INVESTING IN YOUR SUCCESS
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 new manufacturing facility integrates with our current production facilities in Hollister, CA, to augment capacity and modernize capabilities. With the opening of our newest, state-of-the-art facility, we have increased our footprint to over 200,000 square feet, enabling us to better serve our customers by providing the scale and flexibility needed for GMP manufacturing.
- Over 10,000 square feet of ISO 7 and 8 cleanrooms
- ISO 5 (Grade A) semi-automatic bottle fillers
- Over 30,000 square feet of animal-origin-free areas
- Flexible lot sizes to meet your needs, from small-scale 10 L batches to 750 L process trains that we can CIP/SIP for your product
- Vessel sizes ranging from 10 L to 750 L
- Manual, semi-automated, and fully-automated, flexible filling capabilities (microliters to thousands of liters) suitable for small, medium, and large-volume orders
- Pasteurization and steam sterilization (autoclave) capabilities
- Single-use vessels and equipment
- End-to-end automation with robots, cap-torque verification, and vision systems (for defects)
- Product tracking, segregation and packaging capabilities
- Closed-system bag filling using aseptic series locks to minimize product contamination risks
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.
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.
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
RUO to GMP
Are you currently using research-grade products that you may need to transition to GMP in the future? We can help you plan your transition by ensuring you are starting with the right raw materials and processes to scale seamlessly.
We understand the different challenges our customers face as they progress from discovery to commercialization. Our manufacturing, technical, and quality capabilities ensure that journey is seamless. Whether you need 1 L of a standard research grade product in a bottle or 500 L of proprietary formulation in single-use bags, we’ve designed our systems and processes to seamlessly scale with your workflow.
We can supply GMP products to support each of these different workflows. We will work with you to understand your goals so we can adapt to your processes, from early research to product development and commercialization.
DISCOVER THE MODULAR MANUFACTURING DIFFERENCE
Where science and
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.
Add our expertise to
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.