PAK BioSolutions provides comprehensive solutions for end-to-end continuous manufacture of biopharmaceuticals. The company aims to meet growing demand for automated equipment and consumables in this space to enable implementation of continuous processes in both laboratory and GMP facilities.

The company’s key technologies include the Pilot PAK, an automated system that operates four continuous purification stages simultaneously, and a solid single-use flow kit that is used with the system. PAK BioSolutions was awarded its first patent on March 31, 2021 for a “Therapeutic Protein Flow Kit for a Continuous Purification System” by the U.S. Patent and Trademark Office (USPTO), U.S. patent 10,981,950.

In addition to the company’s product offerings, consulting services are provided. PAK’s engineers are available to provide technical seminars, perform individualized technical and business case evaluations, and assist customers with implementation of continuous manufacturing processes.

Interview with Celeste Amadei, Product Manager at PAK BioSolutions.

Easy Engineering: What are the main areas of activity of the company?

Celeste Amadei: We at PAK BioSolutions spend significant energy on R&D for new products to offer the market. We also have had to ramp up our manufacturing to meet growing demand. And, of course, with any technology you have to stay up to date with the industry: new practices, new regulations, new research, etc. 

E.E: What’s the news about new products/services?        

C.A: We will soon offer a full range of PAK system sizes. The benchtop-scale PAK PD can process 2-10L of cell culture per day while the commercial-scale PAK K Series can process up to 20,000L of cell culture per day.

The PAK Pilot covers the middle range of 50-500L of cell culture per day.

E.E: What is the state of the market where you are currently active?

C.A: Availability of capital and investment in the biopharmaceutical industry as a whole has been down since 2023. However, sentiment out of the JP Morgan conference and other industry events is that the market is expected to improve this year.

E.E: What can you tell us about market trends?

C.A: The market for continuous manufacturing is in its infancy but growing significantly every year.  Most large biopharmaceutical companies are testing continuous manufacturing at some level.  While a commercial biopharmaceutical product has not yet been approved with a continuous manufacturing process, there are GMP facilities with some continuous production methods.  With the FDA’s support of continuous manufacturing, as evidenced by their investment in these technologies and published statements, we expect more and more adoption by companies from development through commercial applications.

E.E: What are the most innovative products/services marketed?

C.A: One could say that our entire business is innovative. We have patented technology that completely revolutionizes the way biopharmaceuticals are produced, shrinking facilities by 75% and increasing productivity 4X. Our systems are fully automated, eliminating possible points of error in the manufacturing process. Standardizing and being able to scale these types of processes helps regulators understand production methods and evaluate applications faster. 

E.E: What estimations do you have for the beginning of 2024?

C.A: 2024 is shaping up to be a very important year for PAK BioSolutions. We will be launching our new benchtop-scale PAK PD system, attending more industry events than ever before, and growing our workforce with new hires and new positions. We have already rolled out automation updates for our systems in Q1 and plan to deliver a record number of systems this year.