain Logistics

Coordinated sample intake with temperature-controlled logistics via Lufthansa Cargo, DHL Express, FedEx, and SF Express ensuring sample molecular stability from dispatch to chromatographic run.

FACILITY INFRASTRUCTURE

Tri-Regional Cleanroom Infrastructure (Frankfurt • HK • São Paulo)

ISO Class 7 positive-pressure clean suites and climate-controlled analytical bays deployed across all three network facilities.

ISO 7 / Class 10k

Positive-Pressure Cleanrooms

Dedicated HEPA-filtered clean suites across Frankfurt, HK, and São Paulo for sensitive peptide aliquoting, sterile preparation, and endotoxin assays.

20.0°C ± 0.5°C

Chromatographic Stability

24/7 climate-controlled suites maintaining precise temperature and 45% ± 5% RH for reproducible column retention times across all 3 hubs.

Vibration Dampened

Mass Spectrometry Bays

Sorbothane optical isolation platforms ensuring sub-ppm mass accuracy on Orbitrap HRMS systems in all regional laboratories.

-80°C Cryo Vaults

Nitrogen-Purged Storage

Ultra-low temperature multi-zone specimen repositories across Germany, HK, and Brazil for reference standard longevity and client retention samples.

INSTRUMENTATION FLEET

State-of-the-Art Analytical Fleet

Calibrated daily against NIST, EP, and USP traceable reference standards across Frankfurt, Hong Kong, and São Paulo to guarantee seamless cross-laboratory method transfer.

UHPLC CHROMATOGRAPHY Agilent Technologies

Agilent 1290 Infinity II UHPLC

High-resolution reverse-phase chromatography with sub-2-micron particle columns, quaternary high-pressure binary pumps, and dual-wavelength diode-array detector (DAD) at 214nm and 280nm.

HIGH-RESOLUTION MASS SPEC Thermo Fisher Scientific

Thermo Scientific Orbitrap Exploris

High-resolution exact mass spectrometry (HRMS) with electrospray ionization (ESI) for molecular weight deconvolution, amino acid sequence confirmation, and multivalent charge analysis.

TANDEM MASS SPECTROMETRY AB Sciex

Sciex Triple Quad 6500+ LC-MS/MS

Ultra-sensitive targeted quantitation and multiple reaction monitoring (MRM) for trace synthesis impurities, racemized peptides, and degradation byproducts.

ELEMENTAL IMPURITY SPECTROMETRY Agilent Technologies

Agilent 7900 ICP-MS

Inductively Coupled Plasma Mass Spectrometry for sub-parts-per-billion (ppb) heavy metal screening (Lead, Arsenic, Cadmium, Mercury) conforming to USP <232> / <233> standards.

LEADERSHIP & CHEMISTS

Senior Analytical Leadership

Our global testing operations are directed by senior analytical chemists across Europe, Asia-Pacific, and Latin America with decades of academic and commercial chromatography experience.

Dr. Raymond C.K. Chan, Ph.D.

Chief Analytical Scientist & Head of Chromatography (APAC Hub)

Ph.D. in Analytical Chemistry from HKUST with post-doctoral research at the National Institute of Metrology. Over 18 years of specialized expertise in reverse-phase HPLC peptide separation, column chemistry, and method development.

Dr. Elena V. Rostov, Ph.D.

Principal Mass Spectrometrist & Structural Lead (European Hub)

Ph.D. in Biophysical Chemistry from ETH Zürich. Former senior spectral analyst at European reference laboratories in Frankfurt, specializing in Orbitrap high-resolution mass spectrometry and deconvolution of complex peptide conjugates.

Marcus Leung, M.Sc., CChem

Director of Quality Assurance & Global Accreditations

Chartered Chemist (MRSC) and certified ISO/IEC 17025 Lead Assessor. Oversees tri-regional quality harmonization across DAkkS, HKAS, and INMETRO/CGCRE accreditations and dual-chemist sign-off procedures.

Dr. Lucas Silva Mendes, Ph.D.

Head of Bio-Safety & Regional Operations (LATAM Hub)

Ph.D. in Bio-Organic Chemistry from Universidade de São Paulo (USP) with research at the Max Planck Institute. Specializes in ICP-MS elemental impurity quantitation, endotoxin (LAL) testing, and Mercosur regulatory validation.

ACCREDITATIONS & CERTIFICATIONS

Tri-Regional Accreditation & Standards Framework

Our laboratory network adheres strictly to international metrological and diagnostic benchmarks, audited independently by leading German, Hong Kong, Brazilian, and international accreditation bodies.

DAkkS Germany DIN EN ISO/IEC 17025:2017

HOKLAS Lab #0842 HKAS Chemical Testing

INMETRO / CGCRE Brazilian Standard Accreditation

ISO 15189:2022 Medical Laboratory Diagnostics

ISO/IEC 27001:2022 Bureau Veritas Information Security

ILAC-MRA International Mutual Recognition

GLOBAL HUBS

Tri-Regional Facilities & Sample Reception

Direct physical reception desks and priority intake channels across Europe, Asia-Pacific, and Latin America.

EUROPEAN HUB DAkkS ACCREDITED

Germany • Frankfurt am Main

Location: Industriepark Höchst, Building G830, 65926 Frankfurt am Main, Germany
Transit: S-Bahn S1/S2 Frankfurt Höchst • 15 mins to Frankfurt Airport (FRA) CargoCenter
Hours: Mon – Fri: 08:30 – 17:30 CET (UTC+1)
Hotline: +49 69 305 84210
Email: [email protected]

APAC HUB HOKLAS #0842

Hong Kong • Science Park

Location: Units 301, 3/F, Building 2A, Phase 3, Hong Kong Science Park, Pak Shek Kok, NT, Hong Kong
Transit: MTR University / Sha Tin → Science Park Shuttle / KMB 272K
Hours: Mon – Fri: 08:30 – 18:30 HKT (UTC+8)
Hotline: +852 2334 5581
Email: [email protected]

LATIN AMERICA HUB INMETRO ALIGNED

Brazil • São Paulo

Location: Av. Paulista, 1374, 11º andar - Bela Vista, São Paulo - SP, 01310-100, Brazil
Transit: Metrô Linha 2-Verde (Trianon-Masp) • Priority Sedex/DHL Intake
Hours: Seg – Sex: 08:30 – 17:30 BRT (UTC-3)
Hotline: +55 11 3195 6280
Email: [email protected]

Central Administration & Global Coordination

General: [email protected] • Intake: [email protected] • Compliance: [email protected]

ISO 27001 Encrypted Portal: End-to-end data encryption across all hubs.