Monoclonal Antibodies (mAbs) Testing Services
Health Inspired, Quality Driven.
Testing along the mAb process
Engage SGS experts early in your monoclonal antibody program. From discovery through
PK/PD BIOANALYSIS
CELL LINE GENERATION
PROCESS OPTIMIZATION
ENGINEERING RUN
GMP MANUFACTURING
FORMULATION (FILL & FINISH)
CLINICAL STUDIES
monoclonal antibody development process
to market entry, we simplify complexity,
minimize technical and communication barriers, and significantly accelerate regulatory approval.
Our clients can rely on SGS global analytical capabilities and dedicated expertise to accelerate their mAbs project
CELL BANK TESTING • Microbiological • Identity • Viral safety testing • Genetic stability
ANALYTICAL DEVELOPMENT • Methods to monitor critical Quality Attributes
ANALYTICAL DEVELOPMENT • Methods in line with ICH Q14
TRIAL PHASES I, II & III • Biomarker development • Validation of bioanalytical methods
GMP VALIDATION • Methods in line with ICH Q2(R2)
STABILITY TRIALS • Drug Substance • Drug Product
BIOSAFETY
In vitro adventitious virus assays • Endotoxins •
• TEM • Retroviruses detection assays
Mycoplasma (culture + qPCR) • Sterility / Bioburden
Testing for CHO biologics
CHO uBH Characterization Accelerated
CHO uBH Characterization Conventional
Sterility direct inoculation (USP <71>, E.P. 2.6.1)
Sterility direct inoculation (USP <71>, E.P. 2.6.1)
Mycoplasma qPCR
Mycoplasma (USP<63>,E.P. 2.6.7)
28day in vitro (CPE/HAD/HA) 14day assay time based on risk
Risk based panel of degenerate qPCRs
Detection of MVM by qPCR
Detection of MVM by qPCR
Detection and quantitation of C-Type RVLPs by qPCR
Virus particle detection and quantitation by thin section electron microscopy
Biosafety testing of CHO biologics
• Rapid targeted NAT - a fast, ICH Q2-validated alternative to traditional in-vitro assays, accelerating CHO-based biologics manufacturing • Covers 39 qPCR targets across 15+ high-risk viral families (Hsu et al., 2024) for comprehensive detection • Uses TaqMan® chemistry with degenerate primers/probes for broad and specific viral identification, contamination-free and highly sensitive
• Fully aligned with ICH Q5A(R2) guidelines; NGS options available for in-vivo replacement and cell bank testing • Risk-based panel design enabling faster, confident batch release and shorter time to patient
Expert guidance for your analytical strategy
Identify attributes • Identification of attributes
Validate methods • In line with ICH Q2(R2) validation of methods applied to critical Quality Attributes (batch release, stability studies) Trending • Monitoring of method performance • Monitoring of product attributes along its lifecycle
• Product knowledge • Forced degradation Develop method • Adequate selection of technology and instrument • Proof of concept study to confirm methodology Fit-for-purpose • Assessment of analytical procedure performance • Documentation of analytical procedure (including control strategy)
Why SGS: Complete mAbs Project Support
QC & stability (DS, DP, raw materials)
Characterization
Biosafety
Bioanalysis and clinical
STRUCTURAL CHARACTERIZATION • Composition, sequencing, PTMs HIGHER ORDER STRUCTURE • Secondary, tertiary and aggregates FUNCTIONAL CHARACTERIZATION • Ligand binding and cell-based technologies IMPURITY IDENTIFICATION • Product- & process-related impurities
RELEASE TESTING • Compendial, bespoke ID tests • Potency and function MICROBIOLOGY
V IRUS DETECTION ASSAYS • In-vitro, qPCR, TEM CELL IDENTITY & CHARACTERIZATION • DNA fingerprinting, Sanger sequencing GENETIC STABILITY • Southern blot, DNA sequencing (NGS)
ACROSS DRUG DEVELOPMENT PROCESS • From discovery pharmacology to late clinical stages REGULATORY TOXICOLOGY PRECLINICAL AND CLINICAL • Pharmacokinetics (PK) • Immunogenicity (ADA, Nab) • Pharmacodynamics (Cellular/Soluble Biomarkers)
• Sterility, bioburden, endotoxin QUANTITATIVE IMPURITY ANALYSES • Product- and process-related impurities STABILITY TESTING • Accelerated, standard
Expertise for mAbs Producers
SGS Laboratories
Method development, transfer and validation
Biosafety testing
Batch release testing
Characterization studies
+200 TESTS PER DRUG PER YEAR >95% ON TIME DELIVERY
>1200 PHYSICOCHEMICAL TESTS PER YEAR >200 BATCHES TESTED PER YEAR
<4 WEEKS FAST-TRACK METHOD TRANSFER OF EIGHT BIOASSAYS
>50 CHARACTERIZATION PROJECTS TO US FDA & EMA GUIDELINES
Highest quality GMP biosafety testing facility with 72 segregated BSL-2 labs
Our routine batch release and stability studies include physicochemical, potency, purity, microbiological tests
We are experienced in developing complex assays and fast-tracking method transfer
We applied ICH Q6B across diverse studies from insulin to complex biotherapeutic modalities, ensuring compliance with biologics guidelines
Expertise for mAbs Producers
SGS Bioanalysis / Bioequivalence Laboratories
Lab capabilities
Expertise & technologies
Regulatory compliance
5 LABORATORIES (EUROPE, NORTH AMERICA, CHINA) > 600 Projects conducted per year > 2500 Assays developed & validated > 300k Samples analyzed per year > 250 Experts > 35 Years of experience
ALL MODALITIES (NCE, NBE, ADCS, BIOSIMILARS, CGT)
GXP & CFR PART 11 COMPLIANT
• Immuno Assays: Spectramax, MSD, Luminex, Ella™,Cobas, Gyrolab, Wizard • Cell-Based Assays & Molecular Biology: Flow Cytometry, qPCR • LC-MS/MS & LC-UV-Vis/Fluorescence: Sciex, Waters, Shimadzu • Robotic: TECAN & TECAN EVOLizer (TECAN), Andrew (Waters), Extrahera (Biotage)
• US Food and Drug Administration (FDA) • European Medicines Agency (EMA) • UK Medicines and Healthcare products Regulatory Agency (MHRA) • Japan Pharmaceuticals and Medical Devices Agency (PMDA)
Expertise for mAbs Producers
SGS Clinical Pharmacology Unit
Clinical pharmacology unit
Biometrics
Regulatory
Clinical operations
110-BED PURPOSEBUILT EARLY PHASE UNIT
400+ EXPERTS IN DATA MANAGEMENT, BIOSTATISTICS & PK/PD DATA ANALYSIS
SUPPORT FOR CLINICAL TRIAL SUBMISSION & EMA / FDA APPROVALS
GLOBAL CLINICAL RESEARCH / PROJECT MANAGEMENT SERVICES
Extensive experience in biologics and first-in-human trials On-site GMP production facility with 2 QPs
High quality CDISC compliant datasets Ongoing interactive data visualizations
Fastest EU approval timelines for biologic products
Local and international partnerships for patient cohort or ethnic bridging
Monoclonal Antibodies (mAbs) Testing Services
Health Inspired, Quality Driven.
Contact us
pharma@sgs.com sgs.com/pharma sgs.com/linkedinpharma
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