◆ Pharmacokinetic Evaluation System — Macromolecular Drug Bioanalysis Platform
● Platform Introduction
Lewwin’s macromolecule bioanalytical platform operates under internationally aligned bioanalytical technology and quality-assurance systems; the platform laboratories are equipped with ultra-sensitive multiplex electrochemiluminescence analyzers, flow cytometers, high-throughput quantitative PCR systems, automated nucleic-acid extractors, gel-imaging systems, ELISpot readers, multifunctional microplate readers, LC-MS/MS systems, and other instruments. The platform provides pharmacokinetic/toxicokinetic studies for all types of biologics and advanced therapeutic medicinal products, clinical and non-clinical biosample testing, immunogenicity research, and molecular-biology detection services.
● Bioanalytical Testing Services (Clinical & Non-clinical)
Assay development and validation
LC-MS/MS quantitative analysis of peptides, nucleic acids, and PROTAC drugs
ELISA quantitative analysis of protein and antibody therapeutics
MSD quantitative analysis of protein and antibody therapeutics
qPCR quantitative analysis of advanced therapy medicinal products
FACS quantitative analysis of cell-based therapeutics
In-vivo imaging and immunofluorescence analysis of cell-based therapeutics
Pharmacokinetic & Toxicokinetic Research Services
Single-/multiple-dose pharmacokinetics
Tissue-distribution/biodistribution studies
Toxicokinetics accompanying repeat-dose studies
Molecular Biology Testing Services
Assay development and sample testing: flow cytometry, ELISA, MSD, and qPCR
Cellular immunophenotyping
Mouse, rat, rabbit, guinea pig, dog, and monkey
Lymphocyte-subset detection (CD3+, CD4+, CD8+), B-lymphocyte counting (CD45+, CD20+), macrophage counting (M1 and M2 types), NK-cell counting (CD16+, CD56+), etc.
Multiplex cytokine detection: flow-cytometry CBA, MSD, and ELISpot
Humoral immunity analysis: immunoglobulins (IgA/IgE/IgG/IgM), complement C3/C4/C5/C5a, and specific antibody detection and assay development
Cell-product quality-control testing: FDA, EMA, and Pharmacopoeia of the People’s Republic of China
Immunogenicity Research Services
Anti-drug antibody testing: screening, confirmation, and titer assay
Neutralizing antibody testing
Ligand-binding assay (LBA)-based detection technology
Cell-based assay (CBA)-based detection technology
● Equipment (Partial)
● Platform Qualifications and Certifications
Three invention patent applications for testing technologies filed, all of which have entered substantive examination, with one already granted.
Successfully passed the proficiency tests organized by the National Institutes for Food and Drug Control in 2019, 2021, 2022, and 2023.
◆ Pharmacokinetic Evaluation System — Small Molecule Drug Bioanalysis Platform
● Platform Introduction
Lewwin Pharm Small Molecule Bioanalysis Platform is based on a GLP management system and possesses comprehensive certification qualifications and a strict quality management system. Certifications include NMPA GLP certification, OECD GLP certification, CNAS laboratory accreditation, China National Institute for Food and Drug Control proficiency test certificates, etc. The platform laboratories are equipped with multiple models of liquid chromatography-mass spectrometry systems (Waters, AB Sciex), gas chromatography-mass spectrometers, high-resolution mass spectrometers, and other instruments, covering non-clinical and clinical biological sample analysis and testing. Lewwin Pharm offers bioanalysis services from early screening to the new drug application stage.
● Main Services (Supporting submissions for China, USA, and EU)
Non-clinical Pharmacokinetic and Toxicokinetic Biological Sample Testing Services
Bioanalytical method development and validation (multiple species, multiple matrices)
Compound screening DMPK research
Regulatory and non-regulatory in vitro pharmacokinetic studies (liver microsome/hepatocyte/hepatic S9 metabolic stability and metabolite identification studies, metabolic phenotyping studies, CYP enzyme inhibition/induction studies, plasma protein binding rate, Caco-2 permeability assays, melanin binding assays, in vitro transdermal absorption)
Regulatory and non-regulatory in vivo pharmacokinetic studies (absorption and plasma concentration-time curve studies, tissue distribution studies, metabolite identification and quantitative analysis, excretion studies, bioequivalence studies, interaction studies, blood-brain (cerebrospinal fluid) barrier permeability studies)
Toxicokinetic studies (repeated-dose toxicity studies, reproductive toxicity studies, carcinogenicity studies, etc.)
● Bioanalytical Method Development and Validation
Quantitative analysis of small molecules, PTOTAC drugs, peptides, small nucleic acids, etc. by UPLC-MS/MS methods
Quantitative analysis of chiral drugs by UPCC-MS/MS methods
Component analysis, metabolite identification, and protein characterization by UPLC-Vion Qtof methods
Metal element analysis by ICP-MS methods
In vivo and in vitro drug analysis by GC-FID/MS methods
In vivo and in vitro drug analysis by HPLC/UPLC-UV/ELSD/RID methods
● Instruments and Equipment (Partial Listing)
● Project Experience
We have established analytical methods for over 500 drug molecules, and all projects have passed review.
Bioanalytical determination of endogenous substances, ultra-low drug concentration analysis, multi-analyte analysis, complex matrix sample analysis.
Full-process biological sample testing for innovative drugs, from early drug screening to new drug application.
Biological sample testing for ophthalmic drugs/chiral drugs/prodrugs.
Biological sample testing for special formulations (micelles, liposomes, microspheres, etc.).
Biological sample testing for transdermal/inhalation/mucosal/intra-articular/intranasal dose formulations.
● Proficiency Test Certificates
Passed the CFDA GLP certification inspection in January 2016 and passed the periodic certification inspections in 2019 and 2022.
Obtained CNAS laboratory accreditation in 2024. This marks that the platform’s analytical capabilities possess higher authority and credibility.
Passed the proficiency tests conducted by the National Institutes for Food and Drug Control (NIFDC) in 2019, 2021, 2022, and 2023.
● Capabilities & Competencies – Patents for Inventions
Applied for 7 invention patents related to testing and analysis technologies, all of which have entered the substantive examination stage.
4 patents have been granted.
