The pace of change in our industry is phenomenal. In January of 2020, the FDA reported over 900 investigational new drug (IND) applications for ongoing clinical studies. Combined with fast-tracking of approvals, this volume of new applications has produced an environment in 2021 where biopharmaceutical companies move at warp speed, and that cadence cascades through the construction projects.
JE Dunn has embraced this new reality with a decentralized, nimble platform that leverages our deep pool of knowledge and resources, providing flexible, solutions-driven teams that thrive on our client’s fast-paced construction requirements.
Your business may be called upon to embrace this reality in different ways. Specifically, this means keeping your team focused on the science while engaging a partner that will focus on efficiency and be cost-conscious about the construction of your facilities, to keep pace with the speed of innovation. Agility has never been more important!
That is where JE Dunn comes in. With deep experience in the construction of science and technology laboratories and manufacturing facilities, JE Dunn’s life sciences team can apply our institutional knowledge to create modern laboratories and manufacturing facilities, compliant with FDA guidelines. Cell and gene therapy companies can focus on what they do best: Science. JE Dunn will focus on the delivery of the facility.
Our experience has shown that the formula for success in construction projects is repeatability combined with customization. Yes, you want to make sure that your facility is designed with your specific needs in mind. You also need to make use of the best construction practices and repeatable processes. Biopharmaceutical progress cannot wait for companies to catch up to advances made in the industry.
Be crystal clear on your end game and have answers to important construction questions. What type of facility do you need for safe, fast, and affordable product development – and how quickly do you want to get product to market? Do you have the knowledge to properly incorporate long lead times for hard-to-get equipment into your construction schedule? Do you have a handle on FDA considerations related to facility approval? These moving parts must work together to ensure speed to market.
Some key considerations in the actual construction process to consider:
This is crucial for safety and quality in life sciences construction. With prefabrication, you can address changing demands for new capabilities without sacrificing speed and mitigate site work risk. Turnaround time is faster when compared to actual on-site construction of these components, and work does not slow down due to weather conditions.
Clean build protocols
With these protocols in place, you can be sure that all areas are thoroughly cleaned (and recleaned) with approved techniques and adhere to Good Manufacturing Practice requirements during construction. This mandatory process controls points of entry, avoids surface damage and prevents contamination.
Commissioning, Qualification & Validation Phase
You must have a system in place to transition building operations from the construction project team to the operations and maintenance team. A seamless handoff is essential for start-up when construction is complete. Prioritization of systems turnover in accordance with the Commissioning Plan (which should be developed early in the Design Phase), is critical for operational readiness.
Usable safety documentation
A safety manual is not much use if it is 600 pages of dense, confusing, and often unreadable technical jargon. You will need a manual written in understandable language(s) if you expect trades people to use it as a resource.
If you are unsure of any part of your project, you will need the confidence that comes from working with JE Dunn’s team of experts, right from the start. Over our combined years in the biopharmaceutical industry, we have successfully mitigated many risks and challenges, to achieve the certainty of outcome. We have taken the best of what we have experienced and combined it with an agile way of working. Most importantly, we have applied lessons learned along the way – to be your indispensable business partner.
Ambitious cell and gene therapy companies know they need the right facilities. They also want to work with a business partner that understands how they function – lean, nimble, efficient, and cost-optimized. That partner is JE Dunn. We listen to understand what is important to you, so that we can deliver your facility safely, with expected quality, timely and within your budget.
Together, we can help you embrace the future of cell and gene therapy production.