SAFC Commercial is the custom manufacturing and services business unit of Sigma-Aldrich Corporation. Its portfolio includes high-purity inorganic materials for high-technology applications, raw materials and biologics safety testing services for biopharmaceutical manufacturing, and complex, high-potent APIs and key intermediates for pharmaceutical manufacturing.

SAFC recently launched the EX-CELL Advanced product line. The company says the line addresses the needs of an evolving industry where speed to market is paramount and provides for increased performance, streamlines regulatory compliance, and offers the supply chain security needed in today’s biopharmaceutical environment. The first EX-CELL Advanced product is the high-performing batch media system developed for a range of widely used industrial CHO cell lines, including SAFC’s proprietary CHOZN cell line.

In other news, SAFC recently entered a commercial sales and service contract with biopharmaceutical company, BeiGene. Located in Beijing, the oncology company purchased SAFC’s off-the-shelf CHOZN cell line production platform and cell line engineering services to support discovery and commercial development of BeiGene’s targeted oncology drug.

Earlier in the year, SAFC validated its recently expanded facility in Irvine, Scotland, which now features dry powder cell culture media. The Irvine expansion, announced in March 2013, was initiated as part of a five-year capital investment plan designed to support SAFC customers with critical products and services across the globe. Now fully validated, the site acts as the European counterpart to the Lenexa, KS, Center of Excellence for cell culture media manufacture and supply in the U.S.

Recently, Gilles Cottier, Executive Vice President at Sigma Aldrich and President of SAFC, sat down with Contract Pharma to talk about the company’s areas of growth and where it plans to focus its efforts.                                                 —TW

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Contract Pharma: What are the growth prospects for the business?
Gilles Cottier: Without a doubt, it’s supporting our customers as they develop and manufacture biological drugs. But if you peel the onion, there are different layers there.

Obviously, monoclonal antibodies are the workhorse of the industry. But look at antibody-drug conjugates: they epitomize the perfect marriage of large molecule and small molecule. That’s a significant opportunity in the future.

Gene therapy is another area where we’ve been involved for a long time. It’s taken a while to develop, but in the past year there’s been a slew of interest coming from large pharma as well as funding for smaller biotech companies. If gene therapy continues to move forward, it marks a big opportunity for us. Not only do we perform testing, we also have the manufacturing capabilities. There aren’t too many companies that can do this.

CP: Are you looking to get into dosage form in any of these areas, like ADCs, where you have so much drug substance/conjugation expertise?
GC: We recognize that dosage form for ADCs is a different business and requires a different set of expertise. With gene therapy, we already perform fill and finish on the clinical scale. Our facility in Carlsbad, CA is in prime position to handle gene therapy products as they move along the regulatory pipeline. We can handle a significant number of vials, but we would need to scale up to a higher level with some products if they gain commercial approval.

CP: Do you see client relationships growing more strategic? Is it easier to develop a strategic relationship on the products side or the services end of the business?
GC: Our strategy is very clear. We don’t want to be everything to everybody. We are working with our top 100 customers.
On one side, you have the largest companies in the industry, and we have focused our efforts to work with them. Then there is another set, focused on specific, very targeted areas, like ADCs or gene therapy. Some of these smaller companies have novel technologies and we very much want to work with them, because we want to be the expert CMO in these fields.

Especially with larger customers, we have to make sure we can add value to what they’re pursuing, while capturing a portion of that value. All our efforts are about working in collaboration with our customers to develop game-changing solutions. I don’t believe it’s a one-way street; you can’t just impose your technology and solutions on the customer. We want to work with their supply chain to make a real difference.

This sort of strategic partnership takes various forms. We’re in different stages of this type of collaboration with several customers.
There are fewer than 20 that we’re working with like that. Collectively, these customers account for a significant portion of our revenue, and that portion has been growing at a double-digit rate. I don’t believe you can grow in this industry at that pace if you’re not creating value for those customers.

CP: What are the challenges for the business, going forward?
GC: There are always headwinds in the industry, whether it’s late-stage failure or drugs not turning out to be as successful as projected. That means that we have to think about our customers. At the end of the day, they serve their own customer, who is the patient.

The cost of medicine is significant, and there’s increasing pressure from the payer. So if you can develop a drug that is going to cure a disease for good, payers will be willing to pay for it. Some of these companies in the gene therapy area, they’re working on diseases that are incurable today, but they could make the difference between life and death for a child.

These companies are trying to develop treatments so that a patient takes one dose and they are cured. Some of these diseases don’t have many patients, so we must ask how they justify so much investment. The price tag for these treatments might be very high, but they cost less than the ongoing medical expenses that still wind up with a patient dying prematurely.

The challenge for the industry, and for us to help the industry, is to help make these treatments both affordable and available. It’s not enough to develop a new gene therapy that can cure what was once incurable. We also have to work to make sure those treatments aren’t only available in rich countries. The distribution logistics can be mind-boggling in developing countries, but it’s a key part of the equation.

The price for a dosage needs to come down, but that will increase the volume and reach of the drug.

CP: What do your customers need to do?
GC: I think that our customers need to streamline their supply chain; they manage thousands of suppliers, and those suppliers are sourcing projects from all over the world. We want to help reduce the risk they face, and create value for our customers, and that benefits the patient. That’s the challenge we face and the question we need to answer.