Albemarle Fine Chemistry Services

CDMO

Domestic Sourcing

Investment

Q2 2020

Quality by Design (QbD)

Strategic Partnership

Supply Chain

<h3>The pharmaceutical industry is experiencing significant changes, and many drug companies are looking to re-establish domestic supply chains utilizing U.S.-based CDMOs. Albemarle Fine Chemistry Services (FCS) has a domestic footprint, an impeccable regulatory record, and a successful history of collaboration, and is continuously enhancing its robust development and manufacturing capabilities.</h3>
<h4 style="font-weight: normal">Operating in a New World</h4>
The pharmaceutical industry has been experiencing a heightened level of change for the last decade. Quality issues at many lower-cost suppliers have led to drug shortages and concerns about supply chain security, an issue further underscored by the evolving COVID-19 pandemic. Cost pressures have also mounted as governments, insurers, and patients seek to address rising healthcare costs.

<h4 style="font-weight: normal">Understanding Crucial Customer Requirements</h4>
Outsourcing partners must provide highly efficient, secure, and cost-effective solutions that facilitate speed to market. They must have the ability to thoroughly characterize and control raw materials, processes, and products. A quality-by-design (QbD) approach, top-notch quality systems, and foundational quality culture are all imperative, as is the ability to support projects from lab-scale to large-scale commercial production as they advance through the clinic. 
Albemarle FCS places great emphasis on establishing close relationships with our customers. Building on relationships established early on allows us to gain a deeper understanding of the specific projects and our customers’ longer-term needs.
 In addition, as a U.S.-based company with a proven track record of scaling up for foreign and domestic clients, Albemarle FCS provides the highest standards of quality while maintaining a transparent, direct partnership between our team and our customers to ensure optimal collaboration. Physical proximity makes communication at every stage of a program simpler. Our excellent safety, environmental, and quality records at both sites (South Haven, Michigan, and Tyrone, Pennsylvania) provide assurance to customers that their projects will meet the highest standards and not be delayed by problems with regulatory agencies.
<h4 style="font-weight: normal">Investing to Meet Changing Customer Needs</h4>
Another benefit of partnering with Albemarle FCS is the flexibility we offer customers in terms of the types and scales of projects we can address and our willingness to invest in technologies and capabilities to ensure success. We pay close attention to the evolving concerns of our existing or potential customers when evaluating potential investment opportunities and are always ready to invest in capabilities and resources that will enable us to meet key market needs.&nbsp;
We also strategically invest in projects designed to enhance our overall performance. These investments not only improve our capabilities but also our safety and quality performance, further building on our long track record of robust and reliable service to the pharma industry.
<h4 style="font-weight: normal">Enhancing RSM Capabilities and Security of Supply with an Integrated Offering&nbsp;</h4>
We have successfully back-integrated key regulatory starting materials (RSMs) for internal use at our South Haven cGMP facility. This integration increases supply chain security and provides an unparalleled level of transparency into starting materials. This gives us the ability to identify and control impurities earlier in the API manufacturing process and to collaborate to implement potential process optimizations that will impact the quality of the API. The teams at South Haven and Tyrone collaborate to identify opportunities for improvement, set production schedules, and address logistical issues. Albemarle’s customers benefit from this integration, particularly as it relates to identifying impurities, method development, process development, scale-up, regulatory compliance, and speed to market.&nbsp;
Albemarle FCS also provides this service to external pharmaceutical customers. The industry has expressed a need for a reliable supply of high-quality U.S.-produced RSMs, and our Tyrone site is equipped to meet those needs. We recently invested in capabilities to enhance our ability to meet the growing demand for smaller-volume pharmaceutical intermediates and to produce RSMs.
A new, state-of-the-art operations building features a consolidated control room, QC laboratory, and offices for production coordinators and lab analysts, creating a collaborative office area. By moving the QC lab out of the shared R&amp;D space, we were able to upgrade and expand the capabilities of the QC lab while also increasing the capacity of the R&amp;D lab, creating further opportunities to upgrade the overall infrastructure, equipment, and capabilities as required to meet our customers’ needs.
The QC lab, now 60% larger, provides a more effective working environment. There is ample space for the integration of existing equipment, including inductively coupled plasma mass spectrometry (ICP-MS) for elemental metal impurity analysis, and for the expansion of analytical capabilities to support the rapidly growing RSM business.&nbsp;
<h4>Facilitating Collaboration</h4>
Collaboration is a core Albemarle value and an essential consideration when new designs are evaluated. We carefully considered the interactions between the operators and the QC lab. The building was designed to enable the safe delivery of process samples, given the chemical hazards that might be present, from the production area to the QC lab. In addition, the flow through the lab was designed to allow operators in the control room to interact directly with QC technicians. The close proximity of the control room and QC lab and the inclusion of collaborative workspaces significantly increased the level of interactions and productivity between the two groups.
The implementation of a new laboratory information management system (LIMS) accessible to both laboratory and production personnel has also facilitated more effective interactions between the two groups. Operators are able to work with QC technicians and chemists to print sample labels and can access real-time data from their workstations. The team that writes procedures is collaborating more efficiently with operators and QC personnel, leading to the more efficient development of practical procedures. The results are positive — we have realized both intended and unintended benefits from the design, which led to even stronger support for our clients and accelerated time to market.
The collaborative relationship between the Tyrone site and the South Haven GMP plant is also tremendously beneficial, allowing us to enhance our management of change and other systems that align with cGMP requirements for an RSM supplier.
<h4 style="font-weight: normal">Major Equipment Investment at South Haven</h4>
Investments have also been made at the South Haven site. The installation of a Hastelloy conical dryer, which is scheduled to be completed by mid-2020, will enable us to meet the growing demand for existing products, expand solid product production capacity, and increase our ability to accept projects involving challenging materials. The new Hastelloy dryer has expanded capabilities to handle the processing of acidic and more corrosive materials. In addition, this new unit will be in a suite that allows drying, handling, and packaging of Category 3 materials.
<h4 style="font-weight: normal">Leveraging Existing Strengths</h4>
Whether it is through the reconfiguration of equipment layouts, the new construction of more efficient buildings, or the installation of new technologies and systems, we strive to facilitate collaboration and increase efficiency across the site. With these and other strategic investments to come, we will continue to ensure the ongoing provision of innovative, state-of-the-art solutions to our customers as their needs evolve.
At Albemarle FCS, we are continually gauging the current and future needs of our customers — particularly in terms of efficiency, cost-effectiveness, and security of supply — to direct our own investments to expand our capabilities and capacity. As such, we are well-positioned to support our pharma customers today and in the future and sufficiently flexible to adapt our operations or make further investments should those needs continue to evolve.

Positioning a CDMO to Meet Future Needs