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The elegant design of an antibody-drug conjugate is designated to achieve targeted delivery of the conjugated cytotoxic agents to tumor cells and drug release upon antigen binding and internalization, thus maximizing the antitumor effects while minimizing cytotoxicity to normal tissues. The efficacy of an ADC greatly depends on the specific antigen binding activities of the monoclonal antibody (mAb) portion of the molecule.https://www.creative-biolabs.com/adc/adc-affinity-measurement.htm

ADC Affinity Measurement

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adc adcc

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Development of 5T4-based Bispecific ADCs A bispecific antibody can bind two different targets or two distinct epitopes on the same target. 5T4, specifically overexpressed on the cell surface of various tumors and internalized rapidly when bound to antibody, may be used as an attractive target to develop effective immunotherapy such as bispecific antibody-drug conjugate (ADC). https://www.creative-biolabs.com/adc/development-of-5t4-based-bispecific-adcs.htm

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✔ Clinical overviews (eCTD Module 2.5) including literature review and references ✔ Clinical summaries (eCTD Module 2.7) including clinical pharmacology, efficacy, and safety ✔ Clinical study report preparation and review (eCTD Module 5) ✔ Clinical justification documents for EU, US and other emerging Regulatory markets ✔ Gap analysis for dossiers in clinical module ✔ Clinical and nonclinical document support, handling queries during HA meetings and responding to them ✔ Technical review dossiers ✔ Biowaiver support and justification document services https://www.creative-biolabs.com/immuno-oncology/medical-writing-and-translation.htm

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Drug stability studies are an important part of the drug development and life cycle, especially in support of development and IND submission activities. The stability test assesses how the quality of the drug substance or drug product or its packaging changes over time under the influence of environmental factors including temperature, humidity and light.https://www.creative-biolabs.com/immuno-oncology/stability-analysis.htm

Stability Analysis.pdf

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