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ISO Certified Facilities

Discover our state-of-the-art facilities

Purpose-built to support you from early-stage research through commercialization, our new ISO 13485:2016 certified facility features a modular platform with the flexibility to quickly manufacture both small and large volumes of custom reagents with impeccable consistency and quality.

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INVESTING IN YOUR SUCCESS

 

Purpose-built by

industry experts

Every detail was considered for production quality, efficiency, accuracy,

and throughput. With cutting-edge automation, continuous production,

and burst capacity for lots of up to 2000 L, we can quickly turn around

high-quality reagents for every step of your workflow.

Designed for seamless scale-up

Transition from RUO to GMP with the support of our custom-designed facility that can easily adapt to produce tailored formulations and formats.

We offer flexible RUO, RUO+, and GMP manufacturing grades that are designed to help you work efficiently and contain costs as you move from research through to clinical production.

See our GMP capabilities

Over 10,000 square feet of ISO 7 and 8 cleanrooms

We have increased flexibility and reliability with two mirror-image ISO 7 production facilities, each with dedicated air handling units, ISO 8 formulation rooms, and a variety of manufacturing options to meet your custom needs.

 

  • Automated and manual dispensing options across multiple trains, supporting a large variety of batch sizes and formats.
  • Flexible lot sizes to meet your needs, with burst capacity for lot sizes up to 2,000 L, and the ability to CIP/SIP for your product.
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Animal-free and endotoxin-controlled

Automated systems connect formulation and dispensing tanks to support end-to-end, aseptic manufacturing, with additional mobile vessels that use single-use equipment to ensure there's no product cross-contamination.

 

  • Improved contamination control with unidirectional flow of materials and technicians.
  • Rigorous sanitization program and routine monitoring of cleanroom conditions.
Learn about our QMS

Additional Information

Learn more about how the capabilities and services we offer can support you from discovery through commercialization.

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, with build sizes up to 2,000 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
  • Integrated eQMS

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.

 

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

WE GO BEYOND INDUSTRY STANDARDS

 

Quality you

can count on

Our Quality Management System is designed by pharmaceutically-trained experts to enable us to manufacture custom

reagents quickly without compromising quality. We have validated our equipment and manufacturing processes, and follow 

rigorous testing and documentation procedures that go beyond industry standards to ensure you get reproducible results.

Rigorous QC testing

 

 

Get results you can trust with our suite of 20 quality control assays that ensure the performance of our raw materials and finished goods. Custom testing options are available to meet your specific requirements.

See our tests

ISO 13485 certified

 

 

Our state-of-the-art facilities are built to meet the needs of customers across the life science industry. From culture media, reagents, and water to proprietary formulations, we manufacture consistent products you can count on.

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Industry expertise

 

 

Our manufacturing process was designed by a team of industry-trained experts with an intimate understanding of your workflow and requirements. They are here to help you find your ideal solution, every step of the way.

Meet the team

Find out what’s possible

 

Talk to our consultants today to discover custom solutions that can help you achieve your goals.

 

Get in touch:

1.800.209.4488

Monday to Friday

8:00AM–5:00PM PT

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