INVESTING IN YOUR SUCCESS
Discover our
state-of-the-art facility
Two years in the making, our new ISO 13485:2016 certified facility
features a modular platform with the flexibility to manufacture
fully customized reagents.
Every detail was considered for production quality, efficiency, accuracy,
and throughput. With cutting-edge automation, continuous production,
and lot sizes up to 750 L, we can quickly turn around high-quality
reagents for every step of your workflow.
Our flexible services can help expand your operational capacity.
Supply chain management. We can help source and manage third-party suppliers.
Warehousing. Talk to our team about our storage solutions. Our facilities in Hollister, CA, include cold (2°C–8°C) and ambient storage capabilities and are monitored 24/7.
Temperature-controlled shipping. We offer seamless delivery with a wide range of options that protect the integrity of your product, including a monitored temperature-controlled service. Our packaging is designed for easy delivery into your facilities, and we can perform shipping validation studies as needed for specific products.
Integrated eQMS. Our Electronic Quality Management System (eQMS) offers seamless integration, giving you transparency into how we manage and document product development, quality, and compliance across our organization.
Contract manufacturing. We can help you get your product to market faster with confidence, with support ranging from AAV production and analytics to OEM kitting and custom labeling.
Stability studies. We can develop and execute a testing program to assign an accurate shelf life to your custom product. Learn more.
Bridging studies. To help you quickly and seamlessly transition your RUO product to GMP, we can perform any required qualification and validation work through our established workflows.
Our facilities and Quality Management System (QMS) are ISO 13485:2016 certified by Intertek, an MDSAP recognized Auditing Organization.
We are committed to protecting your products and your intellectual property. We use strict internal document-control practices and additional safeguards, including:
- 24/7 monitoring and video tracking
- Triple-redundant backups
- Supervisory control and data acquisition (SCADA) integration with alerts
- Cloud vaults
- Controlled access
- Acids and Bases
- Additives
- Alcohols
- Culture Media
- Buffers
- Detergents and Surfactants
- Salts
- Sugars
DISCOVER THE MODULAR MANUFACTURING DIFFERENCE
Where science and
engineering meet
Our unique modular manufacturing platform can be easily configured to make your custom GMP products on demand, allowing us to support emerging therapeutic modalities, like cell and gene therapy.
By combining the precision and flexibility of our platform with our rigorous quality management system, we can manufacture custom products quickly without compromising quality. Whether you are looking for standard solutions or complex formulations and formats, we make custom products at the scale you need when you need them.
OUR EXPERTISE
Add our expertise to
your team
With over 25 years of experience manufacturing critical reagents for bioprocessing,
bioproduction, vaccine production, and diagnostics, you can rely on
getting consistent formulations in the quantities you need.