Case Studies & Whitepapers2025-04-27
Comprehensive Analytical R&D and QC Expertise in Pharmaceutical Development Download
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Case Studies & Whitepapers2025-04-23
Challenges and Advances in CMC Process Development of BsADCs
Antibody drug conjugates (ADCs) have seen significant breakthroughs and reached numerous milestones since 2000 when the first ADC was approved by the FDA and have shown great promise for the treatment of cancer. First generation ADCs were designed to use the affinity of an antibody towards a specific cellular target to bring the cytotoxic payload to the tumor, for example. However, some level of off-target toxicity was often seen with many ADCs because other cellular interactions could occur prior to the payload physically reaching its intended target or the payload could cleave off. These events could lead to unintended death of non-cancerous cells.
Case Studies & Whitepapers2025-03-24
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.
