Trusted CRO for Innovative Drug Development
Discovery, Innovation, Service, and Robust Science are at the heart of what we do.
Our Services
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Pharmacokinetics and Pharmacodynamics
BioTherapeutic Analysis
Dose-Concentration Testing
Biodistribution
Tissue and Biopsy Assays
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Immunogenicity testing
Anti-Drug Antibodies
ELISA & ECLA
Flow Cytometry
Clinical Studies
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Biomarker Analysis
Novel Method Development
Disease State Biomarkers
Mechanism of Action Studies
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Advanced Cell Engineering
Cell Based Assays / Cell Line Development
Knock-out
Gene Edited and Reporter Lines
Primary Cell Isolation
Co-culture and growth on ECM/matrices
Characterization of primary cell activation (T cell activation, Neutrophils, Hematopoietic stem cells)
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Cell and Gene Therapy
Capsid Immunogenicity
Vector Packaging
Gene Copy Number
Sanger Sequencing
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Molecular Biology
Genomic DNA and mRNA isolation
RT-PCR Analysis
Gene Copy Analysis
Knock-out, Insertion
Over-Expression
QPCR
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Protein Characterization
Enzyme Activity
Antibody Binding
Stability
Purity
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Stability Studies
Long term storage
Accelerated stability testing
Biobanking
Cryo-storage
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Botulinum Neurotoxin
Immunogenicity Methods Validation and Development
Anti-toxin Antibody Assessment
Neurotoxin Studies
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Microbiology testing
Pathogen testing
Mycoplasma Testing
Endotoxin (LPS)
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Medical Device Testing
Bio Capability
Cell Cytotoxicity
Complement activation
Leachables and Extractables evaluation and consultation
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Consultations
Comprehensive consultation services
Research and development supportConsultation for startups and established companies
Strategic advice
Laboratory
Modern Laboratory with BioAnalytical Chemistry, Molecular Biology and Cell Culture Infrastructure
At BioTether Sciences, our state-of-the-art laboratory is designed to support advanced research in bioanalytical chemistry and cell culture. Equipped with modern facilities, our laboratory features wet chemistry benches, plate readers, and essential tools like PCR (Polymerase Chain Reaction) and Western Blot (WB) technologies. We maintain BSL2 cell culture rooms, providing a controlled environment for sensitive experiments. Our infrastructure includes specialized equipment such as a Nucleofector for transfection, Magnetic-Activated Cell Sorting (MACS), Flow Cytometry, advanced microscopy techniques, and various detection methods, including fluorescence, luminescence, and colorimetric assays.
BSL2 cell culture room
Nucleofector, MACS, Flow Cytometry, Microscopy
QPCR, Sanger Sequencer, Gel Electrophoresis,
Fluorescence, Luminescence and Colorimetric detectors
GMP and GLP compliant laboratory with SOP driven quality systems
Quality Systems
Our quality systems are designed to ensure the highest standards in scientific research. We maintain GMP and GLP compliance through rigorous, SOP-driven processes supported by a comprehensive Quality Manual and SOP Index. Our instruments undergo regular qualification and calibration, while our robust training program ensures team expertise and strict adherence to compliance protocols.
Key Features of Our Quality Systems:
Our operations are guided by a robust framework of Standard Operating Procedures (SOPs) detailed in our comprehensive Quality Manual and SOP Index. This ensures consistency and reliability in every aspect of our research.
SOP-Driven Processes
We understand the importance of precise measurements in scientific research. Therefore, all our instruments undergo regular qualification and calibration to guarantee their performance and accuracy.
Instrument Qualification and Calibration
Our dedicated training program equips our team with the expertise needed to uphold strict compliance protocols. We invest in continuous education and skill development to ensure that our staff is knowledgeable and proficient in the latest quality standards and practices.
Comprehensive Training Program
Quality is at the core of everything we do. Our commitment to excellence drives us to constantly evaluate and improve our quality systems, ensuring that we deliver the best possible outcomes for our clients.
Commitment to Excellence
Through these rigorous quality systems, BioTether Sciences not only meets regulatory requirements but also sets a standard of excellence in the biotechnology sector. Partner with us for your research needs and experience the assurance of quality at every step.
Our Customers
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Early-Stage Startups
We cater to emerging companies that are in the ideation or pre-startup phases. These innovators are often working on groundbreaking ideas in areas such as biotechnology, ag-tech, and medical devices. For example, a biotech startup developing a novel therapeutic approach to combat cancer may seek our advanced cell engineering and biomarker analysis services to validate their concepts and accelerate their research.
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Growing Biotech Firms
As startups mature into full-fledged biotech firms, they require more sophisticated services to support their research and development. Many companies have ambitious non-clinical and clinical plans that require robust, on-demand, bioanalytical support to propel their innovations to market.
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Academic Institutions
We also serve universities and research institutions that are conducting innovative research in molecular biology and bioanalysis. These entities often rely on our expertise for their studies, whether it’s for CRISPR line generation or protein characterization.
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Pharmaceutical Companies
The established biopharma companies require comprehensive research and development services to refine their products. Firms developing cutting-edge cell and gene therapies, for example, rely on our expertise in CRISPR/Cas9 line generation, metabolic biomarkers, and activity assays to ensure their therapies are safe and effective. These organizations benefit from our GLP and GMP compliant laboratories to ensure the highest quality in their research efforts, whether they’re developing new therapies or conducting clinical studies.
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Contract Research Organizations (CROs)
We partner with other CROs that may need specialized services that enhance their existing offerings. This collaboration helps us expand our reach and supports mutual growth in the dynamic biotech landscape.
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Medical Device Innovators
Partnering with companies developing combination medical devices that integrate biologics and engineering solutions, providing precise biomarker analysis and robust testing services to help navigate regulatory complexities and ensure product efficacy.
Drug discovery phases
BioTether Sciences provides comprehensive support throughout all phases of drug discovery, from basic research to phase 3 clinical trials.
Expertise in lead identification, optimization, and formulation development. Focus on creating effective and viable drug candidates.
Drug Discovery Services
Basic Research
Work alongside researchers to explore novel targets and mechanisms. Utilize advanced technologies and methodologies for innovative therapies.
Pre-Clinical Testing
Thorough evaluation of pharmacokinetics, pharmacodynamics, and toxicology. Provide essential data to inform the safety and efficacy of drug candidates.
Clinical Trials Support
Tailored solutions to facilitate compliance with regulatory standards. Rigorous data collection to ensure robust clinical trial results.
The Value We Bring to Our Clients
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Personalized Attention
BioTether Sciences is committed to providing personalized, hands-on service to our clients. As a boutique CRO, we take the time to understand your unique requirements, delivering tailored solutions with the attention to detail your project deserves.
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Flexibility & Agility
Flexibility is at the core of our approach. Our boutique structure allows us to quickly adjust to changing project requirements, ensuring that your goals are met with precision and agility.
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Expertise
We offer a wealth of expertise -our CRO is staffed with experts in bioanalysis, molecular biology, advanced cell engineering, protein characterization, and methods development, delivering top-tier scientific insights to drive your research forward.
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Cost
Our approach emphasizes cost-effectiveness, delivering exceptional research services while maintaining financial efficiency and value.
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Communication
BioTether Sciences values transparent and direct communication, allowing for seamless interaction with our team so you stay informed and engaged at every stage of your research.
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Quality
We deliver excellence through a focus on quality, ensuring that every phase of your project is executed with accuracy, consistency, and attention to detail.
About Us
At BioTether Sciences, we are a boutique biotechnology contract research organization (CRO) dedicated to providing innovative solutions for drug development. Founded in 2015 with a strong R&D focus on protein engineering, affinity hemofilter technology, and novel drug formulations, we expanded in 2019 to establish our CRO business group, specializing in bioanalysis, biochemistry, molecular and cell biology.
Story
Our management team comprises seasoned professionals, each bringing over 20 years of experience in the pharmaceutical, diagnostic, and medical device fields. With a background directing laboratories at BioMarin Pharmaceuticals, Pacific BioLabs, and Bay Bioanalytical Labs, our leadership possesses a unique understanding of bioanalysis's critical role in the biopharmaceutical and medical device industries. Our team members have made significant contributions to the fields of bioanalysis, immunology, cancer, and neuroscience, with numerous publications reflecting their expertise. This extensive background ensures our commitment to delivering high-quality, reliable results for our clients.Our team members have made significant contributions to the fields of bioanalysis, immunology, cancer, and neuroscience, with numerous publications reflecting their expertise. This extensive background ensures our commitment to delivering high-quality, reliable results for our clients. Our team members have made significant contributions to the fields of bioanalysis, immunology, cancer, and neuroscience, with numerous publications reflecting their expertise. This extensive background ensures our commitment to delivering high-quality, reliable results for our clients.
Experience
Our CRO is strategically located in Novato, a central hub within the vibrant North Bay Biotechnology Sector. Nestled in the beautiful Marin and Sonoma counties, our proximity to renowned biopharmaceutical companies such as BioMarin and Ultragenyx, as well as leading research institutions like The Buck Institute for Research on Aging, places us at the forefront of scientific discovery. We are less than an hour away from South San Francisco, a global biotech hub that is home to industry giants, startups, and world-class research institutions. This close proximity to South San Francisco's thriving biotech corridor allows us to maintain strong connections with key players in the sector while offering the benefits of a creative, safe, and inspirational work environment in the North Bay.
Location
BioTether Sciences™, Inc is a biotechnology company devoted to the development of solutions to unmet medical problems. We wish to improve people's lives through innovative therapeutics and medical devices. Discovery, innovation, and robust science is at the heart of what we do. We work on the most difficult, serious diseases. BioTether Sciences staff brings decades of technical experience, and a wealth of publications, grants, and patents. Dedicated to consistently provide high quality research, development and analytical services that meet customer and regulatory requirements.
Mission and Values
Testimonials
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The team went above and beyond to fit our testing into their schedule promptly. Their expertise in various testing methods was evident, and they helped us customize the perfect approach for our project. Outstanding service!
~Tim
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I’ve chosen to outsource our specialized gene and cell therapy projects to BioTether Sciences multiple times, and I couldn’t be happier with the results. The team is incredibly flexible, making communication quick and seamless. Fast, easy, and reliable.
~John
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If you haven't worked with this bioanalytical lab, you're missing out! The expert scientists bring years of insight and a fresh perspective that can elevate your projects. They're not only exceptionally knowledgeable but also a pleasure to collaborate with. Definitely request a quote—you won't be disappointed!
~Lee