In this issue, we examine spray-dried dispersions (SDDs) as an effective method to improve solubility and bioavailability of your active pharmaceutical ingredient (API) in early-phase drug development. We review the spray drying
process, which converts a liquid into a dry powder, and how the resulting SDDs benefit from improved characteristics for further development. We also discuss the combination of spray drying with nanomilling for further bioavailability improvements and flexible downstream processing.
Additionally, we explore the applicability of testing proof-of-concept, as well as creating material for first-in-human (FIH) clinical trials. Leveraging our in-house preclinical services, we also have the unique capability to test spray-dried material versus raw API in vivo, generating meaningful data to compare with in vitro test results.
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In this issue, we examine spray-dried dispersions (SDDs) as an effective method to improve solubility and bioavailability of your active pharmaceutical ingredient (API) in early-phase drug development. We review the spray drying
process, which converts a liquid into a dry powder, and how the resulting SDDs benefit from improved characteristics for further development. We also discuss the combination of spray drying with nanomilling for further bioavailability improvements and flexible downstream processing.
Additionally, we explore the applicability of testing proof-of-concept, as well as creating material for first-in-human (FIH) clinical trials. Leveraging our in-house preclinical services, we also have the unique capability to test spray-dried material versus raw API in vivo, generating meaningful data to compare with in vitro test results.
Issue 41 — Immunomodulation Assessments for Clinical Trials
Altasciences
30 minutes 41 seconds
1 year ago
Issue 41 — Immunomodulation Assessments for Clinical Trials
Immunomodulatory drug development is trending toward increasingly complex modalities as science advances and more effective and safe immunotherapies are needed. Immunomodulatory drugs are at the forefront for the treatment of various types of cancer, infectious diseases, and numerous autoimmune diseases, including rheumatoid arthritis, type I diabetes, lupus, and multiple sclerosis. As the complexity of these therapeutics increases, so must the sophistication of the bioanalytical assays designed to either quantify them or measure their impact on the patient.
In this issue, we review common classes of immunomodulators, bioanalytical methods used to quantify them, and their associated biomarkers. We further present two scenarios that address the complexities of bioanalysis for immunomodulators and practical considerations to ensure quality bioanalysis to inform pharmacokinetic (PK), pharmacodynamic (PD), and safety data in clinical trials.
Altasciences
In this issue, we examine spray-dried dispersions (SDDs) as an effective method to improve solubility and bioavailability of your active pharmaceutical ingredient (API) in early-phase drug development. We review the spray drying
process, which converts a liquid into a dry powder, and how the resulting SDDs benefit from improved characteristics for further development. We also discuss the combination of spray drying with nanomilling for further bioavailability improvements and flexible downstream processing.
Additionally, we explore the applicability of testing proof-of-concept, as well as creating material for first-in-human (FIH) clinical trials. Leveraging our in-house preclinical services, we also have the unique capability to test spray-dried material versus raw API in vivo, generating meaningful data to compare with in vitro test results.
