According to Stephan, small and mid-size pharma and biologics companies are the innovation engines of the industry. “Each year, the number of new INDs and NDAs increases and we anticipate this trajectory to continue. We see more than 5000 clinical introductions on an annual basis. Cancer treatments are a particular area of focus for many of our clients and we expect our pipeline for these therapies to grow within the next 5 years. Our target accessible market is around $8 billion.”
KR: How does Alcami plan to grow with the industry?
SK: We have strategically invested in capability extensions and operational excellence initiatives to better meet industry demand. At our Germantown (Wisconsin, USA) Center of Excellence for API development, scale-up and commercialisation, we have supplemented our existing pipeline with HPAPI suites and controlled substance capabilities.
In Wilmington, North Carolina, we have added serialisation capabilities to our oral solid dose and parenteral drug product packaging lines. We have also installed a second manufacturing line for sterile drug product at our clinical and commercial parenteral manufacturing and lyophilisation facility in Charleston, South Carolina. In St Louis, Missouri, we’ve unveiled a new state-of-the-art Center of Excellence facility for advanced analytical testing, which significantly expands our laboratory capabilities.
Growing with the industry comes down to listening to our clients. We work with our customers to transform their ideas into a scalable drug product and then substantially accelerate its path to market. We’re also developing our team to advance client-centric initiatives and onboarding in-house emerging pharma and biologic trailblazers to take our clients’ projects to their next major milestones.
Additionally, we are opening commercial offices around the globe to be more integrated, available and accessible within the innovation communities. Our most recent office openings are in Tokyo, Japan, San Diego, California, and Cambridge, Massachusetts. Above all, client experience is our compass for measuring success.
KR: Can you tell me about any critical new offerings?
SK: Protect Your Brand is one of Alcami’s signature services that provides clients with a secondary supplier without the secondary commitment. Designed to support research and development for pharma-biotech companies pursuing a dual source strategy, the programme offers tech transfer and product validation in advance of potential manufacturing needs without any long-term commitment or minimum annual volume.
Protect Your Brand can be used for drug substances, drug products, clinical supplies, launch quantities and commercial supply. Alcami can be ready quickly to bridge unexpected gaps in your critical supply needs.
Alcami’s Extended Workbench is a Full-Time Equivalent (FTE) programme tailored to a client’s specific project. Dedicated Alcami employees focus solely on a client’s project to provide the flexibility, freedom and control they need for their outsourced laboratory requirements. An Extended Workbench programme can vary in size, management type and scope, as needed, and is available across all of our pharmaceutical platforms.
Alcami continues to set the industry standard with its analytical testing offering; and, through operational excellence, streamlined processes and technical knowledge and expertise, has reduced timelines by up to 30%. Our industry leading turnaround times in analytical testing give our customers the ability to manage urgent needs and adhere to strict manufacturing schedules.
Alcami can execute analytical testing for basic chemistry services in just 7 business days, from sample receipt to report or certificate of analysis release. The current industry turnaround is approximately 10 days. We can also perform basic microbiology analysis in 12 days, 3 days faster than the industry average.
Alcami OnDemand is a customer portal application that provides a superior customer experience in terms of ordering, project tracking and management. The easy-to-use platform allows you to submit samples to help meet your turnaround time needs, check project status and connect with your project manager.
KR: What has changed at Alcami in the past 3 years since the launch of your new brand?
SK: As I mentioned, we have continuously invested in capability extensions (HPAPI in API, controlled substance in API, serialisation in packaging, line 2 in sterile drug product) to serve the needs of our customers and operational excellence initiatives (new Center of Excellence site for advanced analytical testing) to create more flexible and responsive capacity. We have also launched the aforementioned critical new service offerings, Protect Your Brand, Extended Workbench, Industry Leading Analytical Testing Turnaround Time and Alcami OnDemand.
We have acquired more than 80 new manufacturing molecules, aided in the launch and approval of multiple products and secured 14 end-to-end programmes — proving the validity of our business model and market need for our custom-tailored services. Lastly, we have gained sponsorship from our new owner, Madison Dearborn Partners, who are enabling us to be the model platform CDMO in the industry. Alcami is well positioned for growth.
KR: With recent changes to regulations, how can pharmaceutical companies meet global consumer needs while meeting regulatory requirements?
SK: Pharma companies can simultaneously meet global consumer needs and quality/regulatory expectations by continuing to focus on and invest in their people, processes and systems.
KR: Tell us about some of the most interesting new technologies and services that Alcami has encountered recently. Have they made manufacturing easier or more difficult?
SK: The capability extensions and operational excellence initiatives I’ve mentioned in our growth strategy have streamlined manufacturing processes and allowed us to creatively control capacity.
KR: How do your customer needs vary across API, drug product and disciplines such as development services? Do you approach each of these customers differently?
SK: We offer solutions tailored to our customers’ individual needs, whether it’s one technology or across our entire suite of technologies. The best approach is to understand each customer’s needs and provide options that ensure they meet their short-, mid- and long-term goals.
KR: How are service suppliers such as Alcami advancing the science of pharmaceuticals? What is their role and how is the relationship managed?
SK: Today, CDMOs are the critical pieces in the puzzle that turn medical concepts into tomorrow’s medicines. We aid in the progression of innovation through the development of manufacturing routes, execution of new manufacturing strategies, by supporting regulatory pathways and the development and implementation of analytical solutions. Our dedicated project and programme managers are ensuring the timely execution of our clients’ projects while adapting immediately to the challenges in the clinic.
KR: How will Alcami continue to adapt to meet increasingly tough market and patient needs?
SK: We will continue to meet market needs by putting patients and customers first, and ensuring we always prioritising focus on safety, quality, science and technology. Customers are a privilege, not a right. Customer experience is key to our success. Every customer and project, large or small, should be treated as a VIP and deserves our utmost attention to detail.
NB: This article will appear in the March 2019 issue of Manufacturing Chemist. A recent digital edition is available online.