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.
MBS
MBS, the antibody development arm of BBI Solutions, has a 30-year history of developing custom high quality monoclonal and polyclonal antibodies for bioanalytical and diagnostic use. Each project begins with a thorough discussion of the clients’ goals and timelines leading to a customized development and antibody characterization strategy. Collaboration, communication, and quality make up the foundation for driving high success of our projects.
HOW WE WORK TOGETHER
We collaborate to provide high quality custom antibody reagents in support of timely bioanalytical assay creation and test development.
BioAgilytix can provide you with
- 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
- Consultative support through our Scientific office
- Expansive/Comprehensive lab capabilities and off-the-shelf assay menu
BioAgilytix provides customers with the following key data deliverables:
- Pharmacokinetics (PK)
- Immunogenicity
- Biomarkers
- CMC bioanalytical (potency assays)
BioAgilytix utilizes the following key assay formats:
- Immunoassays
- Cell-based assay services
- Molecular assays
- Diagnostic testing services
MBS can provide you with
- Polyclonal and Monoclonal Antibody Development
- Antibodies for Therapeutic Drug Detection (PK)
- Antibodies for Immunogenicity (ADA & Nab)
- Collaborative strategy development
- Multiple specificity and/or application goals accomplished in single project
- Application-specific antibody characterization throughout development including blocking/non-blocking ELISA, IHC, & flow cytometry (coming soon)
Maine Biotechnology Services, part of BBI Solutions, offers comprehensive custom antibody development supporting bioanalytical test development:
- Collaboratively developed strategy resulting in comprehensive project plan
- Early access to purified and biotinylated antibody via proprietary Multipure platform
- Array of antibody characterization and selection formats such as ELISA, immunohistochemistry, and immunocytochemistry
- Technical support throughout entire project with guidance at every project milestone
- Collaborative strategy and detailed project plan
- Custom antigen affinity purification with multistep polishing options
- Technical support throughout project
- ISO-13485:2016 certified
- Flexible product scales from 1mg up through multiple grams
- Serum free and Ultra-low bovine IgG serum culture
- Cell line storage service
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
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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