In today’s challenging fundraising market, biotech companies are much more focused on conserving their cash than they were just a few years ago during the pandemic funding boom.
Yet venture capitalists still are looking for a quick return on their investments… the result is biotech companies are needing to be smarter with more limited funds while not delaying their critical milestones.
In nearly every start up or R&D programme, money must be invested before a return is expected. Just to keep the lights on and the development of a new product can take enormous sums of money.
Without new sales from a preexisting product, the funds in the startups bank can rapidly decrease. The rate at which this money decreases is called a “burn rate” and every executive has in mind.
The rate at which this money decreases is called a “burn rate”
Once the funds are depleted, they are out of runway to launch their product. In order to stay alive they must reach critical milestones that are set by the investor.
For these companies, the equation is simple “Time = Money”. Delays in reaching those goals have long-term consequences that can kill the product before it ever reaches the market.
For Instant Cleanroom Solutions clients, the answer is to rent a mobile cleanroom.
These self-contained, fully-functional, custom-configured cleanrooms are built into specially designed semi-trailers and can be delivered on-site to nearly any location with a parking lot or loading bay in a matter of weeks.
How long of a wait is too long?
Even large-scale commercial operations can run short on available cleanroom space. Existing cleanrooms being already fully committed to other products, or being down for upgrades and renovations are just two reasons why a company can be caught short when there’s a critical need.
Not all businesses can afford to wait the 12-18 months needed to get permits and build a new cleanroom facility.
Not only is there a chance that a competitor can be first to market with a competitive product, but there is also the financial pressure of money being spent “just waiting around.”
A burn rate of $1,000,000 a month can quickly add up, and the cost of the delay might exceed the cost of a new cleanroom entirely. This poses particular risk for those businesses reliant on investment from venture capital or similar funding but also can pose a risk for large companies with R&D budgets.
By contrast to a 12-to-18-month lead time, a pre-certified cleanroom trailer can be delivered to a manufacturer’s campus within weeks depending on configuration. And, once it has been connected to local utilities, it can be ready to begin IQ/OQ in mere hours.
Even large-scale commercial operations can run short on available cleanroom space
Instant Cleanroom Solutions’ mobile cleanrooms can provide compliant space ranging from 225 to 350 sqft, shipped with Biological Safety Cabinets, a custom layout, gas supply lines, tight temperature and humidity control can be connected to create a bigger footprint.
Cleanliness standards are available from ISO 5 (EU Grade A) to ISO 8 (EU Grade D) and can meet CFR Title 21 cGMP or many other required standards.
Further, a cleanroom’s mobility itself adds another layer of financial benefits. Rentals can be extended month to month should the situation warrant it.
And, when the renovation project finishes the testing or development phase and the need for the additional space has passed, the trailers are removed and there is no further charge – unlike a cleanroom structure which has recurring costs even when not in use or even underutilised.
Who benefits?
While any business that needs short-term cleanroom space stands to benefit from renting a mobile cleanroom, those companies in industries which are particularly time-sensitive have the most to gain from doing so in addition to companies undergoing renovations.
Both start-up and established biotech and pharmaceutical businesses must watch the clock, watch their burn rate, and watch their competitive advantage.
Typically, the only other option when trying to get a product to market without having a clean room is to contract a third-party facility, or Contract Development and Manufacturing Organisation (CDMO).
This leads to any number of challenges any one of which can essentially leave the company falling behind a competitor or unnecessarily burning valuable funds.
Firstly, there’s the matter of timing. This plays out in the question of how soon you can even get on their schedule. And, if the project runs longer than expected, is there another customer already booked for those additional dates?
Not all businesses can afford to wait the 12-18 months needed to get permits and build a new cleanroom facility
Outsourcing to a CDMO sacrifices your control over production schedules. This could cause the project to pause at a critical moment. There are also the challenges associated with IP control, not only during the development stage but also at the end of the contract with the CDMO.
Re-learning how they built your product will likely be extremely challenging.
By contrast, the mobile cleanroom doesn’t require outsider involvement in the research, development, or production phases. Instead, the company’s own staff is employed in the work, and access can be closely controlled and monitored by the company.
Further, because the mobile cleanroom arrives in turnkey condition, the staff can focus on getting started on the science.
It is impossible to understate the importance of being able to control the entire research process. As stated above, the people working on the development are the company’s own trusted employees.
This reduces operational friction at a time when efficiency is critical. For these reasons as well as the ability to be on-site with the company’s main operations, any product issues discovered can be addressed in real-time and face-to-face with other team members, rather than relying on remote conferencing or travel to and from the CDMO site.
Turnkey means just that
Making that step from the pre-clinical to clinical phase of testing comes with increased requirements upon what facilities are used.
This is laid out within Title 21 of the Code of Federal Requirements (CFR) which layout the FDA’s Current Good Manufacturing Practices (cGMPs).
The in-house facilities of a company may have been able to meet the lower requirements to this point, but are not compliant with the elevated standards needed to proceed.
At this stage of development, the product and company can’t afford the delay that comes with making the required upgrades.
When a client calls Instant Cleanroom Solutions about reserving a mobile cleanroom, among the first questions the ICS representative will ask, is what equipment and configurations will be required to meet the client’s needs.
a pre-certified cleanroom trailer can be delivered to a manufacturer’s campus within weeks depending on configuration
Mobile cleanrooms can be configured to include double-wide doors, anterooms for proper gowning procedures, heavy-duty climate control systems capable of maintaining required internal temperatures despite the changes in the weather outside. Onboard power supplies can be mounted to protect in case of power failures.
Additionally, Instant Cleanroom Solutions ensures that the mobile cleanroom meets the standards required and provides documentation needed to certify compliance with cGMP or other industry standards necessary to meet regulatory approval.
All of this combines into increased operational security, less financial risk and proper assurances to all stakeholders.
And, of course, a successful product and lower risk and fiscal responsibility all provide a positive effect upon the company’s bottom line and reputation.
