GMP Manufacturing of Antibody-Drug Conjugates (ADC)
At GTP Bioways, we specialize in GMP ADC manufacturing, offering comprehensive bioconjugation services for antibody-drug conjugate (ADC) manufacturing, from process development through CMC and analytical release.
Our GMP bioconjugation services
At GTP Bioways, our GMP bioconjugation services are designed to meet the rigorous quality standards demanded by the biopharmaceutical industry. Leveraging state-of-the-art facilities and robust standard operating procedures, we perform site-specific antibody conjugations to ensure batch-to-batch consistency, high payload homogeneity, and optimal thermal stability.
Our expertise spans a wide range of linker chemistries (e.g., maleimide, engineered cysteine, enzymatic) and payload classes (small molecules, toxins, radionuclides), enabling you to select the conjugation strategy best suited to your potent molecule.
With end-to-end documentation, advanced analytics, and dedicated project management, GTP Bioways’ GMP bioconjugation services provide a turnkey solution for accelerating your ADC candidates from concept to clinic.
Dedicated GMP conjugation for cytotoxic payloads
GTP Bioways’ cGMP production suite is engineered for safe, compliant ADC manufacture at up to 100 L scale, with specialized containment and documentation to meet FDA, EMA, and PMDA standards.
OEB6 Isolator Technology: Fully enclosed systems for handling highly potent APIs (HPAPIs/eHPAPIs) without cross-contamination.
Stainless-Steel Bioreactor: Precise control of temperature, mixing, and pH ensures consistent DAR and batch reproducibility.
Single-Use Purification: Disposable chromatography and TFF modules accelerate turnaround and eliminate cleaning validation.
CFR-Compliant Quality System: Comprehensive batch records, deviation tracking, and change control for audit readiness.
This streamlined platform delivers scalable, secure GMP conjugation services for your most potent cytotoxic payloads.
Streamline your ADC production with our comprehensive development & manufacturing services
With our unmatched expertise and capabilities, we seamlessly cover every stage of your antibody drug conjugate project, from antibody intermediate production to bioconjugation and GMP manufacturing of drug substance and drug product.
Analytical characterization of ADC
Robust analytical characterization is critical to ensure safety, efficacy, and regulatory approval of antibody-drug conjugates. GTP Bioways offers a full suite of CMC-driven analytical services, all performed in a GLP-compliant lab staffed by high-level scientists. Our offerings include:
Drug-Antibody Ratio (DAR) & Residual Free Drug: Precise quantification of conjugated payload and unbound toxin to ensure target DAR and minimal free-drug carryover.
Fragment Profile by Size-Exclusion Chromatography (SEC): Assessment of aggregation and fragmentation to confirm molecule integrity.
Micro-Flow Imaging: High-resolution particle counting and visualization for subvisible particle analysis.
Cytotoxicity Bioassays: Cell-based potency testing to validate functional activity post-conjugation.
Residual Solvent Analysis: Trace detection of process solvents via GC–MS to meet ICH guidelines.
Mass Spectrometry: Intact and peptide-level MS for detailed characterization, DAR confirmation, and batch-release documentation.
Our experienced analytical team delivers actionable data on ADC purity, potency, and safety through comprehensive method development, transfer, and validation—ensuring a robust workflow that de-risks your development path, streamlines regulatory review, and underpins the successful cGMP manufacturing of your bioconjugate drug substance and drug product.
Regulatory compliance & quality assurance
At every stage of ADC manufacturing, GTP Bioways maintains the highest quality and compliance standards to safeguard patient safety and product integrity. Our Quality Management System encompasses:
GMP-Compliant Documentation: complete batch records, deviations, CAPA, and change control
Quality Risk Management: FMEA, risk-based release testing, and environmental monitoring
Regulatory Support: CMC section authoring for IND, CTA, and BLA filings in EU, US, and Rest of World markets
Audits & Inspections: ready for FDA, EMA, PMDA, and other regulatory body inspections with transparent data access
Partner with us for a seamless GMP ADC manufacturing journey backed by proactive quality oversight and expert regulatory guidance.
FAQ on GMP ADC Manufacturing & Bioconjugation Services
What are the key benefits of antibody-drug conjugates in therapeutic development?
Antibody-drug conjugates (ADCs) harness the targeting precision of monoclonal antibodies to deliver highly potent cytotoxic payloads directly to tumor cells, significantly reducing off-target effects and systemic toxicity. This targeted approach often translates into higher therapeutic indices and improved patient tolerability. At GTP Bioways, we support ADC innovation from early linker design through full cGMP manufacturing, ensuring each conjugate achieves optimal stability, efficacy, and safety for clinical success.
What bioconjugation and GMP ADC manufacturing services does GTP Bioways offer?
We provide end-to-end ADC services, including site-specific conjugation using maleimide, engineered cysteine, or enzymatic linkers; scale-up protocols from milligram R&D runs to 100 L clinical batches; OEB6 isolator technology for safe HPAPI/eHPAPI handling; both stainless-steel and single-use downstream purification (chromatography & TFF); and comprehensive documentation per 21 CFR Part 210/211. Each project benefits from tailored process optimization, tech-transfer support, and real-time project management to keep timelines on track.
How does GTP Bioways ensure GMP compliance and high-quality ADC manufacturing?
Our cGMP production suites are ISO-certified and audited to FDA, EMA & PMDA standards. We enforce rigorous SOPs, FMEA-based risk assessments, environmental monitoring, CAPA workflows and change control—delivering audit-ready batch records and consistent product quality.
What analytical and CMC support does GTP Bioways provide for ADCs?
In our GLP-compliant labs, we offer a comprehensive CMC package: DAR and residual free-drug quantification; fragment profiling by SEC; subvisible particle analysis via micro-flow imaging; functional cytotoxicity bioassays; residual solvent testing by GC-MS; and intact-/peptide-level mass spectrometry for detailed characterization and batch release. We also specialize in analytical method development, transfer, and validation, ensuring your regulatory submissions are backed by rigorous data.
How do you determine and control Drug-Antibody Ratio (DAR) and residual free drug?
DAR is initially measured by hydrophobic interaction chromatography (HIC) and then confirmed with high-resolution intact mass spectrometry. We fine-tune conjugation parameters—such as antibody reduction level, linker stoichiometry, and reaction time—in our controlled bioreactor environment to achieve your target DAR. Post-conjugation, we run batch-release assays to quantify any unbound payload, ensuring free-drug levels remain below critical safety thresholds.
What containment technologies are used for cytotoxic payloads in ADC production?
We utilize OEB6 isolator technology—the highest current containment standard—to protect operators and the environment when handling HPAPIs and eHPAPIs. Our isolators feature negative-pressure cascade control, HEPA-filtered exhaust, and glove-box interfaces, eliminating cross-contamination risks and ensuring payload integrity throughout conjugation steps.
Can GTP Bioways scale and customize ADC manufacturing processes?
Absolutely. Our flexible platform spans 1 L–100 L conjugation reactors and 10 L–200 L single-use downstream systems, with validated scale-up into 200 L–2 000 L GMP suites. We customize linkers, payload chemistry, and process parameters based on your molecule’s properties, and provide full tech-transfer packages—including batch records, SOPs, and on-site support—to ensure a smooth transition to larger scales.
How does ADC process development integrate with clinical trial phases?
From preclinical proof-of-concept through Phase I/II/III, we align conjugation and manufacturing milestones with your clinical timelines. We supply GMP-grade clinical trial material, conduct stability studies under ICH conditions, and generate CMC documentation to support IND, CTA, and BLA filings. Our collaborative approach ensures that each regulatory submission is backed by robust data and that manufacturing readiness keeps pace with your trial progression.
Discover our comprehensive range of development and manufacturing services meticulously tailored to match your unique requirements.
Connect with us now to embark on an exciting journey for your bioconjugate development and clinical supply!
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