Meet Our Partners
About BioAgilytix

Meet Our Partners

Working Together to Achieve More for Our Customers and Their Patients

BioAgilytix maintains relationships with leading bioanalytical organizations in the industry in order to build partnerships that will help us to deliver more complete services to our clients.

For bioanalytical CROs, it is of critical importance to build an internal team capable of meeting pharmaceutical and biotech customers’ drug development goals. However, at BioAgilytix we also believe it is equally critical to build strategic partnerships with organizations that can bring additional expertise, solutions, and services to supplement our own, making them more comprehensive and valuable to our customers.

As such, we work scientist-to-scientist with partner organizations and our clients to better enable bioanalytical innovation in the pharmaceutical and biotech industries.

Learn more about our current partnerships below.

Tell Us About Your Project

What are your specific assay needs? Let’s schedule a conversation to review your questions and requirements with one of our scientists.

Specializing in Life-Changing Therapies for Complex and Critically Ill Patient Populations

Clinical Trial and Consulting Services (CTI) is a global CRO delivering a complete spectrum of clinical trial and consulting services throughout the lifecycle of development, from concept to commercialization. CTI’s focused therapeutic approach provides pharmaceutical, biotechnology, and medical device firms with clinical and disease area expertise in rare diseases, regenerative medicine/gene therapy, immunology, transplantation, nephrology, hematology/oncology, neurology, infectious diseases, hepatology, cardiopulmonary, and pediatric populations.

Through this synergistic joint partnership, BioAgilytix is now CTI’s preferred partner for bioanalysis work for all pipeline programs, regardless of stage. Both companies will, when appropriate, cross refer business that could be done more efficiently by the partner.

CTI Can Provide BioAgilytix with

  • Biorepository: Global long term storage options for specimens
  • Global Kitting
  • Global Safety Testing Capabilities
  • Statistical Analysis Services
  • Clinical Trial Planning and Design
BioAgilytix Can Provide CTI with

  • Assay Development/Validation
  • Molecular Testing
  • Cellular Testing
  • Immunoassay Expertise
  • Scientific Office Support
  • Expansive/Comprehensive Lab Capabilities and Test Menu
  • Diagnostic Support
  • Immunogenicity
  • PK
  • Biomarkers
  • Neutralizing Antibody Assays
  • Potency Assays

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CTI is a full-service global CRO supporting:

Regulatory Development & Strategy
  • Clinical Trial Planning & Design
  • Protocol & Briefing Documents
  • Medical Writing, Publishing & Submissions
  • Global Regulatory Submissions
  • eCTD Publications
  • Clinical Study Reports
  • Regulatory Strategy
  • Drug Modeling & Consulting
  • Clinical Services
  • Biometrics
  • Clinical Monitoring
  • Clinical Project Management
  • Clinical Systems
  • Feasibility
  • Medical Monitoring
  • Quality Assurance
  • Safety & Pharmacovigilance
  • Regulatory Affairs Study Start-Up
  • Training & Development
  • Clinical Research Center
  • Phase I-IV
  • 30-bed inpatient unit
  • Wide variety of therapeutic areas including FIH, SAD/MAD, and PK/PD
  • Dedicated sleep unit with overnight monitoring
  • > 1000 studies completed
  • Vaccine and pandemic study experience
  • On-site clinical laboratory
  • On-site clinical pharmacy providing sterile & non-sterile compounding services
  • Laboratory Services
  • Safety testing
  • Protocol specific testing including:
  • Novel assay development
  • RUO assay validation
  • FDA/EMA compliant bio-analytical services for PK/PD analysis
  • Sample collection and kit building
  • Biorepository sample storage
  • Real World Evidence and Late Phase Research
  • Strategic Consulting
  • Evidence Generation
  • HTA Reporting & Negotiation
  • Literature Reviews
  • Delivering End-to-End Cell-Based Assay Development Services

    ATCC is the leading provider of biological materials supporting the scientific community with products, and services. With a history of innovation spanning over 90 years, ATCC offers the world’s largest and most diverse collection of human and animal cell lines, microorganisms, biological products and standards.

    ATCC and BioAgilytix’s joint partnership brings together the complementary expertise and resources sponsors need to access, develop, characterize, and store cell lines, and to develop, validate, and perform the robust cell-based assays in which they will be used.

    What ATCC Offers

    • Custom primary cell derivation
    • Custom cell immortalization solutions
    • Custom cell banking/cell line manufacturing
    • Cell authentication solutions
    • Storage and Global Distribution
    What BioAgilytix Offers

    • Customized support for cell-based assays including: pre-screening/discovery, NAb, GMP potency assays, and vaccines
    • Diverse bioanalytical platforms and cell-based assay method expertise
    • Global support for projects of any capacity

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    ATCC has the knowledge, experience and meticulous methodologies to support custom biological needs:

    Custom Primary Cell Derivation

    ATCC produces custom primary cells allowing the capability to study tissue–specific characteristics on a cellular level in vitro and to develop more biologically relevant models.

    Custom Cell Immortalization Solutions

    ATCC’s custom immortalization services provide stable genotypes of diverse cell types and tissue sources that have an extended lifespan and typically are similar to the primary parent cells.

    Custom Cell Banking/Cell Line Manufacturing

    ATCC offers expert capabilities for the preparation and characterization of master and working cell banks, either from ATCC cell lines or your proprietary cell lines.

    Cell Authentication Solutions

    ATCC is the leader in delivering standardized methods for cell line authentication used to test for contamination and identity, with numerous tests that can be ordered separately or as quality control testing with the production of cell banks.

    Storage

    ATCC has the expertise and locations to store and distribute biological materials worldwide, and offers extensive support to customers needing Master Cell Banks (MCB) and Working Cell Banks (WCB) produced, stored, and distributed to global locations. ATCC’s new specially designed biorepository allows for the large capacity storage of cell lines, and the organization also offers enhanced features for cGMPcompliant storage needs.

    Global Distribution

    ATCC packs and ships biological material to over 150 countries each year and is expert in moving biomaterials efficiently and safely from their facility directly to customers and distributors.

    Speak to a Scientist