cGMP Manufacturing
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In the United States, the Current Good Manufacturing Practice (cGMP) is the Food and Drug Administration (FDA) 's formal regulations on the design, monitoring, control and maintenance of manufacturing processes and facilities.https://www.creative-biolabs.com/immuno-oncology/cgmp-manufacturing.htm
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ADC conjugate sites analysis
Antibody-drug conjugates employ the specific monoclonal antibodies (mAbs) to achieve targeted delivery of the conjugated cytotoxic molecules to tumor cells.
https://www.creative-biolabs.com/adc/conjugate-sites-analysis.htm
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While conventional cancer therapies (surgery, chemo therapy, and radiation therapy) have shown some success in the battle again cancer, they are often accompanied by complex and sometimes, severe side-effects due to the lack of target specificity. To circumvent this flaw and improve the efficacy and safety of cancer treatment, targeted cancer therapies, especially antibody-drug conjugates (ADCs), have been actively exploited and they are gaining a significant amount of attention during the recent years.https://www.creative-biolabs.com/adc/adc-antibody-screening.htm
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Antibody-drug conjugates employ the specific monoclonal antibodies (mAbs) to achieve targeted delivery of the conjugated cytotoxic molecules to tumor cells.
https://www.creative-biolabs.com/adc/conjugate-sites-analysis.htm
adc chemistry
As one major component of an antibody-drug conjugate (ADC), the antibody is the key for target specificity and serves as the cargo to deliver the cytotoxic drug (payload).
https://www.creative-biolabs.com/adc/antibody-design-and-conjugation.htm
ADC Biotechnology
To retain antibody bioactivity, mild, near-physiological conditions are often used for conjugation reactions. Under these conditions, endogenous amino acids such as Lys and Cys are chemically reactive and can be used as conjugation sites.https://www.creative-biolabs.com/adc/antibody-design-and-conjugation.htm
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As one major component of an antibody-drug conjugate (ADC), the antibody is the key for target specificity and serves as the cargo to deliver the cytotoxic drug (payload). A payload drug can be attached to different sites on an antibody using diverse conjugation chemistry. Multiple endogenous amino acids can serve as potential conjugation sites. However, to achieve more precisely controlled site-directed conjugations and subsequently a narrower distribution of drug-to-antibody ratio (DAR), special moieties with unique conjugation chemistries are engineered into antibody sequences in our antibody design services.
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adc cd40
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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
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https://www.creative-biolabs.com/immuno-oncology/ind-publishing-and-submission.htm
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Antibody and Protein Pharmacology
Pharmacology is a key component concerned with the study of drug action in animal models which is essential and determinant to IND approval and ultimate NDA approval for a drug candidate. https://www.creative-biolabs.com/immuno-oncology/antibody-and-protein-pharmacology.htm
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✔ Registration with CTSC
✔ Preparing IND package including Cover letter, IND, 1571, 1572 form and certification form 3674.
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https://www.creative-biolabs.com/immuno-oncology/ind-publishing-and-submission.htm
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