Antibody-drug Conjugates Production
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Antibody-drug conjugates (ADCs) are a class of novel APIs with high potency. Our experienced scientists and technicians can provide comprehensive custom services to develop numerous ADC products for every stage of development, from antibody expression to cGMP manufacturing.https://www.creativebiolabs.net/antibody-drug-conjugates-production.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
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
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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
Antibody Design and Conjugation
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.
https://www.creative-biolabs.com/adc/antibody-design-and-conjugation.htm
adc cd40
CD40, also known as TNFRSF5, is a type I transmembrane protein. The molecular weight of CD40 is 48-kDa and it consists of a 193 amino acid (aa) extracellular domain, 21 aa leader sequence, 22 aa transmembrane domain, and a 62 aa intracellular domain in human (90 aa in mouse).https://www.creative-biolabs.com/adc/target-cd40-122.htm
ADC Biochemical Analysis
ADC preparation involves the chemical conjugation of the three components and depending on the conjugation strategy used, this process often yields complex and heterogeneous products.https://www.creative-biolabs.com/adc/adc-biochemical-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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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
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
Antibody Design and Conjugation
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.
https://www.creative-biolabs.com/adc/antibody-design-and-conjugation.htm
adc cd40
CD40, also known as TNFRSF5, is a type I transmembrane protein. The molecular weight of CD40 is 48-kDa and it consists of a 193 amino acid (aa) extracellular domain, 21 aa leader sequence, 22 aa transmembrane domain, and a 62 aa intracellular domain in human (90 aa in mouse).https://www.creative-biolabs.com/adc/target-cd40-122.htm
ADC Biochemical Analysis
ADC preparation involves the chemical conjugation of the three components and depending on the conjugation strategy used, this process often yields complex and heterogeneous products.https://www.creative-biolabs.com/adc/adc-biochemical-analysis.htm
ADC Antibody Screening
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
ADC Affinity Measurement
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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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).
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✔ Preparing IND package including Cover letter, IND, 1571, 1572 form and certification form 3674.
✔ Assembling and binding volumes
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https://www.creative-biolabs.com/immuno-oncology/ind-publishing-and-submission.htm
Pre-IND Meeting
For the drug development, pre-IND meeting is a critical tool to discuss the needs and challenges specific to the general product development, nonclinical testing, manufacturing information, protocol design or other regulatory questions defined in the Code of Federal Regulations (21 CFR 312.82). https://www.creative-biolabs.com/immuno-oncology/pre-ind-meeting.htm
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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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With the rapid progress of various immunotherapies, especially the therapeutic antibodies, the discovery and development of potential anticancer immunotherapy approaches has become a promising direction. https://www.creative-biolabs.com/immuno-oncology/efficacy-models.htm
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✔ Preparing IND package including Cover letter, IND, 1571, 1572 form and certification form 3674.
✔ Assembling and binding volumes
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For the drug development, pre-IND meeting is a critical tool to discuss the needs and challenges specific to the general product development, nonclinical testing, manufacturing information, protocol design or other regulatory questions defined in the Code of Federal Regulations (21 CFR 312.82). https://www.creative-biolabs.com/immuno-oncology/pre-ind-meeting.htm
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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/adc/development-of-5t4-based-bispecific-adcs.htm
IND Publishing and Submission
✔ Registration with CTSC
✔ Preparing IND package including Cover letter, IND, 1571, 1572 form and certification form 3674.
✔ Assembling and binding volumes
✔ Submission
https://www.creative-biolabs.com/immuno-oncology/ind-publishing-and-submission.htm
Pre-IND Meeting
For the drug development, pre-IND meeting is a critical tool to discuss the needs and challenges specific to the general product development, nonclinical testing, manufacturing information, protocol design or other regulatory questions defined in the Code of Federal Regulations (21 CFR 312.82). https://www.creative-biolabs.com/immuno-oncology/pre-ind-meeting.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
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✔ Clinical justification documents for EU, US and other emerging Regulatory markets
✔ Gap analysis for dossiers in clinical module
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✔ Biowaiver support and justification document services
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To gain approval for clinical testing after finalizing the pre-clinical testing of innovative new therapies, it is a key milestone for pharmaceutical companies to apply for approval of Investigational New Drug (IND) with FDA or other agencies.https://www.creative-biolabs.com/immuno-oncology/regulatory-strategy-consulting.htm
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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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Pre-clinical toxicology is a study of the toxic effects of drugs in development based on statistical and quantitative analysis. https://www.creative-biolabs.com/immuno-oncology/antibody-and-protein-toxicology.htm
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
Efficacy Models
With the rapid progress of various immunotherapies, especially the therapeutic antibodies, the discovery and development of potential anticancer immunotherapy approaches has become a promising direction. https://www.creative-biolabs.com/immuno-oncology/efficacy-models.htm
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Drug discovery and development pathway is a long journey, and complications and inefficiencies at the late stage can create costly delays. Therefore, safety and efficacy profiles assessments of drug candidates prior to clinical trials are critical stages to avoid unnecessary loss. Preclinical testing in animal models can help to foreseen potential risks of drug candidates before exposure to humans, and hence reduce the cost for pharmaceutical industries and help to make the appropriate choice.https://www.creative-biolabs.com/immuno-oncology/preclinical-testing.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
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Cancer immunotherapy is a therapy used to treat cancer patients that involves components of the immune system, commonly consisting of antibodies, vaccines, T cell infusions, and so like.https://www.creative-biolabs.com/immuno-oncology/modality.htm
IND Publishing and Submission.pdf
✔ Registration with CTSC
✔ Preparing IND package including Cover letter, IND, 1571, 1572 form and certification form 3674.
✔ Assembling and binding volumes
✔ Submission
https://www.creative-biolabs.com/immuno-oncology/ind-publishing-and-submission.htm
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For the drug development, pre-IND meeting is a critical tool to discuss the needs and challenges specific to the general product development, nonclinical testing, manufacturing information, protocol design or other regulatory questions defined in the Code of Federal Regulations (21 CFR 312.82). https://www.creative-biolabs.com/immuno-oncology/pre-ind-meeting.htm
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Regulatory medical writing and translation plays an important role for the regulatory submission documents during the drug development process and defines the success of novel pharmaceutical products. https://www.creative-biolabs.com/immuno-oncology/medical-writing-and-translation.htm
Regulatory Strategy Consulting.pdf
To gain approval for clinical testing after finalizing the pre-clinical testing of innovative new therapies, it is a key milestone for pharmaceutical companies to apply for approval of Investigational New Drug (IND) with FDA or other agencies. https://www.creative-biolabs.com/immuno-oncology/regulatory-strategy-consulting.htm
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