by Kevin Chronley
The awe and attraction of a big wave is undeniable, and the life science market has experienced a significant building wave over the past several years. The challenge is determining how it will break and how to read the wave for a great ride versus a wipe-out.
As background to validate and understand the forces behind the life science wave, there is a combination of contributing factors. Analogous to the waves that originate from traveling long distances that evolve over time, some ocean waves crash serendipitously into the coast. Others find that magic sandbar location and hit the timing of a cyclical tide to produce the glorious opportunity surfers desire.
The life science market has a significant volume of new and retrofitted space opportunities, which have similar long developing contributions to creating the wave. The life science wave, particularly in the northeast region, is here and now, but the origins are years and decades in the making.
The evolution of biopharmaceuticals has been developing since the 1980s. A primary driver for exciting innovation that is here and now are the emerging therapies, namely cell and gene therapies, as well as the mRNA vaccines. These therapies have led to new process technologies, facility investments in labs and manufacturing, and the evolution from large single-product facilities to agile small-scale, multi-product cGMP clinical and manufacturing facilities.
The 21st century challenged the regulated life science industry to address the high cost and long arduous time frame to bring products to the market. Additionally, as applicable to the pandemic, the need and flexibility to deliver immediate solutions within the regulatory process is paramount. As such, Single-Use-Technologies (SUT) have been implemented to provide the necessary isolation and containment for process development without the large facility infrastructure, including air, ware and clean space. The SUT alternative for compliance with regulatory requirements has facilitated much smaller, less costly, operationally efficient, and multi-product flexible facilities.
Succeeding in this challenging market requires navigating the rigorous regulatory requirements. Today’s market demands faster and more value-oriented solutions. Overcoming the current economic impacts such as supply chain failures, increasing inflation, and labor shortages is essential.
The strategic planning approach is analogous to the ocean wave surfer and requires agility and adaptation to what the supply chain delivers, including:
- A design process that develops early defined specifications and alternatives.
- Planning to incorporate a flexible approach, schedule, and early funding of long-lead items.
- Integrating the CM and key subcontractors early to provide collaborative input.
- Communicating and coordinating with the vendors and tracking the supply chain.
- Ensuring a quality-managed process for product substitutions.
The exciting life science wave is here and breaking; what this extraordinary ride delivers in terms of the objective of a predictable outcome has the attention of many. However, there are few assurances of the outcome for those without the skills, experience, resources, and flexible approach to adapt, accommodate and achieve predictable results.
Kevin Chronley
Kevin Chronley is vice president of A/Z Corporation.
