Preclinical Research

  • Preclinical Research
  • To You, With Science - Our Latest Audiobook Releases

    Listen to the Latest Audiobook Releases of The Altascientist

    Delve deeper into the critical processes behind early phase drug development with audio versions of The Altascientist, written by our experts with you in mind:

    Issue 31 — The Advantages of Conducting Early Phase Clinical Research in Canada
    Find out you can accelerate your early phase clinical research by six to nine weeks in comparison with trials conducted in the U.S.
    Listen to the audiobook >>>

    Issue 32 — A Changing Paradigm for Non-rodent Species in Nonclinical Safety Studies
    Discover the increasing body of evidence that supports the use of miniature swine as a viable option for your small and large molecule studies.
    Listen to the audiobook >>>​​​

    Issue 33 — CNS Drug Development: Integrated Solutions Lessen Complexity
    Hear about the complexities of CNS drug development programs and how an integrated CRO/CDMO can help move your molecule seamlessly from one phase to the next.
    Listen to the audiobook >>>

     In Case You Missed It: 
    Issue 30 — The Evolution and Advancement of LCMS in Drug Development
    Learn how the latest LC-MS advancements ensure accurate and precise data delivery in your drug development program.
    Listen to the audiobook >>>

    Miniature swine have been widely used for research studies since the 1960s—most commonly within the scope of dermal testing due to similarities of their integument to humans.

    Safety Assessment for Ophthalmic Products

    Explore Our Nonclinical Research Facilities

     

    Altasciences’ North American Nonclinical Research Facilities

    Our nonclinical research facilities include 585,000 square feet of purpose-built space in four strategically placed locations throughout North America. We provide comprehensive regulatory safety testing, bioanalysis, and other research support services for rodent and non-rodent species. Altasciences conducts over 700 safety studies annually, offering a full range of in vivo GLP and non-GLP safety assessments. Our solutions include pivotal toxicology, safety pharmacology, and laboratory services that meet global regulatory requirements for small and large molecules to support your IND, CTA, NDA, or BLA submissions.

    Learn more about our specific capabilities at each of our facilities or consult with one of our experts to discuss your study needs.
     
    EXPLORE OUR FACILITIES

    Have five minutes? Discover our extensive site capabilities:

    •    Webpage: Full Range of Preclinical Drug Development Solutions
    •    Fact Sheet: Preclinical Services Capabilities
    •    The Altascientist: Planning Your Preclinical Assessment

    Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining drug development solutions, whether for a single study or multiple programs, to offer an integrated/synchronized approach to CRO and CDMO services from lead candidate selection to clinical proof of concept, and beyond.

    Don’t Delay Your Study Due to NHP Supply

     

    Altasciences Ensures Nonhuman Primate Availability

    Several preclinical CROs are expecting an impact on study start dates due to nonhuman primate (NHP) supply constraints. NOT Altasciences. We ensure NHP availability! We have the capacity at our four preclinical sites to start your studies six to eight weeks following contracting, thanks to our steady supply of NHPs.

    SCHEDULE YOUR NHP STUDIES TODAY

    At Altasciences, we remove the stress of sourcing research animals so that you can start your studies when you need to, with:

    • Dedicated and diversified cynomolgus monkey supply agreements in place to allow for faster start-up timelines;
    • A continuously maintained and backfilled population of hundreds of naïve NHPs at our preclinical facilities.

    You can schedule newly contracted NHP studies to start immediately.

    Have five minutes? Discover our extensive site capabilities:

    Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining drug development solutions, whether for a single study or multiple programs, to offer an integrated/synchronized approach to CRO and CDMO services from lead candidate selection to clinical proof of concept, and beyond.

    Purpose-Built Facilities for Cell and Gene Therapies

     

    Advanced Early Phase Development Solutions

    Altasciences has a purpose-built facility focused on exploratory and early development research in nonhuman primates (NHPs). Our Sacramento (CA) site, in particular, is dedicated to developing cell and gene therapies, such as adeno-associated virus (AAV) or lentivirus (lenti) products, and applying gene editing technologies like CRISPR/cas9.

    Discover the Altasciences difference:

    •    Extensive in-house capabilities and experience (including historical background data)
    •    Operational experience with infant/juvenile NHPs for long-term studies
    •    Surgery expertise for biopsies, such as in gene editing studies requiring repeated liver sampling
    •    Special necropsy procedures to avoid contamination and ensure the integrity of genomic material in tissues
    •    GLP laboratory in Seattle (WA) to perform qPCR/RT-qPCR of vector and biodistribution and persistence of vector/transgene in tissues

    Consult with one of our experts to discuss your study needs.
     
    SUBMIT AN INQUIRY


    Related resources that may interest you:

    •    Webpage: Full Range of Preclinical Drug Development Solutions
    •    Fact Sheet: Preclinical Services Capabilities
    •    The Altascientist: Planning Your Preclinical Assessment

    Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining drug development solutions, whether for a single study or multiple programs, to offer an integrated/synchronized approach to CRO and CDMO services from lead candidate selection to clinical proof of concept, and beyond.

     

    Expert Support for Your IND/CTA Requirements

    Partnering with Altasciences for your IND/CTA needs will ensure that your application to regulatory agencies moves forward as smoothly and efficiently as possible. To reach your milestones on time, we recommend setting up a meeting to consult with us at least one year before your targeted IND/CTA submission date to allow for program design and ordering of research animals. 

    Contact our experts today

    Altasciences can help you compile the key information necessary to approve your application request, including: 

    • Animal pharmacology and toxicology studies to assess safety; 
    • Manufacturing processes to ensure consistent batches of the study drug; 
    • Clinical protocols and investigator information to assess tolerance and risk. 

    For a more detailed overview of the regulatory planning process, consult our Preclinical Assessment Planning Guide

    You may also be interested in the following: 

    Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining solutions, whether for a single study or multiple programs, to offer an integrated/synchronized approach to CRO and CDMO services.

    Scratching the Surface of Nonclinical Dermal Testing

     

    Altasciences Simplifies Dermal Safety Testing for You

    To bring your molecule from discovery to clinical proof-of-concept and beyond, Altasciences' team of toxicologists and technicians provides a wide range of dermal services. We work with you to develop new or validate existing dermal models, and perform GLP and non-GLP toxicology studies to support both 505(b)(2) and new chemical entity regulatory filings.

    When you partner with Altasciences, you benefit from a CRO who can:

    •    Conduct safety assessments on both small and large molecules
    •    Design and conduct standard and specialty dermal toxicology studies that support your FDA filings
    •    Assess topical therapies using miniature swine and nonhuman primates

    View our eBook on the topic, or consult with one of our experts to discuss your study needs.


    You may also be interested in these related resources:

    •    Webpage: Full Range of Preclinical Drug Development Solutions
    •    Fact Sheet: Preclinical Services Capabilities
    •    The Altascientist: Planning Your Preclinical Assessment
     

    Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining drug development solutions, whether for a single study or multiple programs, to offer an integrated/synchronized approach to CRO and CDMO services from lead candidate selection to clinical proof of concept, and beyond.

    Subscribe to Preclinical Research