What Makes a Great Liquid Oral Dose CDMO?

Key Takeaways

• Selecting a liquids and semisolids CDMO requires evaluating more than manufacturing capacity; specialized expertise in formulations, technology transfer, process scale-up, quality, filling, packaging, and regulatory compliance is essential.

• Liquid solutions, suspensions, creams, gels and ointments present distinct manufacturing challenges, including maintaining suspension uniformity, controlling emulsion formation, and reproducing critical mixing and homogenization conditions at commercial scale.

• TriRx’s Huntsville, Alabama, facility supports liquid and semisolid pharmaceutical manufacturing in batch sizes ranging from 30 to 5,000 gallons, including complex formulations to support human and veterinary products including Schedule II–V controlled substances.

• Integrated manufacturing, tube and bottle filling, packaging, and serialization capabilities can reduce timelines for technology transfers, limit operational handoffs, and support more reliable commercial supply.

• Experienced cross-functional teams, consistent quality standards, realistic project evaluation, and transparent communication help CDMOs identify risks early and build durable customer partnerships.

A truly effective pharmaceutical contract development and manufacturing organization (CDMO) must be more than a source of capacity. Whether supporting drug substance production, drug product manufacturing, or both, the right partner should combine reliable execution with technical depth, regulatory discipline, and the ability to communicate openly when a project becomes more complex than expected. Strong CDMOs function as strategic partners, bringing together skilled and experienced staff, advanced equipment and facilities, and well-established systems for quality, compliance, technology transfer, process scale-up, and on-site process and analytical method development.

Those attributes matter because customers are not simply buying batches; they are entrusting a CDMO with product quality, supply continuity, regulatory expectations, and ultimately patient access. A strong partner must be able to manufacture high-quality products on time and in full at a fair price, while also maintaining an excellent compliance record and respecting the needs of employees, suppliers, and customers. Just as importantly, the organization must be honest about what it can do, what it should not do, and what it will take to complete a project successfully. That is where trust is built: by doing what has been promised, communicating clearly when challenges arise, and making decisions that protect the product, the customer, and the facility.

In essence, a successful CDMO must have, in the words of TriRx Founder Tim Tyson,¹ “world-class facilities, with world-class capability, with world-class people that understand on-time delivery and regulatory compliance.” Trust comes next, and it is earned by consistently applying those strengths in the service of customer success.

For CDMOs that support specialized products, these expectations become even more demanding. Liquid oral products and semisolid oral and topical products require specific expertise, technologies, and operating discipline to ensure that processes are robust, scalable, and optimized for the product’s intended use. The challenges can vary significantly across solutions, suspensions, creams, ointments, medicated shampoos, human therapeutics, and animal health products. Only a limited number of CDMOs can provide comprehensive support across that full range of product types, applications, and batch volumes, from smaller development or commercial needs through high-volume manufacturing.

The Huntsville, Alabama, facility became the foundation of TriRx Pharmaceutical Services in 2019, when the company purchased the liquid and semisolid manufacturing plant after it had been shut down by Par Pharmaceuticals, an Endo International company. Originally established by Qualitest Pharmaceuticals in 1996 and later acquired by Par, the site had a long record of producing liquid and semisolid products on a scale. It also offered a combination that is difficult to replicate: purpose-built infrastructure, specialized equipment, established regulatory systems, and an experienced workforce with deep knowledge of the products, processes, and facility.

Those strengths made the Huntsville site an ideal starting point for TriRx. The facility already met the core criteria for a strong CDMO: world-class capabilities, a history of reliable performance, recognition as a high-quality supplier, and a highly skilled team eager to return to the work of making important medicines for patients and consumers. TriRx reemployed more than 150 former employees from the Par site, bringing back people with direct experience in engineering, technology, operations, quality, supply chain, and production. That continuity mattered. Rather than building expertise from scratch, TriRx was able to restart the site with many of the people who understood its systems, equipment, and manufacturing nuances best.

Today, the U.S. FDA-approved Huntsville facility includes more than 197,000 square feet of manufacturing, packaging, development, and warehousing space. It supports small- to large-scale contract pharmaceutical manufacturing, with batch sizes ranging from 30 gallons to 5,000 gallons, for prescription and over-the-counter human and veterinary liquids, creams, gels and ointments. The site also has capabilities for Schedule II–V controlled substances, supported by a strong track record with the Drug Enforcement Administration. An in-house development testing laboratory further supports manufacturing and transfer activities, allowing TriRx to serve a broad customer base that includes emerging, established, and large pharmaceutical and animal health companies.

That breadth is increasingly important in a market where customers may need high-volume commercial production, smaller batch manufacturing, or both. Huntsville was built for flow and scale, but TriRx has continued to adapt the site to support a more diversified mix of customer needs across liquid and semisolid dosage forms.

Liquid and semisolid products are sometimes treated as mature dosage forms, but that should not be mistaken for simplicity. The technical requirements can vary substantially from one product type to another, and each format brings its own manufacturing, scale-up, and filling considerations.

Liquid oral products may be solutions, in which the drug substance is dissolved in the liquid, or suspensions, in which solid drug particles are distributed throughout the liquid vehicle. Suspensions are especially demanding at large scale because the process must keep the active ingredient uniformly suspended from manufacturing through filling and throughout storage. Many manufacturers are reluctant to produce suspensions at volumes above 100 gallons because of the technical difficulty involved. TriRx routinely produces even complex suspensions in batch sizes up to 2,000 gallons, supported by the equipment, process understanding, and operating experience needed to maintain uniformity at scale.

Creams and ointments introduce a different set of challenges. These semisolid products often rely on oil-in-water or water-in-oil emulsions formed under tightly controlled conditions, including temperature, processing time, vessel configuration, and mixing dynamics. In many cases, production occurs in jacketed reactors under highly specific mixing and homogenization conditions. The thickening and homogenization step is often a critical point in the process: if the emulsion does not form properly, the batch may not be recoverable. Developing and transferring these processes therefore requires a detailed understanding of how the formulation behaves, how the phases come together, and how small changes in conditions can affect product quality and stability.

Manufacturing is only part of the challenge. Liquids are generally filled into bottles, while semisolids are filled into dispensing tubes, and those downstream differences require distinct equipment, controls, and operator expertise. A process that produces a stable liquid or semisolid product must also be paired with a filling and packaging strategy that can preserve quality, control fill weight, minimize waste, and support commercial supply.

The TriRx site has been manufacturing liquid and semisolid therapeutics for over 30 years. The Huntsville site is set up with the right equipment and an experienced team that understands how to make these products correctly from formulation through filling and packaging. In addition to large-scale suspension manufacturing, TriRx fills creams, gels and ointments in 5-g to 100-g plastic, laminate, and metal tubes, giving customers support across a broad range of product formats, batch sizes, and commercial needs.

Technology transfer into a CDMO site is rarely a simple matter of reproducing an existing process exactly as written. Even when a formulation, manufacturing process, or analytical method is well established, differences in equipment, procedures, utilities, raw material handling, and site-specific systems can create variables that must be understood and addressed before routine production begins. Whether the transfer involves a raw material method, a finished product method, or a manufacturing process on the production floor, each step must be carefully vetted to account for the nuances of the receiving facility.

Scale-up adds another layer of complexity. A process that performs well at bench scale does not automatically translate to commercial production, particularly for liquids and semisolids. Larger batch volumes can introduce differences in vessel geometry, heat transfer, mixing dynamics, homogenization, order of addition, and the ability to demonstrate uniformity throughout the processing tank. Critical process parameters that appear straightforward at small scale may behave differently once the process is moved into larger equipment, and those differences must be evaluated before they create problems in validation or commercial supply.

The transfer process must be scientifically justified, fully documented, and controlled through the site’s quality system, including appropriate change control, risk assessment, process and analytical method transfer, equipment and facility evaluation, validation or qualification activities, and regulatory impact assessment. This is where experience becomes essential. Successful tech transfer and process scale-up depend on process engineers, technical services teams, quality experts, and operators who know where hidden risks can emerge and which questions need to be asked early. TriRx’s team has seen many different transfer and scale-up scenarios and can apply that experience to identify potential issues before they become production challenges. When a process description does not fully account for how a charge, mixing step, homogenization step, or filling requirement will behave at scale, the team works with the customer to clarify the details, evaluate the options, and establish an optimized approach before moving forward.

For liquid and semisolid products, that upfront discipline can make the difference between a smooth transfer and a costly delay. By combining site-specific equipment knowledge with decades of manufacturing experience, TriRx is able to help customers translate processes into practical, scalable, and controlled manufacturing operations.

Modern CDMOs must be flexible enough to support customers as their needs change across development and commercialization. A product may begin with smaller development or launch-scale requirements and then move into larger commercial batches as demand grows. Other products may require small-volume production for specialized markets or high-volume manufacturing for broad supply. CDMOs that can support final drug product manufacturing, filling, packaging, and related development activities within the same site can help customers reduce complexity, avoid unnecessary handoffs, and limit the time and cost associated with additional technology transfers.

TriRx’s Huntsville facility was purpose-built to support liquid and semisolid manufacturing and packaging across a wide range of scales. The site has equipment trains for both liquids and semisolids, allowing products to move from smaller batches to larger commercial volumes while maintaining comparable processing principles. For example, the equipment is designed so that similar mixing dynamics, including vortex formation, can be achieved in both smaller and larger tanks. That consistency is important for liquid and semisolid products, where mixing, uniformity, heat transfer, and processing conditions can directly affect product quality.

The facility also includes the infrastructure needed to support reliable pharmaceutical production at scale, including a robust water system for producing USP purified water. For customers, these capabilities mean that TriRx can evaluate how a process behaves in the Huntsville environment, identify any adjustments needed for scale-up, and then support manufacturing and packaging without requiring the product to move among multiple external providers.

Packaging and serialization are also important differentiators. Before TriRx acquired the site, a fully automated high-speed packaging line had already been installed, and the facility was prepared for serialization requirements well ahead of the regulatory deadline. The site moved early to unit-level aggregation, giving the team deep practical experience with serialization systems, vision inspection, labeling, cartoning, boxing, and pallet-level controls. As a result, TriRx brings not only the equipment required for liquid and semisolid packaging but also the operational knowledge needed to manage serialization efficiently as part of routine commercial supply.

Filling creams and ointments into tubes presents a very different set of technical challenges than filling solutions or suspensions into bottles. Semisolid products must be filled accurately despite differences in viscosity, flow behavior, tube format, and product characteristics. The filling process must also preserve product quality while maintaining tight control over fill weight, labeling, serialization, and downstream packaging.

TriRx supports semisolid filling with an automated IWK filling line designed to operate within tight process parameters. Inline check weighing allows the system to identify filling issues in real time and automatically divert affected units from the process flow. Those units can then be inspected and, when appropriate, returned to the line or reworked if they fall outside specification. After filling, the tubes move through an integrated packaging process that includes tube embossing with lot and expiry information, cartoning, insert placement, and barcode application. A human-readable 2D barcode is applied to each carton and verified by an automated vision system to confirm accurate aggregation. The cartons then move into boxes, and the boxes are placed on pallets. The entire semisolid line can be operated by a small team, reflecting the high level of automation and control built into the system.

TriRx also has extensive liquid and suspension packaging capabilities, including seven packaging lines. The newest is a high-speed, fully integrated PSA filling line with a 30-head volumetric filler. The system fills based on product flow, using Coriolis-based measurement and the ability to adapt to the behavior of each product. Once the system understands how a product fills, it can maintain very tight control throughout the run, reducing filling errors, off-specification units, and costly waste.

That liquid filling line can process up to 200 bottles per minute and is automated from primary filling through labeling, cartoning, boxing, palletizing, and serialization. It can support batches of up to 40,000 units, equivalent to a 5,000-gallon batch filled into 16-ounce bottles. Together, these semisolid and liquid packaging capabilities allow TriRx to support a broad range of product formats while maintaining the accuracy, traceability, and efficiency required for commercial pharmaceutical supply.

Some pharmaceutical companies are cautious about working with CDMOs that manufacture both human and veterinary products. The concern is understandable: human and animal health products are regulated by different agencies, and each category may carry distinct submission, documentation, and market-specific requirements. At the operational level, however, many of the core expectations are the same. Cleaning must be validated, processes must be controlled, procedures must be followed, and the facility must be able to demonstrate that the appropriate controls are in place.

TriRx addresses those concerns by applying one high standard across the Huntsville site. Human health and animal health products are managed according to GMP expectations for human therapeutics, with each project treated as though it must withstand rigorous inspection, submission review, stability expectations, and customer audit scrutiny. This approach provides a cleaner and more consistent operating model than maintaining separate quality cultures for different product categories.

That philosophy is supported by practical controls throughout the facility. Specific lines are dedicated for different types of products, spatial segregation and signage help reinforce controlled flows, and procedures are designed to ensure that work is completed in accordance with applicable regulatory requirements. The site has also successfully supported products for multiple markets, including the United States, Canada, and Brazil, reflecting the ability to meet demanding regulatory and customer expectations across both human and animal health.

For customers, the result is a facility that can support a broader range of products without lowering expectations for quality, compliance, or control. Whether the product is intended for people or animals, TriRx applies the same disciplined approach to manufacturing, validation, documentation, and release.

Transparency is central to how TriRx works with employees, customers, and vendors. That expectation begins with our executive leadership and extends across the teams at the Huntsville site. For us, transparency means being clear about what the site can support, what timeline is realistic, what risks need to be addressed, and what decisions are needed to protect product quality and supply continuity.

That approach starts before a project is accepted. TriRx does not commit to work, volumes, or delivery schedules unless we are confident the site can execute with the right level of quality, compliance, and performance. Fit matters. A project must make sense for the facility, the customer, the product, and the people responsible for manufacturing it. That discipline can sometimes require difficult conversations early in the relationship, but those conversations are far better than discovering later that an assumption about timing, materials, equipment, or process behavior was wrong.

The same principle applies once a project is underway. Manufacturing is complex, and even well-planned programs can face challenges related to supply chain disruptions, long-lead components, process performance, or changing customer needs. When issues arise, TriRx brings them to the customer quickly and works collaboratively to identify the best available solution. The goal is not to avoid hard conversations but to have them early enough and clearly enough that both teams can respond effectively.

That straightforward approach has helped TriRx build strong customer trust. Customers value a CDMO that is honest about constraints, proactive about risks, and committed to solving problems rather than making promises it cannot keep. It reflects a simple operating philosophy: do what we say, say what we do, and make decisions that support the long-term success of the customer, the product, and the Huntsville site.

The trust TriRx has built with customers is inseparable from the quality, experience, and commitment of the people at the Huntsville site. Many team members have spent decades working with liquid and semisolid products, and many returned to the facility when TriRx restarted operations. That continuity gives the site a depth of practical knowledge that cannot be replaced by equipment alone. Chemists, engineers, operators, quality professionals, supply chain specialists, technical services experts, and site leaders work closely together, bringing a shared understanding of the facility, the products, and the expectations of pharmaceutical manufacturing.

That team-driven model is especially important in a CDMO environment, where priorities can shift quickly and customers may need support across transfers, scale-up, validation, packaging, supply planning, and commercial production. TriRx employees have shown the flexibility and adaptability needed to keep projects moving while maintaining the discipline required for quality and compliance. Their experience allows the site to identify potential issues early, communicate clearly across functions, and respond with practical solutions when challenges arise.

TriRx also works to maintain open communication internally. Site leadership holds quarterly town halls to share information about the market, the company’s position, and the priorities ahead, while also gathering feedback and suggestions from the people closest to the work. The company has also adopted flex schedules and other accommodations where appropriate, recognizing that workforce expectations continue to evolve and that retaining skilled people requires listening, adapting, and supporting employees in ways that make sense for both the team and the business.

For customers, that culture matters. The same people who understand the equipment, processes, quality systems, and supply constraints are the people responsible for delivering each project. Their commitment is one of the core reasons customers continue to place their trust in TriRx.

Transparency is one part of TriRx’s broader commitment to customer success. The Huntsville site also relies on structured, cross-functional decision-making to keep projects aligned with customer expectations, site capabilities, and regulatory requirements. The customer relationship team includes representatives from technical services, quality, procurement, commercial, operations, and site leadership. This group meets twice each week to review active projects, evaluate incoming opportunities, address risks, and ensure that customer programs remain on track.

That same discipline applies when TriRx evaluates potential new projects. A pricing committee meets regularly to review opportunities and determine whether they are the right fit for the company and the Huntsville site. Financial considerations are part of that discussion, but they are not the only factor. Safety, quality, cleaning requirements, product characteristics, facility fit, procurement needs, operational capacity, and the ability to execute reliably all must be considered before the site commits to a program. That process helps ensure that TriRx accepts projects it can support responsibly and successfully.

The value of that cross-functional model became clear soon after TriRx was founded. When the COVID-19 pandemic emerged less than a year after the company started operations, the Huntsville facility rapidly adapted to support hand sanitizer production. The effort required converting part of the facility and associated production tanks for explosion-proof operation. TriRx moved from concept to implementation in approximately 90 days and produced 12 million bottles over the following six months. Although the circumstances were unusual, the response demonstrated the site’s ability to align engineering, operations, quality, supply chain, and leadership around an urgent manufacturing need.

Looking ahead, TriRx is preparing for the next phase of growth at Huntsville. Discussions are underway regarding investments in facility infrastructure and additional advanced technologies that would expand the site’s ability to manufacture liquid and semisolid therapeutics efficiently, cost-effectively, and at the right scale for customer needs. The goal is to support a broader range of traditional and novel products, from simple to complex formulations and from small-volume programs to high-volume commercial supply, for both human and animal health markets.

TriRx already occupies a strong position in the liquid and semisolid CDMO space because of its specialized capabilities, experienced team, and purpose-built Huntsville facility. Continued investment will build on that foundation and help ensure that the site remains ready to support customers as they bring important medications to patients, consumers, and animals.

1. Covitt, Adam. “Restarting a Manufacturing Campus and Revitalizing a Community.” Pharma’s Almanac. 30 Sep. 2020.