During my MBA course, Professor Pierre Casse — then at the International Institute for Management Development (IMD) in Lausanne, Switzerland — regularly reminded us that one key to success was constantly finding new ways to “delight and inspire your clients†by creating value. SAFC achieved that objective in its “Overcoming Supply Chain Vulnerability and Lowering Risk in Biopharmaceutical Manufacturing†symposium 17–18th June 2014 in Turnberry, Scotland. Along with a day of industry insight, the event included a visit and tour of SAFC’s new dry-powder media manufacturing facility in Irvine, Scotland. With executive teams from several leading biomanufacturers in attendance, the event was blessed with surprisingly fine weather. We gathered and networked while admiring panoramic views across the Scottish Hebrides.
The symposium focused on supply chain concerns such as how to prevent drug shortages and capacity challenges; quality and variability in raw material supply; risk mitigation strategies; integrating biotherapeutic supply chains; meeting future requirements by defining comparability attributes; and ensuring the viral safety of raw materials.
Our Conversation
I spoke with Gilles Cottier (president of SAFC) about the Irvine facility. He shared some thoughts on hot issues and offered his view on key future industry needs.
Monge: Congratulations on the inauguration of your new dry-powder media facility. Can you briefly describe the key drivers for it?
Cottier: We have a facility that has been manufacturing dry- powder media for many years in the United States, but that site was operating at full capacity, so we needed to make a decision where to invest. We could have made another facility investment in Lenexa, KS, where our existing dry-powder media facility is located. But because risk mitigation is always a core focus for SAFC, we decided that it was better to build in another location.
Irvine, Scotland was ideal because we already have a facility for liquid media here, and we have the people and systems to support it. It is a good location from which to support our customers in Europe, ensuring shorter lead times, good customer service, and supply chain security. This facility doubles our existing capacity and mirrors the Lenexa facility using the same quality systems and same raw materials globally. The quality and supply chain programs are totally aligned.
We continue to build our expertise in the SAFC raw- material characterization program. Our analytical and cell culture scientists provide the scientific rationale for intelligent raw material specifications. This facility is designed with flexibility in mind: We use intermediate bulk containers for blending, with preblenders being totally mobile. Accelerated development schedules have proven to be a critical component of success for our customers. So as we build on our experience, we are constantly aiming to improve upon and shorten lead times. We achieve that through specialized manufacturing activities to decouple packaging and improve mill cycle times.
Monge: Tell us about this symposium’s title.
Cottier: We recognize the importance of thorough materials characterization so that our clients can understand the critical material attribute of each substance. This is important to help them understand and evaluate the potential impact of even very small material specification changes and prevent problems during manufacturing. SAFC invests a lot in ensuring highly reliable manufacturing, quality, and supply chain systems — and communicates openly with our clients on that. A 2013 report by the International Society for Pharmaceutical Engineering (ISPE) revealed that “material issues†account for ~20% of drug shortages, second only to drug-quality issues.
We aim to develop materials that are truly interchangeable between sites so that attributes such as trace elements, leachable substances, and other impurities do not vary. Complex and undefined raw materials are a well-known source for potential variability within biomanufacturing processes, so we also have a trace element initiative. Recent trends show rising concern over trace-element impurity profiles of composite media formulations because of the effect such impurities can have on glycosylation patterns and protein quality. Our initiative studies those impurities, which often come from starting materials or manufacturing processes.
Monge: What is your company’s key value proposition?
Cottier: Our value proposition is to reduce risk and total cost of ownership for our clients. That’s why we are investing heavily in our service offering.
We believe that to be successful, we need to make our customers successful. SAFC cannot be everything to everybody, so we are selective in the customers we work with to dedicate a significant amount of resources that best meet their current and future needs. We are also selective and highly targeted in the markets we aim to support.
Reducing total cost of ownership for our clients does not necessarily mean that we will be cheaper. SAFC believes in creating value for customers, and we will continue to invest in and refine our offerings to meet their needs. For instance, BioReliance’s testing services complement our core manufacturing operations because the teams work together to create virus resistant cell lines that help prevent contamination in bioreactors. We work to leverage our expertise in a way that reduces risk and total cost of ownership for customers. Clearly the viral safety of raw materials is a top priority. We know that viral risk can slow manufacturing and ultimately limit the availability of medicines to patients.
Monge: What do you see as your biggest challenge moving forward? What about the debate over delivering more affordable drugs to more than just the 30% richest of the world population?
Cottier: Costs need to decrease so that more patients have access to drugs. Only about 2 billion people currently have access to modern medicine out of a world population of 7 billion. In countries such as India, China, and Brazil the cost will come down, but the volume will go up for some drugs with billions of patients to treat. We expect that as the volume requirements increase, there will be economies of scale.
What can we do as a supplier — bearing in mind that we represent only a small portion of the final price that patients pay? I believe that consumers are willing to pay more if they can be cured. It is all about value, and there is a fair price for that. It is not the price per kilogram of our media that will really make the difference.
Our clients here today would be willing to pay more for media if they can have almost 100% assurance that our product won’t cause a drop in bioreactor performance. They want assurance that there will be no viral contamination. Customers want to see data that is not “fluff.†If we can provide value to our customers, then they can provide value to their customers (patients).
Monge: SAFC has a massive product portfolio: from custom cell line engineering to bulk liquid handling, preformulation, and extensive services in the antibody–drug conjugate field. Is there a missing link that you would like to add to that portfolio?
Cottier: We listen to our customers’ specific needs and are always refining our offerings with their input. Quality and security of the supply chain are very important. For a number of products that we continue to offer, instead of buying from other suppliers, we make them ourselves (wherever possible) to have a more integrated supply chain. For example, we launched the PharmaGrade initiative three years ago to provide high-grade, documented, off-the-shelf products that customers need. That portfolio taps into our broad chemical knowledge as SAFC along with intelligence from our Sigma-Aldrich side.
At time of writing, BPI editorial advisor Miriam Monge was a principal consultant at Biopharm Services. Since then she has become director of marketing integrated solutions for Sartorius Stedim biotech in Göttingen, Germany; miriam.monge@sartorius.com.