January 15, 2021

Navigating your Cleanroom Options As A Start-Up

Dan Dernbach
Navigating your Cleanroom Options As A Start-Up Teaser

How to decide between a CMO, rental space, or building your own compliant space.

As you start your journey in researching, developing, and piloting your product, you realize the question, “Should I rent or build a cleanroom?” is pivotal. Each start-up is different and has its own unique set of challenges and needs. Therefore, we will be covering the different options available to you and which will best fit production for your start-up.

CMOs vs. Building Your Own Facility

Contract Manufacturing Organizations (CMOs) offer manufacturing capabilities to suit different and specific industry sectors/niches. However, there are quite a few drawbacks when it comes to working with a CMO. While under contract, but not in full control of the cleanroom, you have to keep in mind scheduling times, intellectual property security, and the need for equipment and materials. All of these aspects can significantly impact your decision.

While having a facility that allows you to conduct your practices is a must, you must share your intellectual property (IP), cleanroom space, or specific activities.

The second option in contrast to CMOs is to build your own cleanroom. Of course, the obvious benefit is the ability to have full control over your entire production and not worry about IP breaches, security, or scheduling times. However, this process of building, maintaining, and qualifying your own cleanroom with cGMP standards is extremely costly and will take a significant amount of time and expertise that most start-ups may not be able to support.

 

A few things to consider when building:

  • Creating the Utility Matrix
  • Designing support systems
  • Qualification times
  • Construction and commissioning
  • Temperature and humidity control
  • Implementing air filters
  • Pressurization
  • Cleaning and environmental monitoring
 

While both of these standard cleanroom options have benefits and drawbacks, over the years Azzur Group noticed neither method allowed start-ups to focus solely on their science and protect their IP. From this, the Azzur Cleanrooms On Demand™️ (COD) hybrid model was conceptualized and brought to market.


Azzur Cleanrooms on Demand™️

Our facilities include cGMP-compliant cleanroom space, warehousing, and material management. This means you can execute activities without the need for facility ownership or reliance on CMOs.

Unlike with CMOs, renting a cleanroom with Azzur COD allows you to keep any and all intellectual property that is developed in the facility. You also have full control over your space and all activities. With the Azzur Cleanrooms on Demand™️ option, a need for a third party is completely eliminated.


Building a Cleanroom

Pros Cons
  • Full control over IP

  • Ability to make process changes

  • Built for your specific manufacturing needs

  • No scheduling issues

  • Full control over facility space and Quality Control

  • Costly

  • The need for maintenance

  • Facility must be validated by the owner

  • Length of time for construction and development


Partnering with a CMO

Pros Cons
  • The CMO provides all operators for manufacturing activities.

  • Can meet specific needs and niches

  • “Hands-off” approach

  • IP must be shared

  • Complex tech transfer plans

  • Space is reserved for a limited time for a finite set of activities.

  • Lack of flexibility to change process as needed.


Renting an Azzur Cleanroom

Pros  
  • Full control over IP, space, QC, schedule, and activities

  • Comes fully equipped

  • Security throughout the facility

  • Can meet the needs of very specific industries, customizable

  • No schedules or timeline drawbacks

  • No maintenance needed

  • Phase-Appropriate cGMP compliant

 


As listed above, with Azzur COD you are able to get all the benefits of building your own facility without the timeline setbacks, cGMP compliance technicalities, major costs, or worry of any maintenance. Additionally, since there are no manufacturing schedules and you can make as many batches as you want during your contract. This type of flexibility is crucial for early-phase development. Therefore, Azzur COD was designed specifically to keep you focused on your science, while Azzur focuses on compliance.


Cut your timeline by as much as 75% and cost by 70-80%

Overall, if you are in the early phases of research and development, then renting a cleanroom will be the best option for you to get your drug, therapy, or device to market quickly and safely. Even if you are ready to build COD can be a bridge to your own facility. Building a cleanroom is a more viable option once your production has matured. See the checklist below to better understand which may work best for you.

  • Is this the first time you have developed a product?

  • Does your budget allow for equipment and special features?

  • Is your manufacturing process locked down?

  • Do you have a GMP-compliant quality system in place?

  • Do you have trained personnel?

  • Do you have thorough knowledge of the regulations needed for your specific production?

  • Is a cleanroom an immediate need?

  • Are you familiar with the type of test you will be conducting?

  • Are only researching and developing one specific product?

If you are at the stage where you are ready to build a cleanroom, Azzur can still help provide you with resources to get you started on your next big journey!

Ready to explore COD’s cGMP-compliant cleanrooms? Take a virtual tour, and contact us to get more information!

Dan Dernbach Image
Author

Dan Dernbach

As Vice President of Operations at Azzur Cleanrooms On Demand™️, Dan Dernbach has more than 25 years of experience in life science and healthcare with comprehensive operational expertise. Azzur COD’s hybrid model includes on-demand cleanrooms and related services for materials management, asset management, and supply chain. In San Diego, the firm's second major location, Dan enjoys working with customers to progress their research and development and enable them to get their products into the hands of end-users as efficiently as possible.