Global biopharmaceutical manufacturers demand a high level of quality, service and consistency when it comes to the supplies they need to produce their products. In order to meet these demands, suppliers must commit the resources, facilities and expertise to deliver whatever is needed, when it is needed, with a guarantee of quality assurance.
SAFC, a global company that supplies a multitude of services to the biopharm/pharmaceutical industry has recently opened a new Dry Powder Media (DPM ) manufacturing facility in Irvine, Scotland to complement their Lenexa, KS DPM facility. By doing so SAFC has shown their commitment to their customers and this growing segment of the pharmaceutical industry.
BACKGROUND AND MARKET DRIVERS
The Irvine, Scotland site was acquired by Sigma-Aldrich in 1993 and received its first update several years later when the company built what is now referred to as the Industrial Production Building or IPB One.
The next major milestone in the site’s history was in 2005. In 2005 Sigma Aldrich and JRH Biosciences mergers to form SAFC Biosciences. It was at that time that company management sat down and mapped out a plan for the company’s future.
According to Rod Kelley, SAFC’s Vice-President of Manufacturing, that meeting was the stepping off point for the company’s future. “We started SAFC Biosciences and we sat down with Archie Cullen (President of SAFC’s BioReliance Division) – and he led us through a review of the market, the competition and where we were, and said here is where our strategy should be – to be able to grow in this marketplace.”
From that meeting, the company decided that the market demanded two primary things.
First it was risk-averse – the market does not want to deal with a lot of risk, but risk can come in many different ways.
Costs were also a market driver – SAFC wanted to prove the value they could bring to the market and help their clients reduce their total cost of ownership.
From these two main findings, SAFC developed an operational footprint. This footprint would make sure the company could provide their main services to their customers. First, they wanted to provide business continuity to their customers. Second they wanted to improve the consistency of their products. As Kelley notes “It used to be about how much cells can I grow – how much product can I produce. Today, it’s not so much about how much – but about what bandwidth I have – every time I fill my fermenter what can I expect to come out of the bottom – because if I don’t know – production planning becomes a disaster – downstream processing becomes a disaster – so consistency and reproducibility were every important.”
Finally, SAFC identified flexibility as a goal for their operational footprint. “We wanted to make sure we had increased flexibility,” says Kelley, “because we wanted to serve the whole industry – and have supply efficiencies.”
A JOURNEY BEGINS
With everything that SAFC had learned about the market they embarked on a journey. In 2006 the company had assets in four different locations producing liquid media and three locations producing dry powder media. After a close examination of these facilities, SAFC realized that all the facilities were built at different times, and to some degree for different purposes and by different people who had different manufacturing philosophies.
When this capacity was put up against the question of whether this reduces risk for the customer – the simple answer was no according to Kelley. “So we embarked on a journey of improving our manufacturing footprint to where we are today.”
Kelley continues, “Today, we have three cell culture facilities that in our opinion provide true redundancy, risk mitigated operations and provide the opportunity to lower the cost to our customers or provide greater value to our customers – whichever way you want to describe it.”
A CLOSER LOOK AT THE LENEXA AND IRVINE FACILITIES
In 2010, SAFC added some capacity to the Lenexa, KS facility. As Kelley explains, “At that time we had a large scale operation and reduced the scale and increased the ability to have a wider range of batch sizes and we dedicated that facility to continue to support media that contained animal components.”
Also at that time, the company added some additional capacity for liquid media in Irvine. It was at this point in time that SAFC declared the Irvine facility to be a completely animal-free facility. “So when you look at our footprint,” says Kelley. ”If you need something with an animal component it will be produced in the US. All animal component free media, either liquid or powder, is produced in Irvine.”
These steps were the beginning in SAFC’s journey to make real the goals they had set in 2006 and 2007.
The final piece of the puzzle was the additions and upgrades at the Irvine, Scotland facility. As the company planned to bring additional products to the Irvine facility the first thing that had to be done was the expansion of their warehouse facilities
According to Kelley, the company accomplished two very important customer-focused objectives with the opening of the Irvine facility.
“Until we opened this facility we only had one DPM facility which is uncomfortable for our customers and we wanted to take that discomfort away,” says Kelley.
“But also if you look at it – we were trying to satisfy all of our global reach with one facility. By regionally locating our facilities it reduces our customer’s costs.”
“For the largest cell culture manufacturing locale – which is Europe – we will now start to satisfy primarily Europe from Irvine, we will support North America from Lenexa, and both sites will continue to support the Asia/Pacific region.”
He continues, “The second thing we wanted to focus on was to provide our customers with true redundancy. We did have redundant capacity. In 2006 we could make cell culture media in lots of places – but we couldn’t tell the customer that we manufactured the product exactly the same. Today we are really close to telling a customer that we are manufacturing a product exactly the same no matter where you get it.”
“They want to know that when they put that material into their bioreactor that it is going to work every time and it will come as close as a biological system can to be being the same every time.”
LENEXA AND IRVINE – COMPARED
Both facilities have very similar processes – but improvements gained from years of experience at the Lenexa facility have been incorporated into the Irvine facility. The objectives at the Irvine facility were to mitigate risk, lower costs, increase flexibility, and get to market first.
One of the first things SAFC did at the Irvine facility was to settle on pin milling technology. Pin mill technology allows the Irvine facility to produce a large amount of material very consistently.
“One of the beauties of using pin mill technology is that we use nitrogen to convey the material and it does multiple things for us,” says Kelley. “When you put material in a mill it increases the temperature – some material more than others – by conveying with nitrogen it provides cooling so that we can dial in the temperature we want to mill at and, in addition, it adds an additional level of safety to prevent dust explosions. We’ve reduced that risk.”
Quality control is also of upmost importance when supplying media to biopharmaceutical companies and all of SAFC’s facilities operate under a single quality control system.
In addition, in order to ensure quality from the very start of production, SAFC has a raw material program that begins in their Cell Sciences and Development (CSD) Group. It’s there that the company characterizes the higher risk raw materials. The CSD group identifies components and will determine not only if the material just meets the specifications, but what the impurity profile is of that raw material and how it might affect cell cultures.
Kelley elaborates on SAFC’s supply chain and their vendor program “Our supply chain begins early to identify the critical parameters of the high risk raw materials so we can find the right vendor to supply the material in that very tight range. Once we have identified the producers they go into our approved/qualified vendor program and that approved vendor supports all of our sites. This helps with consistency and reliability and reduces cost for our customers – it makes their life easy.”
“Our facilities are supported by a single supply chain.”
A CLOSER LOOK AT THE IRVINE FACILITY
While the Lenexa, KS facility served as the template that the Irvine, Scotland facility was based from, experience has led to changes and improvements reflected in the new location.
One of the most important differences between the two facilities is that at Irvine there are several empty rooms. This was done intentionally. Part of the cost of the new facility was to design additional space, so the company could respond quickly to increases in market demand.
This strategy not only benefits their formulation operations such as milling, filling and weighing but also their packaging capabilities, allowing the company to better serve the market.
Additionally, at the Irvine facility, SAFC changed some of the blending concepts to improve efficiencies and flexibility. They decoupled the packaging activities from the formulation line. Once material comes through the mill and it is put into an IBC- a portable blender and is moved out of the formulation area. Once the product is removed from this area the mill and blender can be cleaned and put back into use. The product in the IBC can then be staged or sent directly to the packaging area. This process give SAFC a much shorter cycle time on the mill.
Kelley elaborates, “One might argue that if it (the product) sits and waits for packaging we have increased the total cycle time on the process – but it allows us to better utilize milling and decrease our lead times and better serve our customers. In addition we have moved away from our small scale equipment such as our fixed stainless steel blenders and use portable IBCs to keep the process moving. This is a big advantage for customers on smaller scale projects with less quantity needed. Reaction time for customers is quicker.”
SAFC also uses the OSIsoft Pi Data Historian to capture critical data such as temperature and mill speeds.
“We review this data so that we can hone in on our process and make sure we are operating in the right parameters,” says Kelley. “And to look at nuances that need to be tweaked by the formulators.”
He continues, “We can also send specific manufacturing data to customers on their batches, this allows them to analyze the data and can help us tweak our process as well – Lenexa and Irvine are capable of this.”
“The more info we can provide the better it is for our customers.”
While the Irvine facility might be perceived as a newer and more advanced version of the Lenexa, KS facility, Kelley is quick to point out their missions remain the same.
“Lenexa and Irvine are very redundant. It doesn’t matter where the product is manufactured because it can be done with the same quality, with the same materials, exactly as the customer specified.”