Ensuring Quality, Flexibility, and Capacity in Today’s Drug Development Landscape

Today’s drug products require advanced development and manufacturing capabilities and flexibility to ensure quality and capacity needed in today’s CDMO landscape. Supporting drug programs across all phases is also increasingly important.

Alcami, a US-based contract development and manufacturing organization headquartered in NC, has evolved significantly over the years, from its origins as an analytical lab services provider, to growing its capabilities in sterile fill/finish, oral solid dose, clinical and commercial manufacturing, and storage.

Timothy Compton, Chief Strategy Officer at Alcami, shares insight on streamlining timelines and reducing risk, and Alcami’s integrated model—from early development through commercial manufacturing.

Contract Pharma: Alcami has evolved significantly over the years. From a strategic perspective, how would you define Alcami’s value proposition today in the CDMO landscape?

Timothy Compton: The value proposition of Alcami remains quality, flexibility, and capacity.  We operate under one, industry proven, quality system here at Alcami that supports our stellar regulatory track record for some 45 plus years.  Every program has its unique needs, timelines and deliverables which require flexibility of the CDMO to pivot where the program needs are and that’s a key attribute here at Alcami. We continue to experience strong year-over-year growth from returning customers and new customers alike and to meet the capacity demands of our customers, we also continue to expand. There are current expansions underway in the areas of analytical labs in support of biologics, new clinical/commercial sterile fill/finish capacity within our FDA audited facility, and continued expansion of GMP pharma/biopharma storage.  The Value proposition of Alcami is the same across all services, whether it’s Pharma Storage, Drug Product manufacturing or Lab Services.

Contract Pharma: While Alcami is well known for its analytical lab services, which the company was founded on in 1979 as AAIPharma, today what are some of the lesser known but equally critical services you offer earlier in the late phase development and commercial supply?

Timothy Compton: Yes, Alcami is well known for our analytical lab services, but perhaps the lesser known services are Sterile Fill/Finish and Oral Solid Dose Clinical and Commercial Manufacturing, and Pharma Storage.  All services can be provided as a standalone service offering or bundled together to develop and deliver clinical and commercial drug product.

Contract Pharma: Can you tell us about Alcami’s analytical testing and characterization capabilities—and how they play a role in ensuring a smooth transition from development to manufacturing?

Timothy Compton: A key component of all successful manufacturing programs is a strong and robust analytical package of test methods to characterize and release drug substances and drug product. We have one of largest and most talented analytical networks in the U.S.  It’s also a critical factor in the timely onboarding of drug product programs, whether developing methods for the first time or transferring late phase methods. At Alcami we have the bandwidth and capacity to start the analytical development or transfer the day we receive materials without delay or long lead time for resources. We support programs of all phases, whether first-in-human or tech transfer for commercial manufacturing and large or small molecules, there is very little that we can’t support with our Analytical team. 

Contract Pharma: Stability storage and controlled storage environments are often overlooked but critical to success. How has Alcami built out its storage infrastructure to meet client needs?

Timothy Compton: Our Pharma/Bio Storage services is second to none here in the U.S. We operate more cold chain walk-in capacity than any other CDMO in the United States. One cold chain facility alone has walk-in storage (5C to -80C), yes -80C walk-in, equivalent to over 2,000 standard upright reach-in chambers. For business continuity, our walk-in chambers have triple redundant power/refrigerant back-up and multi-level security access with very tight tolerances. When it comes to stability storage, we offer multiple options and locations, from disaster recovery storage only to storage and testing (leveraging our analytical lab services). We currently have over 1,000 ongoing stability storage studies. We have immediate capacity to onboard storage to support the smallest or largest commercial needs.

Contract Pharma: Many biopharma clients are looking for integrated partners. How does Alcami’s integrated model—from early development through commercial manufacturing—help streamline timelines and reduce risk?

Timothy Compton: As mentioned earlier, we do operate under one quality system, that is the first and key step to being integrated across services. Leveraging all our services on a program allows for a number of opportunities to improve timelines. From storage and release testing of incoming materials (DS and components) at Alcami so materials are ready for manufacturing to packaging and labeling of drug product in parallel with the release of the batch. Keeping all the storage, testing, manufacturing, packaging and labeling under the control of one Project Manager and team has significant advantages. 

Contract Pharma: Innovation is key to remaining competitive. What are some recent investments or innovations Alcami has made in capabilities, technologies, facilities, or people?

Timothy Compton: We continue to make investments across our company and people alike. We’ve expanded our leadership within drug product manufacturing this year with a few key hires and promotions to support the investments we’ve made in sterile fill/finish manufacturing. Those investments include the addition of new liquid and lyo vial filling within isolators that are Annex 1 compliant. We are focused on creating redundancy and scalability across all areas of our business. To support these efforts, we recently implemented and released SAP S/4HANA as our new ERP system.

Contract Pharma: What trends are you seeing from clients in terms of demand for development services, and how is Alcami adapting to meet those expectations?

Timothy Compton: A large push for U.S. development and manufacturing. Some factors driving this are Tariffs and the resurgence of the Biosecure Act, which have changed behaviors in the marketplace. CDMOs like Alcami, which have recently expanded their domestic capacity and bandwidth to onboard programs swiftly, are well-positioned to continue experiencing growth in 2026 and beyond.

Contract Pharma: Regulatory expectations are increasing, especially in analytical testing and data integrity. How is Alcami supporting clients in meeting these requirements during development?

Timothy Compton: Alcami’s analytical lab services services has been at the forefront of meeting these requirements and expectations, being an early adaptor of 100% paperless ELN system and with the implementation of LIMS via Waters NuGenesis.

Contract Pharma: As biopharma pipelines become more diverse—from small molecules to biologics and niche modalities—how is Alcami adapting its strategy and services to support a broader range of products?

Timothy Compton: Alcami has supported biologics programs for 20+ years but agree the new modalities and recombinant proteins continue to be a large part of the industry’s pipelines. From a storage perspective, we have significantly increased our capacity to store GMP materials at the cold or ultra-cold conditions all the way down to -135 C (LN2 storage). As a US-based CDMO we offer the largest amount of cold chain storage. Beyond storage, we the capability to aliquot/sample and test these materials within our internal lab network. From a manufacturing perspective, our new filling lines are completely single-use, provide low-line-loss with non-destructive weight checks and container-closure-integrity testing (CCIT) as each vial filled is a vial that can treat a patient.  Our biologics customers often ask how small a batch we can produce versus how large and we offer scalability from single liter to 1,000-liter batches.

Contract Pharma: Looking ahead, what areas of Alcami’s business do you expect to see the most growth in over the next few years?

Timothy Compton: Continued growth in biologics (storage, analytical lab services and drug product manufacturing), but without sacrificing the support of small molecules which still make up the largest segment of our industry. It’s a great time to be at Alcami and our growth over the next few years will be equally exciting.