You have opted to drop the sub brands of Pharma, Supply Solutions and Biosciences and are rebranding as SAFC. What is the rationale behind this decision?
We found that our customers wanted to interact with one SAFC. Although our brand segments helped us to build awareness in the different markets we are active in, they were also somewhat confusing to our audience. We wanted to build clarity around our business model under a single umbrella.
In light of the changing landscape, how have pharma/biopharma companies’ changing strategies affected your business?
Another trend we are witnessing from major pharma is a move towards ‘preferred vendor’ strategies to consolidate outsourcing requirements from a single supplier. As such, we have built up SAFC’s image as a solution provider for early-stage drug discovery through to bulk API manufacture, where clients and partners come to us with an issue and we then work alongside them to determine the best course of action. We then help to implement it from the ground up.
As an industry, contract manufacturers need to move away from the old ways of doing business and improve the entire value chain, rather than just a few convenient elements. This means being proactive in anticipating client needs before they arise. At our company, for instance, we anticipated that there would be increased interest from clients for high potency API (HPAPI) manufacture. We invested in this area so that these capabilities were already online when the demand arose, rather than waiting until clients requested these facilities.
What investments has SAFC made in HPAPI manufacturing technology and facilities?
In 2010, we added a second HPAPI facility in Wisconsin (USA) to complement our kilo and pilot labs already in place. This second facility has two large commercial trains, as well as an additional pilot plant, and enabled us to increase our manufacturing capacity by 24000 L.
While our facilities in Wisconsin are capable of supporting complex small molecules, we also recognised that there are some high potent compounds that are manufactured either completely through fermentation or in a semi-synthetic fashion. In 2010, we opened our new cGMP fermentation facility in Israel, which has a number of reactors (up to a 4000 L scale) and further expands our HPAPI offering.
Finally, a number of these high potency products are conjugated to other biologic products, such as monoclonal antibodies and these antibody drug conjugates (ADCs) complete our high potent franchise. Collectively, these capabilities give us an extensive capability toolbox to support diverse needs in the field of HPAPIs.
Do the absence of guidelines for the safe handling and control of HPAPIs present significant obstacles for suppliers of HPAPI equipment and the pharma/biopharma industry?
It doesn’t necessarily present obstacles so much as potential for confusion due to the different classifications. The industry has effectively created its own standards and there are several companies who can help provide guidance in this area. Because the application and use of equipment can vary, it is imperative that companies handling HPAPIs define requirements and specifications when designing and purchasing equipment.
In the absence of guidelines, we will continue to categorise each compound before it enters our facilities as a part of our safety and quality systems.
What are your predictions for the demands for HPAPI services in the near future?
A quarter of all drug candidates — from early phase to late phase — are in oncology. This is a main focus area for HPAPIs and is driving the need to identify new highly potent molecules that may be beneficial in the treatment of cancer. Of course, oncology isn’t the only use for these types of compounds, but it is a major constituent.
Some HPAPIs are used as a final API, but there has been much interest in combining these compounds with other therapeutics. Antibody drug conjugates, for instance, offer the potential for targeting through antibodies, enabling dissociation only inside the targeted cell.
How have you adapted to rising pressures to compete with less costly service providers?
While there is enormous pressure on cost, there is greater pressure in terms of quality and risk mitigation throughout the supply chain, including in the components that constitute an API. Regulatory bodies are demanding increased GMP compliance and there is also increased pressure from consumers, triggered by various industry scandals over the past few years.
Interestingly, at SAFC, we have witnessed an increasing number of late phase projects returning to the West, where the previous supplier had been located in the emerging markets. The reasons behind this shift can be attributed to quality, reliability and communication. Although cost remains important to our customers, it is more apt to focus on ‘total cost’, which factors in the cost of potential “non-quality” products.
As with any market, we must remain competitive so we’ve been working to optimise our cost structure through process improvements.