Speed to Market… What if you could have speed and simplicity to market?

Within the world of new drug development, moving from molecule to fully FDA approved drug is complicated, time consuming and expensive. Estimates put the average cost to develop a new drug from discovery to market anywhere between $1.3 billion and $2.8 billion. As a molecule progresses its way from an idea, through certification, and to its end user, it will move through strictly regimented research processes that are overseen by the FDA. The drug will start out as a hypothesis, and some very initial bench-top work will be performed to test for general efficacy. From there, greater scrutiny will be placed on efficacy, safety, dosage etc. The drug will move into pre-clinical testing, then onto Phase I, Phase II and Phase III clinical testing, with the FDA sometimes requiring Phase IV testing. In total this process can take up to 10 years.

Developing a drug takes a small army of scientists, innovators, investors, quality oversight, and leaders. It also requires specialized real estate in some expensive biotech hubs. Together, the talented people and expensive real estate place small biotech startups at the top of the list of expensive start-ups.

Why does speed to market matter?

Speed to market is often prioritized and spoken about in the life science startup community. Every company has a cash burn rate - the cost to do business. Many biotech start-ups do not have sales yet and rely solely on investor money. Let’s say XYZBio, a cell therapy company, has a burn rate of $2,000,000/month and they just secured another round of investment for $20,000,000. The math is simple, they have 10 months to survive until the next round of investment. If they run into delays and slip past the 10 month deadline they will be on borrowed time (and money) making it more difficult to secure another round of investment.  However, if they are able to reduce their development time to 5 months they would have left over cash, and future investors would look at the XYZBio more favorably.

Early phase Biotech companies are faced with the option to outsource to a contract manufacture (CDMO) or contract research organization (CRO). These serve a valuable purpose in the industry; however, they are very expensive and might not have open slots for 12-18 months. The alternative option, called the platform approach, is to develop the platform required to move your drug through the development pipeline. This mandates staffing a team, securing a building, and designing, building and qualifying a cleanroom. This process typically takes 14 months and millions of dollars if you are moving quickly and building on a budget. For XYZBio, 14 months of waiting can easily cost $28,000,000 in wasted staff and building costs. That also doesn’t include the $1-5 million spent building a cleanroom.

Going from the preclinical to clinical phase? What manufacturing direction is right for you?

A major change that any drug developer will notice as they step from preclinical studies to clinical trials will be the need to abide by the FDAs Current Good Manufacturing Practices (cGMPs). These drug quality related requirements can be found within Title 21, the FDA portion of the Code of Federal Regulations (CFR). The cGMP requirements can be found within parts 210, 211, and 212 of Title 21 CFR. A primary portion of the cGMPs lay out stringent requirements for the facility design and validation. These facility design requirements mandate a certified cleanroom to meet various micron-level particulate limits, humidity controls, temperature controls, differential pressure requirement’s, surface material requirement’s, and overall room configuration requirements that are all aimed toward limiting the development of Colony Forming Units (CFUs) and other variables that might compromise the safety and efficacy of the drug or medical device.

You can build a cleanroom

Building a cleanroom is likely the most common direction companies chose. If you chose to build a cleanroom you will assess two different options. First, there is the standard construction cleanroom that is built with conventional building materials. These are the most expensive option and take years to design and build, making them an unattractive option for the drug development world that wants to limit their capital expenditure and needed a cleanroom.... yesterday. The primary alternative is the modular cleanroom, designed using prefabricated materials rather than drywall and putty. This option is less expensive, typically takes about 8-12 months to build, and can be installed inside of a preexisting building. Although this is faster than the standard construction cleanroom, 8 months can still feel like and eternity and might be detrimental if bringing your product to market in a timely manner is important. However, modular cleanrooms are fully customized and can be expanded as your operation expands. ICS understands 8 months is still too long and we focus on shortening this timeframe. However, we are often waiting on permits and other governing authorities. For some more simple projects, construction time may take as short as 2-3 months.

You can rent a building with an existing cleanroom

As a company working on developing a new drug, this might look like a great option at first, but it will require a long-term lease on a building that will likely costs millions of dollars over the span of years. It will require your staff to move, adding a relocation cost and risk for employee turnover if the move adds anything over a thirty-minute commute. With less-than-1% vacancy seen in all the major U.S. biotech hubs in 2022, chances are you won’t even be able to consider this as an option.  Landlords seem to be very uninterested in leasing to small companies when they have large brand-name pharmaceutical companies knocking on their door with decades of credit history.

You can rent a mobile cleanroom

A newer option that is proving to be very attractive to the drug development community is the mobile cleanroom. Mobile Cleanrooms come in various shapes and sizes, but most often they are pre-built and certified within semi-trucks. Mobile cleanrooms are the most turnkey and rapid cleanroom option. Often a company will choose to rent a mobile cleanroom while they start to build a modular cleanroom within their facility and then extend the mobile cleanroom rental as their construction project warrants. Mobile Cleanrooms afford a company total control of their intellectual property, best speed to market, maximum flexibility on relocating the cleanroom if needed, and a turn-key solution that doesn’t require inside building space. Some company’s by-pass the building option and choose to rent a cleanroom for the entire duration of the study. Other companies get caught in a lengthy permitting process and choose to bring a mobile cleanroom onsite to bridge to construction gap. CMOs, CDMOs, start-ups and large R&D departments all favor mobile cleanrooms.

You can outsource your development project to CDMO or CMO

You can choose to pass your development project over to a contract development organization. This is a can great solution if you have deep pockets, aren’t afraid of leaking intellectual property, and can get a conversation with a CDMO willing to take you on as a client. The fact is, the contract world is very picky with who they choose as customers. Smaller start-ups will often not be accepted (or put on year-plus waiting list) since the few hundred thousand dollars per month fees are nothing compared to the multi-million per month fees a brand name pharmaceutical company could offer.

What will you choose?

Biotech companies have long been marketed to with suppliers’ products offering speed to market. It is time that they are offer both speed and simplicity on their road to a marketed drug. Options like fully built hardwall or modular cleanrooms are great for multi-year projects for manufacturers with cash available. If that doesn’t describe your timeline, consider a Mobile Cleanroom as a temporary or project-long solution to drive your product to market rapidly and simply.

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