As many biopharma and life sciences companies have experienced a sharp increase in demand for new products and technologies in 2020–2021, our new blog series ‘Challenges of Rapid Growth’ explores common growing pains and provides helpful CQV tips.
While greenfield development projects grab the headlines with their modern designs and expansive grounds, new facility construction isn’t in the cards for many biopharma and life sciences companies.
For one, finding the right real estate for a new build can be both time- and cost-prohibitive. And when demand for a product is high and the market is waiting, time certainly isn’t on your side.
Repurposing an existing space to manufacture a new product or to increase production efficiencies might make the most sense in these time-critical scenarios.
Consider these tips if you’re looking to expand operations within your existing square footage.
Considerations for Expanding Manufacturing Operations Within an Existing Footprint
Take Stock of Your Existing Facilities, Utilities, Systems, and Equipment
What aspects of your expanded operation can your current space support? Start with a strategic gap assessment to determine which equipment and systems are suited for your new production goals and meet today’s regulations and industry guidance and are suited for your new production goals. From there, you can prioritize upgrades and replacements as needed.
Taking inventory of your current setup can save you from unnecessarily replacing items that are still in good working condition. Additionally, a close inspection of these components can also prevent repurposing items that will later be identified as outdated or insufficient during qualification.
Save Space with Innovative Equipment and Technology
Even if some of your existing equipment could work in your updated space, is it the most efficient use of energy and space? Newer equipment will typically generate considerable utility cost savings, often making up for the initial investment over the long term.
On top of the financial benefits, a newer piece of equipment may also free up valuable floor space or allow you to reconfigure the layout to enable more production capacity.
For example, single-use systems offer many time and cost savings, including decreased energy, water, chemical, electrical, heating, and air conditioning usage; lower cleaning and sterilization expenditures; and a reduced physical footprint allowing companies to operate in smaller facilities.
Evaluate Current Production Needs and Plan Accordingly
If your expansion goal is to increase production of an existing drug or component, consider if you will need your facility to maintain an operational state during the renovations.
Do you have enough supply to continue meeting market demand during the anticipated renovation downtime? If not, can you ramp up production ahead of the planned downtime to build an adequate supply?
If maintaining operations during construction is your only viable option, it can be done. However, much care must go into project planning and execution to ensure the working production lines are not contaminated or disrupted by the ongoing construction.
Are Your Facilities Ready to Meet Demand?
When repurposing an existing facility, it’s critical to align all parties involved, plan for all equipment and systems needed, and ensure engineering designs are accurate and set to meet cGMP requirements.