Preclinical Research

  • Preclinical Research
  • [NEW EBOOK] Safety Assessment for Ophthalmic Products

     

    Excellence in Ophthalmic Safety Testing

    Altasciences has been conducting ophthalmic safety testing for decades, with all global regulatory submissions from our studies approved for design, conduct, and data integrity. We perform ocular pharmacokinetic studies in multiple species (rodent and non-rodent), using different types of formulations and routes of administration, and support study durations ranging from single-dose acute to studies of six and nine months.

    Learn more about our early phase ophthalmic drug development expertise in our latest eBook.
     
    VIEW EBOOK

    Do you have an ocular drug compound in your development pipeline?
    Speak with one of our experts about your study or end-to-end, preclinical to clinical proof-of-concept program. Let’s get you started!

    Related resources that may interest you:

    The Altascientist: The Complexities of Early Phase Ophthalmic Drug Development
    Fact Sheet: Comprehensive Services for Ophthalmic Drug Development

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    You have questions; we have answers.

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    Altasciences
     

    When you need quick answers to your burning questions, simply ask an Altascientist.   

    Chris McEvoy


    How does Altasciences expedite the process for acquiring CITES permits?  
    Watch the video »
    Connect with Chris »

    Scott Boley


    What are the advantages of selecting the miniature swine as a non-rodent model?
    Watch the video »
    Connect with Scott »

    Mathieu Saulnier


    Why is it important to have an in-house team dedicated to bioanalytical equipment?
    Watch the video »
    Connect with Mathieu »

    Lisa Sanford


    Do I need an IND before starting my FIH trial in Canada?
    Watch the video »
    Connect with Lisa »

    Roland Jbeily


    What should sponsors know about Canada’s regulatory requirements for CTA filings?
    Watch the video »
    Connect with Roland »

    Scott Boley


    What factors should sponsors consider when selecting a non-rodent alternative in their nonclinical studies?
    Watch the video »
    Connect with Scott »

    Ben Reed


    What do the recent expansions to Altasciences’ CDMO facility mean for current and future clients?
    Watch the video »
    Connect with Ben »

    Dennis DiBiagio


    How does Altasciences’ manufacturing site support the development of drugs that treat CNS disorders?
    Watch the video »
    Connect with Dennis »

    Submit a question
    See full video series

    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.
     

    Altasciences has been recognized as a 2023 CRO Leadership Award Champion in the Capabilities category, as voted by you in ISR’s annual CRO Quality Benchmarking survey.

      



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    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.

     

    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.

    How Miniature Swine Models Are Revolutionizing Preclinical Research

     

    More Models, More Options

    The miniature swine has emerged as a viable non-rodent alternative for nonclinical studies. Our team has extensive experience with miniature swine in several therapeutic areas, including dermal, cardiovascular, metabolic diseases, inflammation, and wound healing.

    Want to explore this promising option further?

    DISCOVER MORE
     

    You may also be interested in the following:

    Webinars:
    - Miniature Swine Model Selection Criteria for Toxicology and Pharmacology Studies
    - Downsized Miniature Swine: A New Spin on the Oldest Model
    Interview: Selecting Miniature Swine Models for Your Toxicology Study​​​​​​
     

    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.


      

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