Work Supports FDA Filing and Phase I Clinical Testing
Actor Chris Hemsworth, who plays Thor in The Avengers movies among other roles, recently announced that he’s taking a break from acting after learning he has a gene variant that increases his risk of developing Alzheimer’s disease. While the news was not necessarily a surprise because Hemsworth’s grandfather has the disease and it is highly heritable, there is important work to be done to help him and others who may be impacted by the disease in the future. Our work helps with Alzheimer’s drug manufacturing and formulation services to help defeat the disease.
Per the National Institutes of Health’s (NIH) National Institute on Aging, “Alzheimer’s disease is a brain disorder that slowly destroys memory and thinking skills and, eventually, the ability to carry out the simplest tasks. In most people with the disease – those with the late-onset type symptoms first appear in their mid-60s. Early-onset Alzheimer’s occurs between a person’s 30s and mid-60s and is very rare. Alzheimer’s disease is the most common cause of dementia among older adults.”
Today, more than six million Americans are living with Alzheimer’s, impairing their cognitive abilities and impacting their ability to live a long and healthy life. At the direction of NIH’s National Institute of Neurological Disorders and Stroke (NINDS), we are providing drug manufacturing and formulation services of a potent γ-secretase modulator (GSM) drug developed for prevention of early-onset familial Alzheimer’s disease (EOFAD). This drug has demonstrated robust time- and dose-dependent efficacy in acute, subchronic, and chronic studies across multiple species, including primary and secondary prevention studies in a transgenic mouse model. Our work will enable an Investigational New Drug (IND)-filing with the FDA and Phase I clinical testing in 2023.
The scope of activities includes chemistry (process development, chemical scale-up, and current good manufacturing practices [cGMP] active pharmaceutical ingredient [API] manufacturing), analytical, pre-formulation, formulation development, drug product manufacturing, and supply chain/repository services. The work has included developing and validating analytical methods for the API and drug product, cGMP manufacturing of the API (750 g), release testing of the API, stability evaluation of the API and drug product, formulation development of the drug product (API in capsule). The regulated portions of the services (e.g., method validation and manufacturing) follow applicable Food and Drug Administration (FDA) and International Conference on Harmonization (ICH) guidance in order to comply with cGMP regulations (21 CFR Parts 210 and 211).
If successful in clinical testing, this drug could help turn the tide on Alzheimer’s by providing patients with a new option for gaining control over the disease.
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Contact MRIGlobal to further understand our work in pharmaceutical sciences, including the convenience of our centralized repository, biorepository, and foreign trade-zone. We are problem solvers, bringing unique solutions to pharma from drug discovery to manufacturing by providing the necessary testing and analytical chemistry plus materials storage and stability testing. Our service offerings include support for drug substances, drug products, intermediates, and impurities, including reference standard materials.
To learn more about the work we’ve done or how we can help you, contact us today. If you are part of an agency, business, or academic institution seeking assistance with a project, use our Project Quote Tool to get started.
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