Flexibility by Design GMP Manufacturing

FASTEST TURNAROUND

Formulations in 1–3 weeks, not months
Dedicated project managers

MAXIMUM FLEXIBILITY

Pre-qualified reagents
Proprietary, reconfigurable manufacturing facilities

QUALITY ASSURANCE

ISO 13485:2016 certified processes
US FDA registered

Experience to Help Your Projects Move Efficiently

Reagents and products made using current Good Manufacturing Practice (cGMP) guidelines are critical for creating safe, effective therapeutic and diagnostic products that consistently meet quality standards. The entire process, including strong quality management systems, record keeping, facilities, raw materials (sourcing and quality), and quality controls, can seem daunting, but you can benefit from more than two decades of experience supporting pharmaceutical and biotech organizations.

During scale-up and transitions to GMP, requirements can change. Product enhancements, optimizations, or updated FDA regulations can push new manufacturing boundaries. But you can rely on us to provide critical reagents for bioprocessing, bioproduction, vaccine production, and molecular diagnostics. We offer operational flexibility to meet manufacturing challenges without the expense drag of capital equipment, facilities, or dedicated labor.

Custom GMP Products for Your Application

Product offerings include custom formulation, formats, or volumes of culture media and supplements, viral and protein purification buffers, as well as molecular biology reagents for the life sciences and healthcare communities. We also offer inventoried and custom products and services for research of and controls for infectious diseases, including COVID-19.

If you are in the early phase of product development or already have a need for GMP manufacturing, contact us. Information about planning a transition to GMP is also available.

If you are in research, visit our page about custom RUO products.

With over ~137,000 ft2 of facilities and reconfigurable manufacturing space in Hollister, CA, and Mansfield, MA, we can address your cGMP needs. Our operational capabilities and technologies include:

  • ISO 7 (Grade C/D) clean rooms
  • ISO 5 (Grade A) manufacturing areas for aseptic processing
  • Bioprocess reactors (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
  • Manufacturing facilities designed for RUO and GMP operations
  • Separate manufacturing facilities designed for formulations containing antibiotics
  • State-of-the-art, end-to-end automation with robots, cap-torque verification, vision systems (for defects), product tracking, and segregation and packaging
  • Cold (2–8°C) and ambient storage capabilities, monitored 24/7
  • Pasteurization and steam-sterilization (autoclave) capabilities
  • Large-scale powder V-mixer
  • Single-use biopharmaceutical tanks

Extend your operational flexibility with Teknova cGMP services. We can work both upstream and downstream from the filling floor to help you address:

  • Supply chain management—we interface with your vendors or help you find lower-cost providers
  • Warehousing—keep your onsite inventory space low by using ours
  • Shipment—get easy access to priority shipping services from our locations near the San Francisco Bay Area and Boston

Getting your product into the correct format has never been easier. If you have seen it, we have probably filled it. Choose from a wide selection including:

  • Single-use, sterile, bioprocess bags (5–200 L & custom)
  • Heat-sealable pouches
  • Microvials
  • Standard and custom carboys, bottles, plates, and tubes

For more information about containers for liquids and powders, see our media packing options.

An array of instruments and expertise is at your fingertips, ready to be deployed for your products. We perform standard cGMP QC testing and will work with you to customize testing for your needs. In addition, 18 MΩ, ASTM Type 1 water, USP Water for Injection (WFI) is used for all formulations, and we continuously monitor water quality throughout our manufacturing processes.

    • LCMS/HPLC/GC
    • Elemental analysis via atomic absorption spectrophotometry
    • UV-Vis spectrophotometry
    • FTIR
    • Gravimetric analysis
    • Titration
    • Density
    • Osmolality
    • Conductivity
    • pH
    • PCR/qPCR
    • RNase/DNase testing
    • Protease testing
    • Endotoxin testing
    • Bacterial/fungal screening
    • Bioburden
    • USP sterility
    • Bacteriophage screening
    • Stability testing
    • Shelf-life/accelerated studies

Teknova builds quality into every product, regardless of batch size. With 25 years in the industry supporting pharmaceutical and biotech organizations, you get the benefits of our experience.

  • ISO 13485:2016
  • US FDA Registered (Registration # 3012652927)
  • FDA 21 CFR part 820
  • Integrated eQMS
  • Supervisory control and data acquisition (SCADA) integration on key operations
  • Thermal tracking & history
Teknova processes are ISO13485:2016 certified

Your product is our highest concern. We use strict internal document control practices to ensure your intellectual property is safe. Additional safeguards include:

  • 24/7 monitoring & video tracking
  • Triple-redundant backups
  • Supervisory control and data acquisition (SCADA) integration with alerts
  • Cloud vaults
  • Controlled access

Can my team audit the Teknova process? We welcome onsite audits of Teknova. Virtual audits are also available, especially during the COVID-19 pandemic. All manufacturing documents are sent to you for review and approval prior to production.

How do I get started with Teknova? Contact Teknova via email quotes@teknova.com or phone 1-866-787-5563. Let’s get started on your specific needs and timelines.

How long does it take? We work with you to gather the information needed to quote the item. Depending on the responsiveness, it can take 1–3 days for the quote.

How do I know my IP will be protected? We start with a non-disclosure agreement. All data is stored on a separate high security server.

What if I already have an RUO product with Teknova. How do I get this transitioned to GMP? Transitioning from RUO to cGMP is straightforward. We will need to know of any changes you would like to the product, such as grades of raw materials, containers, etc. With the changes listed, we work up a new quote for the cGMP item.

Can Teknova ship my product to multiple locations or end-users? Yes, we are able to ship to multiple locations. Location and amounts need to be stated at order submission.