June 11, 2019 PAO-06-2019-CL-001
Albemarle Fine Chemistry Services (FCS) is a business unit within Albemarle Corporation — a large company with approximately $3 billion in revenues and more than 5000 employees — that provides contract development and manufacturing services to the pharmaceutical industry and other specialty chemical sectors.
With two production sites, Albemarle FCS operates with the mindset of a small company. FCS is a tight-knit community within the company, and there is open, direct communication between all levels of the organization. Our president and senior management are highly interactive with the production sites, with direct and open engagement with all team members, not only about their jobs and where they would like to see improvements, but also about their personal lives and well-being.
The compact structure and collaborative communication allow FCS to be highly flexible and nimble, aligning our activities closely with those of our pharma partners. As such, we behave like a small company — but with access to the funding and resources of a large, global corporation.
Constant open communication leads to tremendous cohesiveness within FCS. Each customer project is supported throughout the life of the program by a cross-functional team that includes the program manager and representatives from R&D, quality, analytical, engineering and all other relevant departments. The members of these close-knit teams are in constant communication with one another. They also understand what each participant’s role is and how they can support each other.
Customers are encouraged to include their technical experts in our project teams. We rely on our customers to share their product and process knowledge with our team so that we can move all projects forward through the development cycle as quickly as possible. This approach further fosters transparent communication and collaboration, which are essential to success for both Albemarle FCS and our partners.
Transparency is just one of the values that drive the culture of both Albemarle collectively and FCS. Care, Collaboration and Integrity also underlie our quality performance. These values inform and guide what we do, how we communicate and how we work through process scale-up issues. Incorporation of these fundamental attributes within our project teams guarantees that they operate smoothly.
The members of our project teams understand that the processes they are developing will impact patients, including members of their own communities. At Albemarle, we recognize that establishing a clear and open line of communication among our teams and our customers is essential to prepare for and address challenges, without disrupting the timeline or failing to achieve our collective goals. We work diligently to establish an environment in which everyone’s opinion is respected, and all voices are welcome. This type of collaborative environment, where all perspectives are heard and considered, facilitates the development of optimal solutions.
Curiosity is another prerequisite for success. Our scientists at FCS demonstrate endless curiosity and seek to gain the greatest possible depth of understanding about our partner programs. At the same time, they recognize the importance of meeting customer expectations with respect to cost and timelines. The result is the performance of phase-appropriate research and development work designed to support the needs of each specific project and customer.
In some cases, customers are interested in gaining greater process understanding early on and are therefore willing to invest additional time at the beginning of a project. In other cases, timelines are short; in these instances, our R&D teams will often perform experiments during scale-up that do not add to the project timeline but provide additional process understanding and crucial information that may be useful when moving to commercial production.
For all projects, scale-up efforts are focused on ensuring long-term success at commercial scale. At our South Haven, Michigan site, we can perform runs at the lab (up to 100 L), pilot plant (up to 500 gallon) and commercial (up to 4000 gallon) scales. Throughout the process development and optimization stages, eventual commercial production is kept in mind as a key objective. Processes are designed for practical implementation under GMP conditions, and potential issues that might arise as a project progresses are anticipated and addressed.
The culture of trust that exists at FCS is highly valued by all employees. The company continually fosters a supportive environment and is constantly working to preserve this culture across both manufacturing sites. Underlying this effort is the recognition that we are all working to improve and extend the lives of patients. Having that objective in mind helps to clear out any barriers and encourages understanding and trust between and within groups.
The culture at Albemarle FCS also drives our commitment to safety and quality, which are our top priorities and as such are ingrained into everyday activities. We recognize that establishing and meeting high safety and quality standards are essential to our success. Quality and safety are constant talking points and are woven into every aspect of our operations. They are designed into processes from the outset. Our quality and safety groups have a large presence on the plant floor, and operators are trained to preserve quality on an ongoing basis and identify any potential risk points. Management is also proactively involved in developing and discussing safety and quality initiatives and identifying areas for improvement.
Establishing strong lines of communication can also establish new efficiencies in safety and quality assurance throughout the supply chain. One such efficiency at FCS results from our ability to supply regulatory starting materials (RSMs) from our Tyrone, Pennsylvania facility to our cGMP API production facility in South Haven, Michigan. Collaboration between teams at South Haven and Tyrone builds process and product knowledge, including an enhanced understanding of impurity profiles for our raw materials. Additionally, before implementing process changes/improvements at Tyrone, we are able to provide insight on any potential risks and impacts associated with those changes and suggest characterization studies (or other lab work) that should be performed before making the change. As a result, we have a unique level of control over the properties of raw materials that are important to our customers’ processes, a capability that is becoming more critical as regulatory bodies are demanding tighter control over RSMs.
The foundation of Albemarle’s culture is honesty, integrity and transparency. At FCS, we have no hidden agendas. We openly discuss difficult issues that many other CDMOs may prefer to avoid. We bring our pharma partners into the discussion early, even when we are tackling difficult questions. Albemarle’s success is defined by our customers’ success, and the goal is to achieve the best possible outcome, through a collaborative culture within the company and with our partners.
Julie Risdon has been with Albemarle since July 2008 and currently leads the custom pharma business within the Albemarle Fine Chemistry Services division. She has over 17 years of experience in pharmaceutical and custom manufacturing, including increasing leadership positions at Pfizer. Julie received her B.S. in chemical engineering from Ohio University.