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GMP Manufacturing

This is where GMP solutions start

Whether you are already in commercial production or want to set yourself up to seamlessly scale from research to GMP-grade reagents, with our innovative modular ISO 13485:2016 certified facilities, we can get you high-quality custom reagents in weeks, not months. 

 

 

 

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 13485:2016 certified since 2007, 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. 

 

MODULAR MANUFACTURING

Consistent. Flexible. Fast.

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.

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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MODULAR MANUFACTURING

 

 

Where science and

engineering meet

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 lab, and with your systems. We can accommodate your proprietary containers and are developing filling systems that can adjust to your changing needs.

Additional Information

We are expanding our facilities to better serve our customers by providing the scale needed for GMP manufacturing. Over the past two years, we have increased our footprint from 150,000 to over 400,000 square feet, adding manufacturing space, cleanrooms, and state-of-the-art equipment, including end-to-end automation with robots, cap-torque verification, vision systems (for defects), product tracking, and segregation and packaging capabilities.

  • ISO 7 (Grade C/D) cleanrooms 
  • ISO 5 (Grade A) manufacturing areas for aseptic processing
  • Over 30,000 square feet of animal-origin-free production
  • Bioprocess reactors (10 L to 750 L)
  • Tank sizes up to 1,200 L
  • Manual, semiautomated, and fully automated, flexible filling capabilities (microliters to thousands of liters) suitable for small, medium, and large-volume orders
  • Separate manufacturing facilities designed for formulations containing antibiotics
  • Pasteurization and steam-sterilization (autoclave) capabilities
  • Single-use biopharmaceutical tanks

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, California, 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.

 

  • 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.  

 

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

Set yourself up to scale

 

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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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.