Alcami is a U.S. contract development and manufacturing organization (CDMO), offering integrated services in laboratory testing, drug product manufacturing, and cGMP pharmaceutical storage and support.
Bill, you told us last year about the three pillars behind your work at Alcami: drug manufacturing, laboratory services, and pharma storage. Could you tell us more about your expansion in the storage space over the previous months?
Our decision to expand our storage capability strategically with the acquisition of Pacific Pharmaceutical Services in Reno, Nevada earlier this year enabled us to reach clients we would not have otherwise. Many of these clients are smaller, earlier-stage companies on the West Coast, which helps us broaden our geographical presence and cross-sell services they might need down the line, such as laboratory services and manufacturing support. We also opened a new, state-of-the-art pharma storage facility in central North Carolina close to the Research Triangle Park. When added to our existing network, these two expansions created an extensive high-quality, secure cGMP storage network that maps to major biopharma hubs.
Pharmaceutical storage is long-term, secure specialty storage that includes validated cold chain monitoring and controls, and we offer a full range of conditions, from controlled and ambient temperatures to cryo or ultra-cold, plus the services to keep equipment and systems up and running, such as calibration and validation. Offering this end-to-end support helps set us apart, as we can serve clients across the spectrum of drug development. The pandemic also shifted the landscape by increasing focus on supply chain stability and storage needs. For us, storage is strategically vital because our network of locations enables us to support life sciences companies while tying into our other business areas.
In addition to pharma storage, we are fortunate to also be enjoying client growth in our other two core business pillars. Since the emergence of the BIOSECURE Act, we have seen an uptick in demand for our comprehensive laboratory services that include extensive analytical testing, formulation and method development and expertise and FDA guidance around popular areas such as extractables and leachables and nitrosamines. And in drug product manufacturing, all six sterile fill-finish lines will soon be up and running and we continue to experience high demand for production of complex medicines, especially following the acquisition of Catalent by Novo Holdings. At the same time, we are also anticipating a resurgence in oral solid dose manufacturing (pills and capsules) and related packaging services.
Having in mind that expansion, how are you handling the question of integration of these new assets?
Integration is essential, especially in acquisitions. For the Reno Pacific Pharma Services (PPS) acquisition, we focused on retaining the core team and the unique qualities that made PPS successful, while also aligning them with Alcami’s best-in-class policies. Quality is a hallmark of Alcami, which builds client trust and reliability, so we have adjusted their SOPs to harmonize operations across sites. This ensures that clients have a consistent experience across all of our locations.
We achieved this by putting experts on the ground and engaging with PPS staff as partners in the process. Explaining the 'why' behind each change fosters understanding and increases buy-in. Our goal is to create a uniform client experience, so whether a product is stored in Massachusetts, RTP, or Reno, clients can expect the same high standards. By sharing this vision with the team, integration becomes smoother, and clients benefit from a streamlined, consistent service across our ecosystem.
Do life sciences companies trust CDMOs for biologics and gene therapies?
Yes. The data supports strong collaboration between CDMOs and life sciences companies, particularly in large molecules. A recent CPHI Worldwide report indicated that around 50% of biologics, cell and gene therapies, and other large molecules are outsourced to CDMOs. This shows a growing comfort level within the industry, as life sciences companies increasingly trust us with complex molecules and advanced delivery mechanisms.
Quality remains the foundation of this trust. Our actions align with our commitment to quality, which resonates across the industry. This partnership enables life sciences companies to allocate resources to R&D while we handle the production side, helping to accelerate timelines.
Although some companies still prefer in-house control, CDMOs like Alcami offer a compelling value proposition by ensuring that high-quality medications reach patients efficiently.
What are the factors that have driven more companies to approach Alcami recently?
Organically, I think our commercial efforts to educate potential clients on Alcami’s capabilities, track record of success and our client-first approach has had a direct impact on attracting new business in 2024. I am very proud and impressed by our client-facing employees; namely sales, marketing, project management and technical evaluation, as they build strong and lasting relationships with our clients. You couple this with operations teams that pride themselves on quality work and crisp turnaround times and it creates a very attractive offering for existing and new clients.
Inorganically, I think there are two factors that have driven recent inquiries. First, Novo Nordisk’s acquisition of Catalent’s sterile fill-finish facilities has prompted clients to seek new options, leading them to us. Second, the US BIOSECURE Act has impacted Chinese-owned contract biomanufacturing organizations, motivating more companies to consider domestic, onshore options. Additionally, as life sciences increasingly shift toward large molecules, there is a higher demand for efficient delivery methods, like injections, which can sometimes offer long-term or even short-term cures.
We had previously talked about the difficult financing climate in life sciences. Has this changed one year later?
In my opinion, funding has improved, though companies remain cautious, focusing on cash conservation and prioritizing assets. Previously, with sufficient funding, companies might advance multiple molecules at once. Now, they are more strategic, carefully managing their cash runway to ensure they reach key milestones. The urgency persists, but it is directed toward prioritized molecules to optimize resource use.
This cautious approach resembles waves on a beach—companies now stagger their developments rather than pursuing everything simultaneously. By prioritizing, they are better positioned to see projects through to completion, enhancing the likelihood of success.
What do you envision for Alcami in the next year?
Growth is the word that defines our trajectory. With three additional sterile fill-finish lines coming online in RTP and Charleston, our capacity and capabilities will continue to expand, supporting our core pillars of manufacturing, labs, and storage. These pillars work synergistically, driving our growth alongside our deepening client relationships.
This year, we added 168 new clients, which reflects our effective business development and marketing efforts. The industry’s perception of Alcami has evolved beyond a legacy small-molecule lab company to include our expanded large molecule, sterile fill-finish, and storage capabilities.
Events like CPHI Worldwide showcased this shift, as we were super busy engaging with clients each day in valuable, strategic conversations, further evidence of our growth and transformation.
