Creating a commercial stem cell production facility

24Jun

Biopharmax is an engineering company that focuses on the pharmaceutical industry. It has designed and constructed over 100 facilities in 14 countries around the globe and is actively present in Europe, China, India and the Middle East.

The company designs, builds and validates pharmaceutical facilities of the highest level and has a proven track record of handling and addressing the most advanced biotechnology processes and products.

Biopharmax integrates Rockwell Automation products in several of the customer facilities it designs and constructs, including a recent project for Pluristem in the field of Stem Cell growth and final therapy dose production. Pluristem’s requirement is for Biopharmax to set up a state-of-the-art facility that can produce final Stem Cell therapy products on a commercial scale.

According to Solomon Gahtan, Business Development Manager at Biopharmax, “the company has a unique model where it will design a factory from the start, construct it in its entirety and then validate it to make sure it is prepared for regulatory approval, such as FDA. We hand over at the approval stage and then take responsibility remedying any issues.”

Not all companies work this way; some will use a designer and then various sub contractors. In this instance you often get a dispersed control system for each of the individual elements of the factory. Biopharmax takes the plant as one, including the HVAC, plant utilities, critical systems, such as Purified Water (PuW), Water For Injection (WFI) and Pure Steam (PS), and other production elements.

This way, the company can better protect sensitive product batches from any variance in the plant conditions, such as room temperature, humidity and cleanliness. It can monitor the various parameters and, when required, enhance the necessary remedial action activated by the control system itself. This may turn out critical for protection of the product batches during the production stage. It also allows better optimisation of energy consumption by the HVAC system and reduces unnecessary OPEX.

Stem Cell products are extremely difficult to grow and produce. Pluristem holds many patents for processes and devices that would address the growth process as well as final dose production and filling. Such facilities have to adhere to stringent FDA and EMEA regulatory standards.

The new facility is designed and constructed from scratch within an existing building. The project scope includes HVAC and clean rooms of the highest A and B classes, plant utilities, critical utilities, such as PuW, WFI and PS, as well as Buffer and Media production.

Pluristem is a start-up company and with this project takes a leap from the R&D stage to commercial-scale production. Being so, CAPEX as well as the OPEX optimisation are a major challenge for the designer, and it is extremely important to provide the client with these advantages. Furthermore, future expansion plans have to be addressed and the solution must facilitate a seamless future expansion.

Stem cells are currently the pinnacle of the biotechnology industry and, being a relatively new field, require special care as process and product are highly sensitive. The growth process is relatively long and may last a few weeks, which increases the risk and financial impact of batch loss due to any failure in the plant conditions.

The system is based around an Allen-Bradley ControlLogix controller. Running over EtherNet/IP and a combination of remote I/O and serial link communication gives Biopharmax the ability to meet these challenges successfully. All service areas are of grade C clean rooms, while production is in grade A and B with a minimum foot print. This significantly reduces energy consumption as well as CAPEX. Another very important design feature is the full separation between production suites to avoid risk of cross contamination.

EtherNet/IP between the controllers and the Variable Speed Drive control, as well as serial link communication with the FFUs, allow the system to analyse the highly detailed data received from these components and activate corrective measures where required. This significantly increases the system performance in response to changing conditions as well as helping to optimise energy consumption. Furthermore, SMS alerts have been introduced to provide the staff with the ability to react instantly to any undesired variances.

Remote I/O has been chosen not only for ease of implementation, improved speed and higher reliability, but also to help towards easy integration of future expansion while negating unnecessary handling of infrastructure that may disturb smooth plant operation and cleanliness.

“As far as we know, this project has led to the creation of the most efficient and cost effective facility in the world for cell therapy,” Gahtan stated, “with Rockwell Automation, we have been able to develop a fully integrated control system for Pluristem that takes into consideration the different elements of the plant. This solution is able to react very quickly to any undesirable variables and provide the correct alarms and remedial action, helping to protect an extremely valuable process and product.”

The plant has been designed with separate production suites to avoid cross contamination. e could minimise the footprint and the high energy consuming grade A and B clean rooms. This has led to a very cost-effective solution.

“When we design a plant,” Gahtan continues, “we always look at the possibility of expansion while still using a control system that will control the entire plant including the future expansion and we have well catered for this future possibility.”

He concludes. “We can always communicate with Rockwell Automation on specific problem solving and the company has been a great help when it comes to finding and building solutions for customers. We can also rely on them in terms of supply and logistics.”