BioPharma Boom: Unique Challenges in Technically Complex Spaces

by Kevin Chronley

The biopharma industry is experiencing a boom, which is a prominent driver behind the growth of local area biopharma facilities. Companies are developing technically complex space and fueling an impressive volume of real estate growth.

Additionally, improved health care for patients and attractive economic objectives accelerate schedules. These fast-track expectations have pushed a massive effort to adapt to “office to lab renovations.” As this innovative industry evolves, real estate developers and the construction industry are rapidly mobilizing to support the growth. The proliferation of clean space to support this boom has several contributing factors:

• • Universities: In the Boston/N.E. area, the high concentration of higher education institutions provides the critical trained workforce necessary in this STEM-oriented field.
  • Collaboration and Diversity: High concentrations of the biopharma workforce promotes collaboration, accelerating ideas, and supporting innovation.
  • Innovation: Emerging therapies such as cell and gene modifications, including the mRNA vaccines, have led to the need for new technologies, investments, and facilities.
  • Single-Use-Technologies (SUT): Innovation regarding process development in SUT has impacted approaches for compliance with regulatory requirements and driven smaller, less costly, operationally efficient, and flexible facilities.
  • Flexibility: enhanced investment funding for biopharma facilities, knowing there is a robust pipeline of candidate applications.

The combination of architectural fit and finish to support clean space requirements, intensive utility infrastructure, HVAC – air pressurization schemes, waste, and structural are all challenges of biopharma facilities. The unique/regulated aspects need to be understood, planned, and addressed. With renovations, understanding existing conditions is critical. As such, unique technical and clean space requirements can include:

• • Design Intent: understanding user requirements and engineering specifications. The mix of innovation, variety of lab/process equipment, and regulatory/code requirements are factors behind the highly complex nature of these unique, cleanroom spaces.
  • Architectural Fit and Finish for Cleaning: materials for cleaning, including appropriately specified chalking, lighting fixtures, wall, and flooring.
  • Mech/HVAC – Clean Air Validation: Specifying the clean air criteria, temp, humidity, air changes, filtration criteria, and air pressurization scheme is essential to achieve the design intent and validation for classification. Particular attention to exhaust equipment, such as fume hoods, vented chemical/flammable or hazardous storage cabinets, or other exhaust equipment is essential.
  • Waste Management: addressing waste management, both operationally and for code compliance. Be alert to potential underslab/floor piping requirements. The segregated discharge waste collection or metering/treatment systems can impact permitting, budget, and schedule.
  • Intensive Utilities: The unique facility infrastructure, sustainability, and reliability must be understood. Additionally, planning the density of power capacity, teledata, UPS/E-power, gases, process, water, and cooling is critical.
  • Structural: Floor loading and extra floor-to-ceiling heights need to accommodate equipment and the associated utility infrastructure distribution.

The evolution of the biopharma industry toward higher titers, smaller volume manufacturing processes, and SUT has dramatically impacted the requirements of these facilities. These smaller, less costly facilities require less HVAC, cleaning systems, and qualified water capacity, facilitating a move toward standardization. Standardized user requirements for clean space facilitate the integration for modular applications, which enhance schedule compression, budget certainty, and predictable outcomes. In summary, an integrated and collaborative approach to understanding the unique challenges for clean space is a more successful method to achieving expected results.

Kevin Chronley is vice president of A/Z Corporation.