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.

​​​​​​Speak with one of our experts to discuss how we can support your program.

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

Four Preclinical Sites to Support Your Program

With four purpose-built preclinical facilities across the U.S., we conduct over 700 safety assessment studies annually in rodent and non-rodent species. Our small and large molecule solutions include pivotal toxicology, safety pharmacology, and PK/PD studies, with comprehensive bioanalytical services to ensure your IND submissions meet global regulatory requirements.

Our specialties include:

Therapeutic Indications

• ophthalmology
• dermatology
• CNS research

Therapeutic Products

• cell and gene therapy
• oligonucleotides
• monoclonal antibodies
• antibody-drug conjugates

Learn more about the specific capabilities provided at each of our preclinical facilities.

Questions on how we can support your drug development program? Consult with one of our experts.

Related resources that may interest you:

• Webpage: Comprehensive Preclinical Drug Development Solutions
• Scientific Article: Navigating the IND Submission Process
• Webinar: How to Select the Right Species for Your Nonclinical Program

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

In this webinar, we dive into the scientific rationale driving species selection and how it can impact your study designs. We also focus on how in vitro species comparison studies can help determine the right species for your in vivo programs.

START WATCHING!

Deciding which animal model to utilize for your preclinical program is not always obvious. Speak with one of our experts who can help identify the appropriate species to generate the most relevant safety data needed to progress your program to Phase I clinical trials.

​​Related resources that may interest you:

• eBook: Navigating the IND Submission Process
• Scientific Poster: Best Practices to Reduce the Number of Animals Used in Toxicology Studies
• Webpage: Comprehensive Preclinical Research Services

Top 10 Life Science Resources

We’ve curated a selection of recently published expert insights, tips, case studies, and scientific and regulatory information, just for you.

1. Webinar:Best Practices to Reduce Animal Use in Toxicology Studies

   Explore the advantages and limitations of various methods for minimizing the number of research animals used in your toxicology studies, while maintaining robust, high-quality, and reproduceable findings. Watch it now.

​​
2. The Altascientist: Issue No. 39 Key Considerations for Nonclinical Dermal Studies—Advancing to Phase I

   Find out more about the nonclinical requirements for moving dermal studies into Phase I clinical trials, including formulation considerations, species selection, and ideal candidates for transdermal drug delivery systems. Read or listen now.



3. Webinar: CNS-Active Compounds—The Importance of Cognitive and Pharmacodynamic Testing During First-in-Human Trials

   Enjoy this comprehensive review of well-known cognitive and pharmacodynamic test batteries, including their applications and limitations in first-in-human studies. Watch the webinar.

4. eBook: Regulatory Comparisons for Starting First-in-Human Clinical Trials

   Delve into the different regulatory requirements, procedures, and timelines based on where you choose to conduct your studies—whether in Canada, the U.S., the UK, or the EU.​​​​​ Read the eBook.



5. Webinar: Nonclinical Adeno-Associated Virus (AAV) Gene Therapy Development

   Explore pre-existing immunity challenges, vector targets, biodistribution, and the role of PCR analysis in assessing therapy efficacy and safety, including case studies highlighting the delicate balance between innovation and regulatory compliance. Watch now.

6. Poster: Sensitive Quantitation of Antisense Oligonucleotides (ASOs)

   Hear about the complex workings of the novel finger-stick-derived capillary collection method, which has recently emerged as an alternative to traditional venipuncture. Watch the poster presentation.



7. Podcast: Successful Manufacturing of Clinical Trial Supply

   Join our formulation and pharmacy experts as they share insider secrets for overcoming clinical trial challenges and resolving issues that could impact your drug development program's timeline. View the podcast.

8. The Altascientist: Issue No. 38 Ensuring Successful Formulation and Drug Product Manufacture for Preclinical Testing

   Uncover the key factors in effective formulation development and manufacturing for safety assessments. Read or listen here.



9. Fact Sheet: Clinical Trial Site Selection and Management

   Learn how we ensure on-time and on-budget completion of your clinical trial projects, and leverage our extensive data and experience to place your study where it makes the most sense, either at one of our clinical sites or at a partner site (or both). ​​Read the fact sheet.

10. Video: Connecting the Dots—So You Don’t Have To

    Discover a simpler drug development journey—one solution seamlessly connecting to the next. Watch the video.

Recent Regulatory Updates:

• FDA: Guidance Draft – Data Integrity for In Vivo Bioavailability and Bioequivalence Studies
• FDA: Guidance Revision – Controlled Correspondence Related to Generic Drug Development
• FDA: Final Guidance – Clinical Pharmacology Considerations for Antibody-Drug Conjugates
• FDA: Guidance Draft – Early Alzheimer’s Disease: Developing Drugs for Treatment
• FDA: Final Guidance – Human Gene Therapy Products Incorporating Human Genome Editing

Reliable Data for Your Unique Needs

We understand that your research needs are unique, and that's why you can trust us to provide data that aligns with your specific requirements.

Part 1 of our video series reveals how our three laboratories, strategically located across North America and unified by mirrored processes, ensure consistent, reliable results.

This underlines our dedication to scientific excellence and seamless synergies.

Watch part 1!

You may also be interested in the following:

• Altasciences Resource Center (scientific publications, eBooks, webinars, and more!)
• Bioanalytical Services
• Preclinical Services
• Clinical Services