Preformulation Strategy- Inception to Completion

Drug discovery is an exceedingly complex process. Discovering a new chemical entity is in itself a huge accomplishment, which is often possible only after almost two decades of hard experimental work as well as advanced simulation efforts. Therefore, the next stage of the process, determination of toxicity becomes even more crucial as most new chemical entities (NCE) are disqualified if the NCE shows a potential toxic effect, despite any possible therapeutic effect.

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Efficacy and Safety - Guidelines for Clinical In-use Stability Studies of ADCs

Antibody-drug conjugates (ADCs) consist of three parts: antibody, linker, and payload. This special combination enables ADCs to selectively target tumor cells and release cytotoxic drugs, but they face many stability challenges during manufacture, storage, and clinical use. In this paper, the drug product development team at Porton (hereinafter referred to as "we") discusses the necessary clinical in-use stability studies for ADCs.

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Molecular Modeling and Data Science for De-risking and Cost- saving of Pharmaceutical Development

Molecular Modeling and Data Science for De-risking and Cost- saving of Pharmaceutical Development

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Overview and Case Study of Antibody Oligonucleotide Conjugates (AOC)

In the field of biomedical science, technological changes are common and constantly evolving. In recent years, antibody oligonucleotide conjugates (AOCs) have attracted considerable attention in the industry as an innovative and advanced biomedical method, and more and more domestic and foreign biopharmaceutical companies have participated in the research and application of AOCs. Because AOC combines the advantages of oligonucleotide technology and antibodies, it is considered to have the potential to provide precise targeted therapy and is expected to bring about a revolution in the biomedical field.

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An ADC's Path to Market-Analysis of Difficulties and Key Points in ADC Process Scale up

An Antibody-Drug Conjugate (ADC) is a novel therapeutic agent which can deliver a highly-potent traditional small molecule drug to a specific site or cell within the body. It is formed when an active drug (the payload) is connected to an antibody using a linker. The complex is referred to as an ADC and it uses the cellular specificity of antibodies to direct the payload and deliver to the active disease site within the cell. This enables ADCs to selectively treat cancer cells, tumor microenvironments, or other target cells, while reducing systemic, off-target toxicity. This targeted delivery of ADC agents has shown great promise and explosive growth in recent years.

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