Growth of Biotech!

With the opening of the new, state-of-the-art Gallogly Hall, I would like to take the opportunity this fall to blog about my experience in the biotech industry.  My goal in writing this will be to survey the topic of biotechnology, discuss the opportunities for engineers to make a difference, and present some of the opportunities I have had with my employer, Smith+Nephew, a global medical technology company.

It is my biased opinion that we live in a truly exciting time for the advancement of health care.  According to research done by Pertry et al, the number of commercial biotechnology products continues to increase every year.  In order to meet the rising expectations from the market, the industry requires more technical experts than ever.  The fundamental principle of the industry is to convert a biological process into useful medical therapy.  While small molecule drugs still dominate the United States market in terms of quantity of products and goods sold, the pharmaceutical pipeline contains hundreds of thousands of innovative solutions utilizing biological-based medicines.

As the product pipeline grows, there is a growing need to characterize and improve the commercial-scale technology in the biotech industry to meet demands.  I have come up with a list of what I believe are key developments needed to sustain industry growth in the next decade.  I encourage you to think about your technical background and how you might solve some of these challenges:

1. Continuous manufacturing.  

Traditionally in biotechnology, products are made in batches.  Finding a technology fit for the continuous manufacturing of high-volume products could lead to serious reductions in the cost of manufacturing.  Engineers will be challenged to design novel systems, equipment, and processes for converting or creating continuous manufacturing for biotech products.

2. Scalable Technology.  

Not all products can be converted or originated under continuous conditions.  In these cases, it is often more practical to specify the most economical product path and scale-up to meet the annual production forecast.  Electrical and mechanical concerns must be addressed in order to specify the scale.  Engineers involved with scale-up will be challenged to understand the scientific principles occurring at the small-scale and apply engineering principles for creating an adequate scale-up model.

3. Single-Use Technology vs. Energy Reduction.  

In biotechnology, specifically protein production, it is often necessary to sterilize the manufacturing systems in order to avoid cross-contamination of the desired product.  These processes incur high utility demands.  It is often an economical decision on whether to implement “one-time-use” components in the process or put the system through cleaning and sterilizing at a defined frequency.  The challenge for engineers, on both sides, will be to analyze the economics and pose solutions that make the most sense for the product.  This includes characterizing novel materials.

4. Briefly on a few more:

Improving the logistics of Cell and Gene Therapies will be a must – especially for products derived from the patient themselves!  Allogeneic therapies appear to be the de-facto solution to this problem, but this field is very new with only one FDA approved product in the United States.   

The digital transformation of biotech plants is rapidly approaching.  Automation and Control System advancements will be critical to ensuring autonomous processes can repeatedly obtain the same result.

Reducing the time to market is a growing consideration of biotech companies that wish to maximize the patent cliff of their new products.  Research engineers will be challenged to strategize aggressive development timelines that minimize the time to market while maximizing manufacturing flexibility.

In the spirit of Biomedical Engineering, combination products of both medical device and biological drug origins will be a growing field requiring engineers from all disciplines to design and optimize products to meet patient needs.

Smith+Nephew has been providing health-care solutions for over 160 years.  Originating in Northern England in 1856, Thomas James Smith & his nephew began a family pharmacy selling cod liver oil. Over time, the company has acquired and expanded its business into three core franchises:  orthopedics, sports medicine, and advanced wound management.  

No matter which franchise, our teams are driven to provide technology that takes the limits off living and help other medical professionals do the same.  Two words bring together everything we do:  Life Unlimited. 

In my four years with the company, I have had the good fortune of traveling internationally and seeing the impact our products have on our customers and their patients globally.  As a process engineer, my job is to find the most efficient, economical way to manufacture a wide variety of the products our customers need without jeopardizing the safety, quality, or efficacy of the product.  I have been involved in projects improving current products and designing fascinating new ones.  Although the industry is challenging and complex, I have the comfort of leaving every day knowing that my work makes a difference.

Author: James Guerra, Chem E & Math '16
LinkedIn: JamesGuerraEIT