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.

In this issue, we explore the characteristics and advantages of non-GLP discovery studies, along with emerging trends in this important early phase of drug development research. We also present two case studies from our Sacramento site, highlighting discovery studies that assessed the biodistribution of the test article under specific experimental conditions.

In this issue of The Altascientist, we review strategies, including those implemented at Altasciences, for developing, qualifying, and implementing CRAs to assess the safety of test articles in vitro to complement in vivo preclinical safety assessment.

According to the World Health Organization, at least a billion people are currently living with vision impairment from a preventable or treatable source. The main conditions causing their distance vision impairment or blindness are cataracts, refractive error, age-related macular degeneration, glaucoma, diabetic retinopathy, and presbyopia. Precedence Research reports that the global ophthalmic drug market size is estimated to double in 10 years, from $34.6 billion in 2021 to an estimated $68.93 billion by 2030. The development of pharmacological interventions for many of these conditions has been accelerating, supported by new delivery methods and formulation approaches. For conditions that require surgery or corrective devices, eye drops are an important part of diagnosis, and pre- and post-surgery treatment plans. In this issue of The Altascientist, we explore how to meet the challenges of formulation development for ocular therapies.

Current and future development of glucagon-like peptide-1 receptor agonists, more commonly referred to as GLP-1 RAs, or simply as GLP-1s, involves complexities not only in formulation but in all areas of early-phase drug development. Developing and refining preclinical models for early efficacy signals, developing and validating the bioanalytical assays necessary for quantitation, and designing the clinical studies that deliver the most robust data in this innovative therapeutic area are all key elements of a drug development program. In this audiobook, we review the requirements for successful GLP-1 drug development, from the perspective of preclinical studies, clinical trials, manufacturing, and bioanalysis. Exclusive case studies are also presented.

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.