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.
CTI
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.
HOW WE WORK TOGETHER
Specializing in life-changing therapies for complex and critically ill patient populations
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
CTI is a full-service global CRO supporting:
- Clinical trial planning & design
- Protocol & briefing documents
- Medical writing, publishing & submissions
- Global regulatory submissions
- eCTD Publications
- Clinical study reports
- Regulatory strategy
- Drug modeling & consulting
- Biometrics
- Clinical monitoring
- Clinical project management
- Clinical systems
- Feasibility
- Medical monitoring
- Quality assurance
- Safety & pharmacovigilance
- Regulatory affairs study start-up
- Training & development
- 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
- 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
- Strategic consulting
- Evidence generation
- HTA reporting & negotiation
- Literature reviews
ImmunoProfile
ImmunoProfile® has built a first-ever serology test panel to simultaneously measure IgG antibody levels across multiple vaccine-preventable infectious diseases. This panel test meets WHO (World Health Organization) standards for all diseases for which standards have been established to determine protection levels. Only a finger-prick blood sample is required, which is collected either at-home or from any convenient location. The private electronic test results provide a qualitative result with a numerical output for each of these eleven (11) listed infectious diseases allowing individuals to know their antibody protection level for these diseases.
HOW WE WORK TOGETHER
Offering IgG antibody testing for multiple vaccine preventable diseases
ImmunoProfile offers
- Proprietary assay
- End to end proprietary workflow
- Physician prescription
- Customer results reported
- Online website
- Logistical controls
BioAgilytix offers
- Assay validation and regulatory compliance
- Assay inventory and logistical services
- Diagnostic testing services
- Generate data for the results report
- Specimen receipt, control, and destruction procedures
ImmunoProfile® offers a first-ever serology test panel to simultaneously measure IgG antibody levels across multiple vaccine-preventable infectious diseases.
- Diphtheria
- Hepatitis A
- Hepatitis B
- H. Influenzae B
- Measles
- Mumps
- Pertussis (Whooping Cough)
- Polio
- Rubella (German Measles)
- Tetanus (Lockjaw)
- Varicella
- Availability: Consumer online or B2B partnering
- Prescription: Provided online or through B2B partner
- Easy: Finger prick specimen collection
- Reliable: Run at BioAgilytix on Luminex Platform
- Standardized: Results match WHO standards
- Secure: Results available through secure online private portal
- Accessible: View and share results as desired
- Accurate: Equivalent to central lab results
- ImmunoProfile® can customize its proprietary assay for Research
- Applications, CRO Trials, B2B Partner testing requirements, or other specific applications.
- In addition to the tests offered commercially the assay is capable of running results for both the Spike RBD and Nucleocapsid antibody test for COVID-19 on a Research Use Only basis.
- For inquires please contact: wshea@immunoprofile.com
Microba
Microba Life Sciences is a precision microbiome company delivering flexible end-to-end support for clinical trial applications. The microbiome is now a common clinical endpoint for trials across a broad range of health indications. Together with BioAgilytix, Microba can enable clients to confidently include microbiome endpoints in their trials to test the direct and indirect impacts of this important physiological system.
Microba’s precision microbiome science ensures clients get the most impact from their trials. Services include consultation for trial design, sample collection, trusted sample processing with high resolution shotgun metagenomic sequencing, and industry-leading analytics. Microba can also support the application of microbiome data for complex analytics, such as determining responder profiles and identifying biomarkers of response.
HOW WE WORK TOGETHER
Applying precision microbiome analysis to measure and understand the impact of interventional therapies
What Microba offers
- Specialist microbiome lab
- End to end trial services
- Expert consultation and advice
- Global wet and dry lab services
- Industry-leading bioinformatic solutions for reliable results generation and analysis
What BioAgilytix offers
- Advanced bioanalytical solutions to support all phases of drug development across disease states and industries
- Assay development, validation, and sample analysis under non-GLP, GLP, and GMP quality control testing
- Cell & Gene Therapy solutions
- Human biomarker bioanalytics services
- Immunogenicity
- Cell-based assay services
- PK
- Diagnostic testing services
Microba is a specialist microbiome services provider with end-to-end solutions including:
- Microbiome experts with clinical trial experience
- Clinical trial design for microbiome endpoints
- Trial planning for analysis success
- Leveraging the microbiome as a primary or secondary endpoint
- Sample collection kits
- DNA extraction
- Library preparation
- Shotgun metagenomic sequencing
- Targeted bacterial PCR
- Human and animal applications
- Accredited: GLP/GCP; ISO 15189; CLIA/CAP
- Industry-leading bioinformatics for accurate community profiling
- Species and functional profiling
- Strain tracking
- AMR, CAZyme, pathogen detection
- Exploratory biostatistics
- Data analytics for dossier submission
- Biomarker identification
- Drug responder profiles
- Interpretation of microbiome signals and biomarkers
- Literature reviews
Sekisui Medical
Sekisui Medical conducts various preclinical pharmacokinetic studies including those using
radio-labeled compounds. The organization started operating its laboratory in Japan in May 1965 and has dedicated itself to drug development research for nearly 60 years since. Sekisui continues to expand its analytical capabilities with its own proprietary technology which reaches for higher
sensitivity and selectivity to accommodate the analysis of diverse drug modalities and biomarkers.
The Sekisui Medical Laboratory is a fully accredited institution of the Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC).
HOW WE WORK TOGETHER
Bioagilytix customers requiring either a Japanese-based laboratory for support or the unique skills
and capabilities of the Sekisui team that can not be provided by Bioagilytix will be referred to the
Sekisui team. In particular, Sekisui’s extensive experience with radiolabeled compounds and the
associated in vivo studies using those radiolabeled compounds will benefit Bioagilytix customers.
Sekisui customers requiring either a North American or European laboratory for support or the
diverse capabilities of Bioagilytix will be referred to one of the 6 different Bioagilytix locations
globally for support. The primary focus of Bioagilytix support for Sekisui clients will be biomarker
testing, but may expand based on individual need.
What Sekisui offers
- In Vivo and In Vitro Pharmacokinetic Studies
- Synthesis of radio-labeled compounds
- High Sensitivity/Selectivity Analytical Services
What BioAgilytix offers
- Biomarker analysis including primary and secondary endpoints along with exploratory biomarkers.
- Pharmacokinetics and immunogenicity assessments, and CMC bioanalytical testing services.
- Advanced bioanalytical solutions to support all phases of drug development across disease states and industries.
- Assay development, validation, and sample analysis under non-GLP, GLP, and GMP quality control testing.
Sekisui Medical offers preclinical pharmacokinetic studies and high sensitivity/selectivity analytical services.
With their fully AAALAC accredited facilities, Sekisui offer in vivo absorption, distribution, metabolism, and excretion studies with various radionuclides, animal species, and administration routes, together with in vitro studies.
- Quantitative whole-body autoradiography (QWBA)
- Metabolite analysis and structural elucidation
- Feto-placental transfer and lacteal secretion/excretion study
- Pharmacokinetic study using chimeric mice with humanized liver
- Patient-derived xenografts (PDX)
- Protein binding / red blood cell partitioning (in vitro)
Based on the in-depth knowledge acquired through years of experience, Sekisui offers labeling compounds with radioisotope or stable isotope (SI), as well as manufacturing of active pharmaceutical ingredients (API) for clinical trials under GMP.
- Synthesis of labeled compounds (14C, 3H, 35S, 51Cr, 90Y, 111In, 125I, and more)
- Site-selective radiolabeling of nucleic acids
- Stable isotope labeling (13C, 2H, and more)
- Production of 14C labeled API under GMP
Sekisui offers sample analysis for pharmacokinetic and toxicokinetic studies, and measures biomarkers and antibodies via various immunoassays.
- Bioanalysis by LC-MS/MS, RIA, ELISA (SIMOA), EIA, rt-PCR, etc.
- Highly sensitive bioanalysis of oligonucleotides
- Measurement of Anti-Drug Antibody (ADA) concentration / evaluation of neutralizing activity
- Measurement of biomarkers (endogenous compounds and genes)
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