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GMP Manufacturing

Introducing our new GMP facility

Our newly certified ISO 13485:2016 facility is purpose-built to support your manufacturing needs, whether you are already in commercial production or want to set yourself up to seamlessly scale from research to GMP-grade reagents.

TOUR OUR NEW FACILITY THE MODULAR MANUFACTURING DIFFERENCE TRANSITIONING FROM RUO TO GMP

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.

Purpose-built for seamless scale-up

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

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, from small-scale 10 L batches to 750 L process trains that we can CIP/SIP for your product.

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.

 

  • Increased sterility with unidirectional flow of materials and technicians.
  • Rigorous sanitization program and continuous monitoring of cleanroom conditions.

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, 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.

 

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

Transitioning from 

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.

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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.

Designed for discovery

Our research and development and scientific support teams are here to help, offering their unique expertise in everything from optimizing reagent formulations to gene therapy bioprocessing scale-up.

Engineered for your success

Our on-site engineers continuously work to design formats that function seamlessly in your hands, in your facility, and with your systems. We can accommodate your proprietary containers and are developing filling systems that can adjust to your changing needs.

Let us be your media kitchen

Let us make your custom, high-end media. We have the flexibility and scale to meet your GMP manufacturing needs, saving you the expense of equipment and facilities and helping you get more value out of your team’s time and skills.

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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.

Consistent quality

 

Our Quality Management System is designed to ensure you get the quality reagents you need to create safe, effective diagnostic and therapeutic products. From raw material testing and process controls to finished goods testing and product release, we deliver end-to-end quality for all standard and custom products. 

GMP compliant


We have been ISO 13485 certified since 2016, serving large and small customers across the life science industry. From standard culture media, reagents, and water to proprietary formulations, we manufacture all our GMP products using stringent quality controls.

 

 

Fast turnaround

 

Getting the critical reagents you need should never hold up your development or production. Whether you want 2 L or 2,000 L, we can manufacture your custom GMP products in weeks, not months. 

 

 

 

we're custom by default

Don’t see what you’re looking for?

 

Talk to our team about our custom solutions. We can partner with you so you can count on one trusted supplier from RUO to GMP.  

LET'S FIND YOUR SOLUTION