Biophysical and Stability Characterization of Antibody-Drug Conjugates

Many standard of care (SOC) treatments in cancer patients result in a clinical outcome of non-response. Drug development companies are trending toward interrogating resistance mechanisms and using this information in advancing their programs and informing personalized approaches to novel therapeutics.

Multiparameter flow cytometry has become an integral tool in the workup of abnormal WBC findings, allowing for rapid and accurate identification of abnormal cell populations, cell lineage assignment, and assessment of clonality. This presentation will discuss a series of cases that demonstrate the utility of flow cytometry in the diagnostic workup of hematologic disorders presenting with abnormal WBC differential and incorporation of relevant criteria from the revised WHO Classification of Tumors of Hematopoietic and Lymphoid Tissues.

Formulators modify the release profiles of drugs for multiple reasons: to target delivery of the API, enhance bioavailability, provide dosage convenience, improve patient adherence, and extend the patentable life cycle of an existing drug.Whether the desired profile is for immediate or modified release, formulators must overcome the development hurdles of poorly soluble APIs. Modified-release drugs may require more excipients and more complex formulations and manufacturing steps, resulting in longer, and more expensive, development processes. Proven formulation methods and careful excipient selection, however, can be employed to develop formulations for modified release drugs that offer value to the patient.

Pharmaceutical manufacturers are facing unprecedented challenges from supply chain disruptions, significant demand fluctuations, reliability.