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Case Study

 

A Game-Changing SAP Business All-in-One Implementation for Gallus BioPharmaceuticals

by Lauren Bonneau, Senior Editor, SAPinsider | insiderPROFILES

October 1, 2012

For a biopharmaceutical company like Gallus BioPharmaceuticals, production processes, quality standards, and documentation of manufacturing operations have to be precise every time. When the company acquired a commercial facility in 2011, it was tasked with moving the acquired plant onto independent IT systems. To do this, Gallus decided to implement a new business solution from the ground up.
 

The pharmaceuticals industry is a crucial element of today’s economy and society. In 2011, global medicine sales amounted to over $950 billion. Annual spend in the US alone totals well over $200 billion, and about half of Americans take at least one prescription drug each month. Yet, as prevalent as over-the-counter drugs, prescription medications, and other life-saving medicines are in our daily lives, it’s not often that the average consumer stops to consider exactly where or how these pharmaceuticals are produced.

For many people, the image that likely comes to mind is a group of scientists in white lab coats, combining chemicals in test tubes and juggling beakers and microscopes. While this depiction is certainly accurate, the process of developing some of the most promising medicines involves more than just chemistry — there’s an essential biological component as well. Biopharmaceutical companies fulfill this role by growing and multiplying living cells and then capturing the substances these cells produce, such as proteins and nucleic acids, which ultimately form the basis of a biopharmaceutical product.

Gallus BioPharmaceuticals, based in St. Louis, Missouri, is one such company. “We manufacture bulk biopharmaceuticals, which means using living cells to produce medicines to treat diseases and improve patients’ lives,” says Mark Bamforth, President and Chief Executive Officer of Gallus. “We develop processes to manufacture proteins and other products using cells in bioreactors, which we supply as a contract manufacturer to pharmaceutical companies.”

For a biopharmaceutical company like Gallus that works with living cells every day, consistent processes are paramount. The production processes, quality standards, and documentation of manufacturing operations have to be precise and unfailing — every time.

“We have to keep these cells happy, growing, and doing the same thing consistently time after time,” says Steve Kasok, Chief Financial Officer at Gallus. “There’s a little bit of art in addition to a tremendous amount of science in what we do.”

As a contract manufacturing organization (CMO), Gallus does not make products labeled as its own. All the manufacturing the business does is on behalf of other companies that are developing biopharmaceuticals for patients around the world. Gallus offers the expertise to develop processes that will get products to the right quality and quantity for its customers, as well as a facility to manufacture the product.

“Our customers develop the drug and they handle the marketplace, distribution, and clinical trials. They contract with us to help develop the process, provide clinical supplies, and ultimately produce the commercial product,” says Kasok. “And as the product comes out of our facility, it needs to be at current Good Manufacturing Practices (cGMP) standards, and the process needs to be replicable and documented.”

And because the biopharmaceutical industry is highly regulated, in order to supply commercial licenses, health authorities all across the world have to inspect and approve the facility before the first batch of a new product is distributed to patients. “We currently supply products that are distributed to more than 75 countries. If we make a perfect product but haven’t documented it correctly, that product can’t be sold or used — it’s worthless and must be discarded,” says Kasok. “Having a framework that includes a top-quality information technology solution as the backbone for the business is crucial to every single thing that we do.”

           

 

       
“Having a framework that includes a top-quality information technology solution as the backbone for
the business is crucial to every single thing
that we do.”
Steve Kasok, Chief Financial Officer, Gallus BioPharmaceuticals
                                          

The Need for a New Solution

Gallus’ site has a 26-year history of developing processes to make products. “Our organization has tremendous depth and longevity,” says Bamforth. “When customers walk in our doors, they are impressed with what they see in terms of the quality of the facility and the experience of the organization.”

And in the last decade, this history has been one of helping customers by manufacturing and supplying commercial products to an expanding number of countries — currently around 75 countries.

Gallus’ strategy is one of organic growth at its current manufacturing site along with partnerships and acquisitions to support business expansion. In fact, in May of 2011, the company’s St. Louis, commercial facility was acquired from Centocor Biologics LLC (renamed Janssen Biotech), a Johnson & Johnson company.

After this acquisition, Gallus was tasked with removing itself from Janssen Biotech’s business and quality IT systems within 120 days, which meant moving the acquired plant onto independent IT systems. To do this, Gallus decided to implement a new business solution from the ground up. During the evaluation phase of the project, requirements that were defined as critically important included finding a strong, easy-to-use, flexible growth platform that had the ability to scale with the business.

“We needed a vendor in which we had tremendous confidence in terms of its financial viability and willingness to continue to invest behind its product for the long term,” says Kasok.

After performing a cost analysis and taking into consideration that the acquired facility was already running an older version of SAP software, Gallus decided to go with SAP Business All-in-One.

“A key driver behind the choice was that we wanted to use robust, industry-standard systems,” says Bamforth. “10 out of the 10 large pharmas in the world use SAP software, as do 8 out of the 10 largest biotech companies. Using industry-standard systems that are recognized by our potential clients is important to build confidence in the reliability of our operations.”

           

 

       
“Using industry standard systems that are recognized by our potential clients is important to build confidence in the reliability of our operations.”
Mark Bamforth, President and Chief Executive Officer, Gallus BioPharmaceuticals

                                        

Implementing the Functionality

Gallus set a project schedule to complete the implementation in 14 weeks, at which time the business would be removed from the Janssen Biotech systems and up and running with its own independent SAP system. “It’s always a big question mark that companies face when moving to an enterprise-wide system — whether they can complete the implementation on time and on budget,” says Kasok. “We did, and we are incredibly proud of our entire organization’s role in this accomplishment.”

Gallus did not undertake this project alone. The business teamed up with an integration partner to help implement an industry-specific SAP Business All-in-One partner solution (EzPharma by Answerthink). Gallus also elected to contract with a third-party partner to host the solution.

With SAP Business All-in-One as the company’s core system and data backbone, Gallus began to utilize the solution’s capabilities for controlling and finance, sales and customer management, production and manufacturing, asset and plant management, inventory management, and procurement. Then, the business supplemented this functionality with non-SAP, industry-standard, quality, regulatory, and validation systems.

Because the preconfigured solution EzPharma is designed to support the biopharmaceutical industry, it worked out of the box with very little need for customization. “Clearly, the less customization you do, the happier you are,” says Kasok. “One of our drivers was minimal customization. We succeeded in keeping it very standard, which helped drive our timeline and will serve us well in the future.”

The Benefits of Visibility and Transparency

The SAP Business All-in-One implementation has already created a number of positive results for Gallus. The business is evolving and has doubled its development labs, added a large clinical suite, and is in the process of introducing additional commercial suites for clients. Through a virtual ownership model, trademarked as SuiteSPACE™, customers can now have their own dedicated manufacturing suite within the Gallus facility. (Refer to the “What Is SuiteSPACE™?” sidebar for more information.)

“Our objective is to make our facility feel like our customer’s own facility — with lower cost, equal or better flexibility, and a top-notch quality and regulatory framework,” says Kasok. “With the SAP Business All-in-One solution, we can offer our customers visibility and transparency. We can create portals to share customer data directly with them and can isolate this data to ensure that customers only have access to their information. Having that ability built into the software is very important.”

This kind of data transparency and access enables customers to download information when they want to, schedule daily uploads, and even stream live data to view the performance of their process. It has enabled information sharing so customers can see the status of materials, quality of batches, and more. According to Kasok, this provides the level of openness and collaboration that Gallus strives for.

“A common complaint of working with a contract manufacturer is the feeling of losing control and losing touch with your process,” says Bamforth. “There’s a fear of not finding out about a problem until it’s grown into something that affects your supply. Now, through our approach, enabled by the use of technology and the transparency it brings, those clients are in touch with their process and have much greater security over their supply.”


Future Plans

Gallus is actively looking at how the business might partner or acquire additional technologies and capacities to network and connect across different sites. “What we’re doing to expand, in terms of adding functionality, is client-focused and driven by what our customers need with regard to their ability to access data and view the performance of their process,” says Bamforth.

As the business continues to grow, it is key that the system grows and moves with it. “I want to have solid core systems and not need to worry about them,” says Kasok. “Our new solutions clearly achieve that, and we’re just at the tip of the iceberg of using these systems to their full advantage.”   

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