As part of its business strategy and ongoing commitment to being the best solution provider of choice to its pharma and biopharma customers, SAFC began the process of upgrading the Broadway facility, located in St. Louis, Missouri, in 2010. The goal was simply to create a facility with Animal Component Free and Animal Component Containing manufacture that would provide an expansion of capacity and an increase in regulatory and validation competency. What transpired was a complete overhaul of process and procedure that included a consolidation of product offerings from five different facilities.
We sat down with Jim Whitehead (Manager of QA) and Tim Zebas (Manager of Product Engineering) who were part of the original team that initiated the project, as well as Anthony Whitmarsh (Supply Chain Manager), David Bucklin (Production Manager), and Mark Jones (Plant Manager) who each joined at various stages throughout the redevelopment, to talk about their experiences. Collectively, their task was to deliver a world-class facility that supports SAFC’s drive to be the best manufacturing solutions provider to its customers in the pharma and biopharma market.
SAFC Live: Thank you for joining us today. The Broadway facility is fully online and fully functioning having gone through a substantial upgrade in the last 18 months. Tell us about the build out; including what the facility was previously used for.
Jim: The Broadway facility has been operating since the 1980s, manufacturing powder and liquid products such as media, sub culture media, buffers and serums in a non-segregated ACC/ACF environment.
Tim: During the discovery phase, prior to the build, it was confirmed that the Broadway location would be targeted as an SAFC “Center of Excellence”; in other words, Broadway would become a world-class facility. To start that process, we closed the facility in August 2010, and came back online in January 2011. During the project we also worked to transfer to an SAP system, create product harmonization, and get everything online with speed and efficiency. Some of the larger items included segregating ACC/ACF manufacturing, bringing in new equipment and water for injection (WFI) with ACC and ACF areas having their own segregated supplies, building larger capacity for storage and increasing the level of process validation for all products manufactured at Broadway.
SAFC Live: Can you give us more information about the product lines?
Mark: Broadway now produces (mainly) liquid media in segregated facilities that include fully validated manufacturing lines, environmentally controlled rooms, and increased throughput capacity. In total, we transferred in 280 custom products. In the beginning, the product offering was predominantly catalog items, but now we have a much larger custom business built out. I believe about 80 percent of our work is custom at this point. To put the facility update into perspective, we have transitioned from an original throughput of around 250,000 liters per year quickly ramping up to 850,000 liters in 2011. We are on track to achieve 1.1 million liters in 2012.
Anthony: Our original dry powder manufacturing was moved to the Lenexa, Kansas facility, so the only powder we work with here is for repackaging from bulk to smaller sizes and volumes. In order to roll out the Center of Excellence format, our strategy centered on the liquids capabilities and making upgrades to, or even fully replacing, what previously existed. Product lines from five different facilities were consolidated into three facilities, with Broadway receiving many of the products. We harmonized the resulting product line by only sourcing validated suppliers and using cutting edge testing technology, making our transfers seamless.
SAFC Live: What special features have been built into these offerings?
David: One of the biggest features we now offer is the level of customization in products and packaging. Our packaging offering is extremely flexible. We can deliver products from 10 mils to 1,000 liters in custom bags with different types of connections or bag/bottle combinations. We also have a high-speed fill line, which allows us to fill five bottles simultaneously and in less time than we could previously fill two. We identified contamination as a concern so we removed a lot of the human intervention previously required. The processes and product lines that we have adopted at this facility are replicated from our Irvine, Scotland facility, as much as possible to ensure product continuity. This is a key factor in keeping our supply chain uninterrupted, allowing us to manage environmental considerations.
SAFC Live: What did SAFC do to make the build out happen and ramp up the Broadway facility so quickly and how will it continue to move forward?
Mark: Once Broadway reopened, we shifted our focus to optimization and flow of materials. This is where we put a lot of time and effort in the first two quarters of 2012. Right now we are continuing to look at new technologies and have put time into product engineering for a more disposable manufacturing strategy.
SAFC Live: How does the disposable manufacturing strategy benefit the customer?
Tim: Simply put — consistency of product. From the customer perspective, disposables eliminate the chance of cross contamination by guaranteeing a cleaner and more consistent environment for the process.
SAFC Live: What response have you had from your customer base?
Jim: The response to the Center of Excellence business strategy has been very positive. In 2010, we had about four customer audits at the site. In 2011 and so far in 2012, that increased to 40, and in all cases they were very complimentary about the customization and segregation that the facility offers. Broadway operates under best practice standards, and even the FDA commented positively on the process when they were here recently
SAFC Live: Perhaps the most important question of all is how this affects the market?
Anthony: Broadway is on schedule to become a world-class facility. We are already catering to a wide range of needs in product manufacturing and packaging. The market has clearly spoken, and it wants quality and accountability for the end user. So, as we unite with our suppliers and customers to serve the patient market, we know that our offering has to be in line with and even exceed their expectations. We have a clear plan in place to be able to achieve that at Broadway. The build out at the Broadway facility allows us to offer a harmonized product line and guaranteed product continuity, which gives the customer the peace of mind in knowing that we have taken care of them so they can take care of their customers.
SAFC Live: Thank you all for your time.
For more information on the Centers of Excellence, read the original release here.
To learn more about SAFC’s liquid media offering, please click here.