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?
Bio/pharma companies are continuing to reduce costs and there is increasing pressure for their respective supply chains to
comply. As a consequence, we have seen more outsourcing of manufacturing and minimised investment in fixed costs, such as
plant costs. Pharma is also looking for greater supply chain flexibility, and is seeking to reduce working capital while still
being able to respond to demand fluctuation, so outsourcing is becoming more and more relevant. Of course, quality levels
at outsourcing companies need to be at the same level that a pharma company would have at their captive facility. Currently,
many plants can also only manufacture a limited number of products, but both the pharma and biopharma industries are demanding
contract manufacturing partners who have the ability and resources to switch between a diverse range of products every few
Gilles Cottier. President of SAFC.
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.