Creative cultures

SAFC (Sigma-Aldrich Fine Chemicals) supplies the biopharmaceutical industry with essential raw materials for cell culture applications. Joseph Altham spoke to Edward Roullard, SAFC’s vice-president of marketing and supply chain, to find out how SAFC’s products help the biopharmaceutical industry to develop new pharmaceuticals and vaccines.

SAFC is a specialist unit within the leading life science and high technology company, Sigma-Aldrich. Sigma-Aldrich’s core business focuses on research, where smaller quantities of a vast array of materials, delivered very quickly sets it apart as a market leader. SAFC, in contrast, focuses on customers moving into development and ultimately commercial manufacturing. “SAFC was developed as a different business unit because the customer requirements beyond research evolve to have different emphasis,” said Mr Roullard. “We serve several different markets, but the largest is the pharmaceutical industry.

SAFC works across the pharmaceutical industry supplying contract manufacturing capabilities, raw materials for use in chemical synthesis processes and final formulation, and key components used in biopharmaceutical production. The development and commercialisation of new treatments and vaccines is a long-term process. SAFC works in close partnership with pharmaceutical corporations to help them bring new therapeutics, pharmaceuticals and vaccines to market. “While we provide some off-the-shelf solutions, much of what we do is custom-manufactured for our customers. The biopharmaceutical industry is particularly strong for us; their evolving needs and our strengths, particularly in powder media and liquid media, make us strong partners.

SAFC’s headquarters is in the American city of St Louis, but it has manufacturing facilities in Switzerland, Germany and the UK, as well as in several cities in North America. There is also a special division within SAFC, SAFC Hitech, which works with the electronics industry on improving the capabilities of semiconductors. In 2010, SAFC as a whole had annual sales of $643 million.

Why biopharma?

Mr Roullard offered an outline of the way the biopharmaceutical industry is transforming medicine. The pharmaceutical industry has traditionally relied on chemistry for the development of new drugs and produced thousands of therapeutics over the past 50 plus years. While chemistry approaches to produce “small molecules” continues to be a highly viable approach to preventing and curing disease, “large molecule” (protein) technology has evolved over the past 20 years, and is now the fastest growing segment of the pharmaceutical industry. “One approach is not better than the other, but therapeutic proteins as an approachs means that the pharmaceutical industry has a new way to address disease such as cancer or rheumatoid arthritis. As evidence, virtually all of the largest pharmaceutical companies now employ both approaches.

Biopharmaceutical drug and vaccine production is less absolute and predictable than traditional chemistry routes. The manufacturing process includes growth and feeding of mammalian cells to produce the protein product. While much is known about making this process successful and repeatable, living systems are not absolute.

Edward Roullard, vice-president of marketing and supply chain

So, once a successful approach has been establish, minimizing changes is critical - pharmaceutical companies need the stability that comes from working with a reliable partner. “To support a pharmaceutical company, you have to come in at the clinical trial phase, and have the quality systems to ensure that change is minimised, and at best fully characterised,” said Mr Roullard. “If the customer then succeeds in getting the product to market, it is really not in their interest to change suppliers.” How does the process work?

Mammalian cells produce proteins as part of their everyday function in our bodies. Biopharmaceutical processes utilise a bank of cells that have been modified to produce a target therapeutic protein or vaccine. In a biopharmaceutical process, cells are put into a “bath” in which they growth over a period of 1–2 weeks, and produce proteins in the process.

SAFC provides the bath to customers either as dry powder or liquid. “It would be the (complex) equivalent of a consumer buying kool-aid in either dry or liquid form. And the factors for a pharmaceutical company are oftentimes, the same as a consumer. How much space do I have, what are the economics, do I have the ability to hydrate my powder?”

There is a significant trend towards using disposable reactors rather than stainless steel reactors for cultivation of cells. The drivers of this trend are reduction in capital expenditure, reduction in required space,

Rathburn Chemicals Ltd

Rathburn Chemicals Ltd is an independent company based in Scotland. Specialising in the purification of solvents for Laboratory use and other exacting applications, we were the first company to offer solvents for HPLC. As well as producing for our own brand, we are accomplished in manufacturing to customers precise specifications, particularly where these exceed the norm. We purify all materials offered, in glass, at our own factory and therefore have full control over quality.

Rathburn Chemicals Ltd have been suppliers to SigmaAldrich for many years and we look forward to an excellent ongoing relationship.

Rathburn Chemicals is a leading supplier of high purity solvents for Chromatography and Residue Analysis.

In a business where quality and absolute reliability are essential, Rathburn Chemicals has built a customer base across Europe supplying prestige organisations such as Sigma-Aldrich, leading Pharmaceutical companies, universities and research institutes. We specialise in purification of solvents to customers specifications.

Rathburn Chemicals Ltd. Caberston Road, Walkerburn, Peeblesshire, Scotland, EH43 6AU Tel: +44 (0)1896 870 329/65 | Fax: +44 (0)1896 870 633 E-mail: exports@rathburn.co.uk

flexibility, and reduction in changeover costs. “Disposable reactors are essentially big plastic bags. We ship liquid media to our customers in bags which they can immediately utilize as their reactor.”

In Scotland, SAFC recently invested $8m in its Irvine site, establishing a Centre of Excellence for the production of liquid media and reagents. “This investment reflects SAFC’s growth and gives the Scottish facility more capacity for serving the liquid media market,” said Mr Roullard.

In addition to media, SAFC provides the feeds necessary to keep cells alive, buffers to maintain pH, and the processing aids necessary to both manage the production process and isolate and purify the desired protein after it has been produced.

Results

SAFC leverages these capabilities in other industries and at further stages in the production process. In addition to human therapeutics, SAFC serves the animal health industry to produce, in particular vaccines. And it utilises facilities and Gillingham, UK and Arklow, Ireland to produce novel adjuvants (compound which increase the immune response to a vaccine); it was a key supplier of adjuvants to the vaccine industry during the swine flu epidemic.

SAFC’s success across all of the industries it serves is built by having a deep understanding of customer needs, assembling the different capabilities described above to meet those needs, and removing the complexities that its customers face. n