Leverage Our Truly Integrated Flow Cytometry Solutions

Did you know? Altasciences’ clinical facilities are integrated with state-of-the-art flow cytometry laboratories. We are equipped with advanced platforms and staffed by a dedicated team of in-house experts. With our deep expertise in regulated cellular analysis, our team ensures that every step—from sample collection and processing to transport and analysis—is optimized for precision and speed.

Download our insert on flow cytometry and peripheral blood mononuclear cell (PBMC) isolation to discover:​​​​​​

• when to use flow cytometry in clinical trials;
• the crucial roles of PBMC isolation in clinical trials;
• optimizing flow cytometry analysis with cryopreserved PBMCs; and
• the benefit of our clinical sample kits.

You may also be interested in the following resources:

Videos:
• The True Meaning of Moving in Unison: Clinical and Bioanalytical Solution
• Follow Your Sample From the Clinic to the Lab​​​​​​

Webpages:
• Clinical Research Services
• Bioanalytical Services

In the complex and dynamic field of metabolic drug development, partnering with an accomplished contract research organization is essential.

Altasciences has over 25 years of experience in metabolic diseases and supports every stage of the development process, from the initial discovery phase and preclinical studies to clinical trials and beyond.

Here are a few highlights:

• The teams at our four preclinical sites are proficient in obesity and metabolic models, and both GLP and non-GLP studies in rodents, dogs, minipigs, and NHPs.
• Our clinical teams have completed over 50 early-stage trials involving anti-diabetic and hypoglycemic agents, such as insulin, GLP-1, SGLT-2, and DPP-4, with 75 type I and type II diabetic patients enrolled in a single-center trial over four weeks.
• Our clinical database includes over 400,000 participants to more quickly qualify for inclusion/exclusion criteria based on pre-existing conditions, demographics, medication use, and BMI.
• Our scientists have developed bioanalytical assays for exenatide, glucagon, insulin glargine (M1, M2), insulin aspart, and metformin.
• We can develop additional assays tailored to your program.
• We’ve conducted numerous pharmacodynamics and immunogenicity assessments, including high-glycemic load challenge/tolerance tests, glucose clamps, insulin-induced hypoglycemic events in type 1 diabetes, and anti-drug antibody evaluations.
• We support data management both at our clinics and at external sites.
• Our pharmacokinetic, pharmacodynamic, and statistical experts support the analysis of drug concentration, biomarker, subjective measure, and immunogenicity data.
• Our medical writers and scientists have designed thousands of studies and are accustomed to preparing clinical protocols and high-quality reports.

Ready to get started? Speak with one of our experts.

You may also be interested in the following resources:

• Webpage: Metabolism and Endocrinology
• The Altascientist: The Many Faces of Metabolic Disorders
• Case Study: Concomitant Administration of Multiple Doses of Cagrilintide With Semaglutide 2·4 mg for Weight Management

Timing is Everything

Early collaboration with an experienced CDMO is crucial in drug development to mitigate manufacturing risks and ensure the efficient formulation of your API for preclinical and clinical testing.

For over 25 years, we’ve been providing manufacturing and analytical testing services for solid and liquid dosage forms in most therapeutic areas.

You benefit from:

• optimized processes
• insights into scaling production to reduce costs
• assured regulatory compliance
• accelerated timelines

What's more, our manufacturing site is strategically located near our preclinical and clinical facilities, for seamless transitions from one phase to the next.

Contact us today to discuss the next stage of your drug development journey.

You may also be interested in:

• Infographic: Choosing the Optimal Dosage Form for Your Molecule
• Webinar: Overcoming the Challenges of Manufacturing for Clinical Trials
• eBook: Achieving Optimal Formulation for Preclinical Testing

A New Trend in Early-Phase CNS Trials

Watch this on-demand webinar on which we collaborated with Cambridge Cognition, to learn about the important role of cognitive and pharmacodynamic testing in first-in-human (FIH) trials for novel CNS-active drugs.

Recently, we have seen increasing numbers of complex FIH studies in CNS-active drugs to gather comprehensive data with a wider range of doses as early as possible. Insights in FIH studies provide valuable information on potential dosing, efficacy, and safety, and serve as a good guide for the regulatory requirements needed throughout clinical development.

WATCH THE VIDEO

You may also be interested in these resources:

Webpage:

• CNS Drug Development Solutions

Webinars:

• Inside the Pharmacodynamic Toolbox
• A Review of the FDA's Psychedelic Clinical Research Guidances