5 Things to Consider as You Graduate From an Incubator
Guest Blog By Michelle Paul, Business Development Officer, Cummings Properties
An incubator setting can be an ideal place to establish a biotech business. Once your startup has gained momentum, however, it will be time to leave the incubator community and grow the business in a dedicated facility. Labs working with genomes or diagnostic testing, or otherwise handling genetic material, may also find themselves compelled to transition to a space of their own due to secure storage requirements under Clinical Laboratory Improvement Amendments (CLIA) regulations. Having worked with numerous lab-based businesses preparing for a crucial step to independence, our firm has compiled some key factors to consider in advance of your move.
One benefit of seeding your business in an incubator is the ready availability of industry-specific apparatus. Because any equipment, tools, and materials you do not own will remain at the incubator, you will need to purchase the supplies necessary to your day-to-day operations prior to transitioning to your new space. Plan ahead and complete a thorough inventory of the implements and chemicals your staff uses each day. Add to this list an exhaustive accounting of equipment that is used less frequently but essential to have on hand such as waste storage containers, retinal showers, fire extinguishers, and other safety apparatus.
Think about your facility’s needs. Beyond fume hoods, benchwork, and makeup air units, consider whether your lab will require upgraded power, backup power, high ceilings, or a loading dock. Then there are potential staff needs such as parking, private offices, or a conference or break room.
Leasing a space with existing infrastructure will accelerate and simplify your transition. If a buildout is necessary, however, choosing a commercial real estate firm with comprehensive services, as well as in-house design and construction capabilities with lab space buildouts, can also be an effective way to expedite your move.
Permitting and Regulatory Compliance
Prior to touring a potential site for your lab, confirm that the area is zoned for laboratory and research and development functions. Be mindful, however, that you will still need to apply for various permits from the local municipality and other entities. If you are working with flammable materials, for example, you will need to obtain a permit for flammables from the municipality’s Fire Prevention Office. Operating a lab without first obtaining the required permits and licensure can result in substantial penalties. MassBio’s BioReady® ratings are a helpful resource for identifying municipalities dedicated to supporting the life sciences industry with streamlined permitting, robust infrastructure, and pre-permitted biotech sites.
As technology continues to advance, so too do the federal and state regulations enacted to protect personal information. As you plan your move, make note of the technological and space-related considerations that will ensure that you remain in compliance with HIPAA and CLIA. Firms that handle sensitive personal information may be required to contract with professional shredding, specialized data management, or cybersecurity services. The recent acceleration of genomic therapies and diagnostic and genetic testing has had implications for CLIA, whose regulations may also require that you budget for additional lab square footage to build secure, locked suites for genetic or personal information storage and security.
Waste Removal and Certification
Take an inventory of the materials your lab uses, as well as those your staff disposes of, and consult the EPA guidelines to determine how they are classified. If your work generates hazardous waste, you will need to not only have the means to segregate and store it but also contract with a professional waste removal service.
Labs that use a human workforce must also employ a certified industrial hygienist to attest to the safe conditions of the work environment. Because air sampling and instrumentation are among the audit’s key focuses, this will be where careful infrastructure and equipment planning will pay dividends.
As you analyze your readiness to emerge from your incubator, be sure to consider available funding. It will be important to budget for expenses related to equipment, supplies, and certification among other potential services. In addition to these costs, note that lab spaces may require three to six months of rent (or more) upfront for a security deposit. Educate yourself on the lump sum costs of a potential new facility to ensure you are financially prepared for the move.
The topics discussed in this blog post are not intended to be representative of the complete list of factors one must consider when relocating a lab facility. Please consult available government resources for the prescribed procedure to safely relocate equipment and chemical, radioactive, and biological materials.