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  • Trusted CRO for Innovative Drug Development

    Discovery, Innovation, Service, and Robust Science are at the heart of what we do.

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Our Services

Pharmacokinetics Testing, PK/PD

Pharmacokinetics Testing

BioTherapeutic Analysis
​Dose-Concentration Testing
​Biodistribution
​Tissue and Biopsy Assays

Immunogenicity Testing

Immunogenicity Testing

Anti-Drug Antibodies
​ELISA & ECLA
​Flow Cytometry
​Clinical Studies

Biomarker Analysis, Gene and cell therapy

Biomarker Analysis

Novel Method Development
​Disease State Biomarkers
​Mechanism of Action Studies


Advanced Cell Engineering, cell based assay, gene editing

Advanced Cell Engineering

Cell Based Assays
​Cell Line Development
​Knock-out

Gene Edited and Reporter Lines
​​Primary Cell Isolation


Cell and Gene Therapy, vector packaging

Cell and Gene Therapy

Capsid Immunogenicity
​Vector Packaging
​Gene Copy Number
​Sanger Sequencing



Molecular biology

Molecular Biology

Genomic DNA and mRNA isolation

RT-PCR Analysis
Gene Copy Analysis
Knock-out, Insertion
Over-Expression
QPCR
Protein Characterization, enzyme activity, antibody

Protein Characterization

Enzyme Activity
Antibody Binding 

Stability 

Purity

Stability Studies, cryostorage, cryopreservation

Stability Studies

Long term storage
Accelerated stability testing Biobanking 

Cryo-storage

Botulinum Neurotoxin, immunogenecity, anti-toxin antibody assessment

Botulinum Neurotoxin

Immunogenicity Methods Validation and Development

Anti-toxin Antibody Assessment
Neurotoxin Studies 

Microbiology, Pathogen, Mycoplasma, Endotoxin testing

Microbiology testing

Pathogen testing

Mycoplasma Testing

Endotoxin (LPS)


 

Medical Device testing

Medical device testing

Bio Capability
Cell Cytotoxicity

Complement activation

Leachables and Extractables evaluation and consultation

Consultation

Consultations

Comprehensive consultation services
Research and development support

Consultation for startups and established companies

      Strategic advice

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Laboratory

BioTether Sciences state-of-the-art 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



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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:

SOP-Driven Processes

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.


Instrument Qualification and Calibration 

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.


Comprehensive Training Program

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.

Commitment to Excellence

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.

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.
GMP, Good Manufacturing Practice, regulated bioanalytical testing
GLP, Good Laboratory practice, Regulated bioanalytical testing


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Our Customers

Our diverse customer base ranges from early-stage startups to established pharmaceutical giants, all united by their need for innovative biotechnology solutions.

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.

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.




Academic Institutions

We also serve universities and research institutions that are conducting cutting-edge 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.





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.

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.









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.








GET IN TOUCH WITH US

Drug discovery phases

 BioTether Sciences provides comprehensive support throughout all phases of drug discovery, from basic research to phase 3 clinical trials.

Drug Discovery

Drug Discovery Services

Expertise in lead identification, optimization, and formulation development. Focus on creating effective and viable drug candidates.


Basic Research

Basic Research

Work alongside researchers to explore novel targets and mechanisms. Utilize advanced technologies and methodologies for innovative therapies.


Drug Discovery
Pre-Clinical testing

Pre-Clinical Testing

Thorough evaluation of pharmacokinetics, pharmacodynamics, and toxicology. Provide essential data to inform the safety and efficacy of drug candidates.

Clinical Research

Clinical Trials Support

Tailored solutions to facilitate compliance with regulatory standards. Rigorous data collection to ensure robust clinical trial results.

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The Value We Bring to Our Clients


Attention to customers

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.


Flexible and agile approach to customers

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.


Expertise and Specialization

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. 
Cost effectiveness, savings

Cost

Our approach emphasizes cost-effectiveness, delivering exceptional research services while maintaining financial efficiency and value.



Transparent communication

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.


Quality, attention to details

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.


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About Us

Story

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. 

BioTether Sciences Building location Novato
BioTether Team and experience

Experience

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.

Location

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. 

Novato Hills
BioTether Team and experience

Mission and Values

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.

Testimonials

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

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


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