A complete set of capabilities across the entire drug continuum
Since 2014, AMRI has significantly expanded its service and product range through several acquisitions. Today, it has more than 3,100 employees at 27 locations in the US, UK, Europe and Asia, and it continues to seek new opportunities in areas of complex science. William S Marth, President and Chief Executive Officer, AMRI (Albany Molecular Research Inc), highlights key innovations.
What would you say have been the most significant developments in the industry for contract manufacturing and development to the pharmaceutical market over the past 21 years?
The most significant for CDMOs is the increase in companies choosing to outsource discovery, development and manufacturing. There are many factors driving this increase, which include reducing overhead costs, gaining access to specialised technologies and improving quality and efficiency. There has also been an increase in outsourcing, due to the complexity of new biologic entities.1
How has your company evolved to meet customers’ challenges?
Our service offerings and problem-solving capabilities have always evolved to meet our customers’ needs. We are following where our customers’ pipelines are headed. We believe our ability to offer a reliable and efficient integrated service model, which also allows customers to use a combination of our US, European and Asiabased facilities. will result in an increase in demand for our global services.
Most recently, we strengthened our portfolio of services and products through acquisition and organic growth initiatives. For example, we acquired Euticals, a multi-national provider of both APIs and William S Marth, President and Chief Executive Officer, AMRI (Albany Molecular Research Inc) development services, expanding both our sterile manufacturing capacity and our footprint in Western Europe.
Within our DDS business, we established an integrated discovery center in Buffalo, NY, to address customers’ increased demand for discovery services. We also provide services for customers that have projects in other phases of development. For example, we have added key analytical and testing services, such as solid-state chemistry, extractables/leachables and impurities, in vitro bioequivalence testing and container closure integrity testing.
In our Drug Product business, our strategic focus is on products with high barrier to entry challenges. More than half of the pharmaceutical industry’s pipeline is made up of products that will need sterile drug product services. We have four facilities that can do everything from pre-formulation and formulation, through process engineering to full-scale commercial manufacture.
Looking ahead to the next few years, what do you think will be the main opportunities and challenges affecting your industry?
The ability to provide an integrated offering that can take compounds from early research, through development to commercial manufacturing, is something that customers look for in service providers. Challenges ahead will be the constant need to invest in technology, equipment and expertise in increasingly specialised areas of service.
Moving forward, AMRI understands that our customers are looking for unparalleled delivery and service levels across a full range of complex products and solutions as they look for new suppliers, or look to consolidate their existing suppliers. We expect to see what we see in other industries, which is industry consolidation, leaving larger and fewer buyers and fewer providers of those services and products.2 It is our aim to be a reliable and responsive partner through the entire lifecycle of our customers’ products and meet the demands of customers’ increasingly complex supply chains.
How is your company preparing for these developments?
As our customers continue to seek innovative new strategies for R&D efficiency and productivity, we continue to align our business and resources to address their needs. Our organisational structure, combined with a continued focus on excellence and quality, should enable us to continue to drive long-term growth and profitability.
What are your customers’ key requirements from their CMO or CDMO, and how are these changing, if at all?
There has been a shift in recent years in the relationship between pharma companies and CMOs/CDMOs.2 Relationships are viewed more as strategic partnerships and less as straightforward operational outsourcing. Technical expertise, a heightened focus on quality, a robust supply chain function, access to innovation, and risk management will be key drivers in outsourcing.2 How can customers get the most out of their CMO or CDMO? When choosing a CMO/CDMO, three characteristics to look for in a partner are communication, expertise and trust. Customers should set expectations around communications and secure the CMO/CDMO’s commitment to that. Many collaborations are unsuccessful because people are not communicating in a way that meets each company’s needs.
The CMO/CDMO should never over promise. What you should look for is a partner that explains how they will work with you to overcome the challenges when they inevitably arise, and how they will communicate if they believe that your project may not be feasible. CMO/CDMOs should be empowered to think about your project independently, critically and analytically. With communication and expertise, trust will follow between the CMO/CDMO and the customer.
What would you say has been your company’s outstanding achievement (or achievements) of recent years, and what impact had this had on your customers and potentially the industry more generally?
Not only have we expanded our reach into new geographic markets, we have enhanced our services and capabilities through strategic organic and inorganic growth initiatives that have spanned all of our businesses. We offer customers a complete set of capabilities across the entire drug continuum.
1. Changes in the Wind for the CDMO Market Pharma’s Almanac TV: Nice Insight Research. March 8, 2017. www.pharmasalmanac.com/articles/changes-in-thewind- for-the-cdmo-market.
2. CMO Roundtable: What’s Next for the Contract Manufacturing Industry. Pharmaceutical Processing. March 21, 2017. www.pharmpro.com/ article/2017/03/cmo-roundtable-whats-nextcontract- manufacturing-industry.
AMRI focuses on three key businesses: Discovery, Development and Analytical Services (DDS); Drug Product; and API. It provides comprehensive and customised solutions that span early discovery and development through scale-up to commercial manufacturing. It has more than 250 commercial products in its portfolio, which includes products in its API and Drug Product businesses. In the area of API manufacturing, AMRI supports the chemical development and cGMP manufacture of complex APIs, including potent and cytotoxic compounds, sterile APIs, steroids and controlled substances. Its facilities provide the capability to support the manufacturing of both small-scale development and large-scale commercial batches.