Start-ups – Moving out of the Incubator into a New Pilot/Manufacturing Facility

Start-ups – Moving out of the Incubator into a New Pilot/Manufacturing Facility

04/17/2018, 1:30 PM - 2:15 PM

Technical Conference Stage 1, Booth 1076, Exhibit Hall

Language:
English

Start-up companies often have their beginnings in a crowded flex space. After years of research and testing, they finally developed a viable product. This is the stage where it becomes necessary to take the company to the next level and move into a dedicated facility. The list of questions on how to accomplish this vital step in the future of the company seems endless; yet, no matter how long this list becomes, it likely has not captured all the requirements. The most logical strategy is to solicit the assistance of a commercial Realtor to identify potential locations. But what are the necessary elements to consider in the search for the right facility? Who are the right people to engage? The knowledge and skill to develop a new product is very different from understanding the workings of a pilot or manufacturing facility. Finding the resources with the knowledge to aid in your facility selection extends beyond your Realtor. Proper due diligence requires the assistance of those that can translate the needs of the process to the optimal facility from a layout, functionality, reliability and cost perspective. Communicating the process and equipment knowledge to develop a Conceptual Layout and Basis of Design is the next step in the process. These documents need to be somewhat flexible in nature, as they are intended to identify spaces and requirements that will be tailored to fit into available sites. They are also the basis to obtain a reliable cost estimate in order to ensure proper funding is secured prior to committing on a location. The development of these documents provides the criteria for the facility selection process. The complexities associated with life science facilities presents challenges and requirements that may not exist in all commercial facilities. Overlooking these special considerations can have a significant impact on the delivery and cost of the facility. Proper space planning for all aspects, such as office space, lab space, processing rooms, mechanical equipment and other operations, will quickly determine if a facility has adequate square footage; but further considerations must still be made. Planning for additional space to account for short term growth should be considered and weighed against the need to perform additional construction and the added disruption to operations associated with a secondary move. Other less obvious facility considerations, such as building height, roof or floor loading, general accessibility and utilities, can be cause to eliminate a building from the list of prospective locations. Lab and manufacturing equipment are often utility intensive and can drive the need for upgraded services. The costs associated with these upgrades can be significant and must be considered during the selection process. The availability of additional services and the timing required for utility companies to provide them can impact schedule considerably. Assessments of waste and emissions must also be considered, as permitting for these items with local authorities can create significant delays. Ultimately, funding is secured and a location is selected. The design, construction and qualification of the facility are completed and the transition is successful. Many times, companies attempt to self- perform these services, developing their own concepts, to avoid the expenses associated with hiring architects, engineers and commissioning agents with this expertise. The financial impact associated with the build-out of a facility based on incomplete assumptions can be costly, but is often times secondary to the impact resulting from delays on product submission or launch. These outcomes can have a significant impact on the health and success of a young company. Getting the right team on-board early in the process is essential to success.

Contributors

  • Mark Bellino

    Speaker

    Director, Pharmaceutical Services

    Precis Engineering, Inc.

  • Josh Capparella

    Speaker

    Director, Project Management

    Precis Engineering, Inc.

Type of Session

  1. Type of Session
    Session

Learning Objectives

  1. Learning Objectives 1. Defining Space Requirements Programming a lab or manufacturing facility requires the user to define the needs and wants for that space. Collecting and sorting through each user’s requirements is a time-consuming process that is necessary to developing efficient and effective operational flows. The user’s understanding of what does and does not work in a current space is valuable knowledge, although translating this into the optimal space design requires more. Experienced designers will look beyond the user’s experience to capture space requirements fully. Assisting the user in understanding the needs and relationships associated with each area aids in capturing additional requirements which are documented in room criteria sheets. Space planning and adjacencies to accommodate building flows are identified, arranged and fine-tuned to create several conceptual space layouts. The concepts are reviewed and the preferred option is selected for further refinement. 2. Defining Facility and Utility Requirements Facility design is not limited to considerations for operational activities. Architectural finishes and infrastructure requirements have a considerable impact on lab and GMP space fit-out cost. Concessions with regard to fit and finish are often subject early value engineering exercises. Facilities and utilities infrastructure can range from 40 to 50 percent of the project cost, and if not accounted for, can result in significant overruns. Available general utilities such as electric, gas, water and sewer are important factors to consider. Insufficient utilities can result in large expenses when not taken into consideration during facility selection and can cause significant delays if additional services are needed. Utility infrastructure requires a significant footprint; understanding how and where it is located in the facility can be complex. 3. Understanding the Impact of a Properly Designed Facility Facility design will have a long-term impact on operational efficiency. Ineffective layouts without consideration for movement through the facility, space adjacencies, technical spaces and space for future growth can cause significant issues. Layouts which do not permit efficient operation can limit productivity, increase risk associated with cross-contamination or mix-up, or even result in higher than expected operational costs. Proper facility design will have a significant impact on start-up companies. Optimizing the space and making the most of limited capital is crucial to ensuring success.

Categories

  1. Track
    Optimizing Facilities through Innovation & Technologies

We use cookies to operate this website and to improve its usability. Full details of what cookies are, why we use them and how you can manage them can be found by reading our Privacy & Cookies page. Please note that by using this site you are consenting to the use of cookies.