Rapid Acceleration in Technology for Life Sciences Quality and Manufacturing

We have built technology for life sciences quality and manufacturing for more than 25 years and I have been involved in that effort for 19 years. It wasn’t until 2014 that we realized the why behind what we do and it wasn’t until 2020 that our mission became crystal clear to everyone on our teams.

We bring life changing products to more people sooner, and we have stated our mission in both serious terms (bringing life changing cancer treatments to more people sooner) and less seriously (bringing chocolate to more people sooner). But last year, as we watched our customers try to get vaccines, tests, personal protective equipment (PPE), ventilators, and other pandemic related products to the world, our mission has become deeply personal.

For many of our customers, every day a product release or critical product improvement is delayed because of ineffective manufacturing, quality, or compliance processes, people who need access to these products suffer. It isn’t easy to produce high stakes healthcare products. Quality standards are exacting, and regulatory compliance is complicated. Add high volume manufacturing needs and demands for speed to market, and the challenge becomes awesome.

The pandemic has shown how important our healthcare product design and production capability are to the world. A key to accomplishing both is the ability to adapt. It was humbling to watch our customers respond to a global emergency by adapting and being flexible in ways nobody could have imagined in late 2019.

There are so many extraordinary examples to choose from, but space limitations only allow me to provide a few. A European customer manufactures single-patient isolation pods that allows for the safe transport of highly infectious patients. In early 2020, as the number of COVID-19 cases continued to climb at an alarming rate, the company saw demand for the pods grow by almost 18 times in just two weeks. ⁽¹⁾ In the face of factory closures, they were able to use MasterControl’s solution to work remotely and collaborate with suppliers to ensure specifications were met and address quality issues as the arose. The need for the pods continues, and in late 2020, they were deployed in Canada. ⁽²⁾

Another customer, a pharmaceutical compounding facility, started their digital transformation on the cusp of the pandemic, and worked to transition away from a 15-year-old legacy system. When dexamethasone, a steroid, was found to help seriously ill patients fight COVID-19, the customer was prepared, and they responded quickly to the rapid increase in demand. Their cloud-based QMS helped them align quality processes and coordinate qualifying and auditing teams across four continents.

These customers and everyone we had the pleasure of working with in 2020, were able to pivot rapidly, and their response would not have been feasible without innovative advances in data manufacturing.

We are witnessing a great acceleration in the production of life changing products. At about this same time last year, COVID-19 was declared a pandemic. Today, an effective vaccine is on the market and being distributed around the world.

There are moments in time when technology and innovation leap ahead, and more is accomplished over just a few short years than in all the decades that came before it. Today, because of smartphones, Americans take more photos every two minutes than were taken throughout the world in the 19th century. ⁽³⁾ For thousands of years, humans dreamed about being able to transplant organs to save lives, but this feat wasn’t accomplished until the first successful transplant in 1954. ⁽⁴⁾ Now, approximately 150,000 organs are transplanted every year. ⁽⁵⁾

Our industry is on the verge of similar transformation. Recent advancements in technology are abundant – and it’s only the beginning.

As life sciences companies invest more in digitizing and working from a single platform, the potential of quality and product data is going to be unlocked. Artificial intelligence (AI) will analyze the data to identify and report on patterns and emerging relationships. Insights that weren’t possible before, are going to be available. Ultimately, through machine learning and other AI-enabled tools, it will be able to predict and prevent quality issues, which is the key to eliminating the friction and cost of quality and compliance.

These critical advancements will be instrumental in moving toward a future when issues with manufacturing, quality, or compliance won’t cause delays – people will have faster, more affordable access to products that reduce, alleviate, and shorten disease and human suffering. MasterControl is dedicated to making this happen by driving innovation and speed to market. It is a privilege to work with our customers during this exciting, rapid acceleration in technology for life changing products.

Sources:

1. Fast track needed for safe COVID-19 patient transport, AirMed&Rescue, November 2, 2020.
2. Canada launches EpiShuttles in the fight against Covid-19, AirMed&Rescue, November 12, 2020.
3. In 2014 we took 1tn photos: welcome to our new visual culture, Nicholas Mirzoeff, The Guardian, July 10, 2015.
4. Historical Overview of Transplantation, Clyde F. Barker and James F. Marmann, Cold Spring Harbor Perspectives in Medicine, Retrieved in February 2021.
5. International Report on Organ Donation and Transplantation Activities Executive Summary 2018, Global Observatory on Donation and Transplantation, Retrieved in February 2021.