Flexibility by Design GMP Manufacturing

FASTEST TURNAROUND

MAXIMUM FLEXIBILITY

QUALITY ASSURANCE

From transition to scale-up, demands can change. Product enhancements, optimizations, or updated FDA regulations can push new manufacturing boundaries. Increased adoption drives scale-up while unexpected competitive intensity warrants caution. Teknova gives you the operational flexibility to meet manufacturing challenges without the expense drag of capital equipment, facilities, or dedicated labor.

With over 75,000 sq/ft of facilities and reconfigurable manufacturing space, Teknova has excellent capabilities to address your cGMP needs. Our operational capabilities and technologies include:

• Class 5 Clean Rooms
• Bioprocess Reactors
• Vessels
• Single-use Biopharma Tanks
• Large-Scale Powder V-Mixers
• 4°C Cold Room Manufacturing
• PLC Controlled Automation
• Gravimetric Analysis
• 18 Mega-Ohm, ASTM Type 1 Water, WFI & HPLC w/ continuous monitoring
• Manufacturing scales from µLs to 2000 Liters

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 alternate providers.
• Warehousing- keep your onsite inventory space low by using ours.
• Shipment- with locations near the SF Bay Area and Boston, you get easy access to priority shipping services.

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:

• Bioprocess Bags 5L-200L & Custom
• Heat-Sealable Pouches
• Bottles & Carboys
• Microvials
• Plates
• Custom Ports & Hosing
• State-of-the art automated filling stations
• Incorporating collaborative robotic bottle sorting, cap torquing verification, and vision system labeling verification.

An array of instruments and expertise is at your fingertips, ready to be deployed for your products.

• LCMS/HPLC/GC
• Atomic Absorption
• Spectrophotometry
• FTIR
• Titration
• Density
• Conductivity/Osmolality
• Solubility
• qPCR Testing for DNA
• Mycoplasma
• RNase/DNase/Protease
• Endotoxin
• Bacterial/Fungal Screen
• Bioburden
• Amino Acids
• Viral Screening
• Stability Testing
• Shelf Life/Accelerated
• USP 71 Sterility

Teknova builds quality into every product, regardless of batch size. With over 24 years in the industry supporting pharmaceutical and biotech organizations, you get the benefits of our experience.

• ISO 13485: 2016
• FDA Registered
• FDA 21 CFR part 820
• Integrated eQMS
• SCADA Integration on Key Operations
• Thermal Tracking & History

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

• 24/7 Monitoring & Video Tracking
• Triple-Redundant Backups
• SCADA Integration with Alerts
• Cloud Vaults
• Controlled Access

Can my team audit the Teknova process?
We welcome onsite audits of Teknova. 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 calling 855-242-0011. 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 straight-forward. 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.

With over 23 years of experience in manufacturing for the Pharmaceutical and Biotech community, you get expertise built into every product. We meet your quality standards while getting you to market fast.

cGMP Documentation

ISO 13485:2016 Certified

FDA 21 CFR Part 820

FDA Registered