Authors: Justin Lacombe, Ph.D., Chief Scientific Officer, and Sheetal Muley, Ph.D., Senior Director Research Development, Experic
Large contract development and manufacturing organizations (CDMOs) promise end-to-end solutions, but their broad approach often lacks the deep expertise needed for complex drug development. Specialized CDMOs like Experic provide tailored support, combining advanced formulation and manufacturing capabilities with high-touch service. With expertise in inhaled and encapsulated drug products, high-potency compounds, and precision powder processing, Experic helps emerging and mid-sized biopharma companies mitigate development risks, streamline commercialization, and accelerate time to market.
The Shift Toward Specialized CDMOs
A major trend in pharmaceutical outsourcing has been the rise of large contract development and manufacturing organizations (CDMOs) positioning themselves as “one-stop shops” offering “end-to-end” services across the development cycle. In theory, consolidating drug development and manufacturing within a single provider should streamline processes, reduce costs, and accelerate timelines from early development through commercialization. However, this model often falls short in practice.
Large, full-service CDMOs frequently lack deep expertise in specialized technologies, instead offering a broad but generalized portfolio of capabilities. In drug development, “adequate” is not enough — each stage demands a high level of precision and scientific rigor to ensure the creation of safe, effective, and commercially viable drug products
Even when large CDMOs attempt to provide specialized support through designated “centers of excellence,” these offerings tend to be constrained by proprietary platform technologies, leaving little room for customization. Small and emerging biopharma companies, which often require tailored solutions and close collaboration, may struggle to receive the same level of attention as larger, high-value clients. Additionally, the promise of seamless end-to-end services is often undermined by fragmented operations. Many large CDMOs have expanded through acquisitions, leading to disconnected sites with differing quality systems and project management styles. As a result, technology transfers — intended to be minimized under the one-stop-shop model — are often still required, adding complexity and potential delays.
In contrast, smaller, specialized CDMOs can offer the expertise and agility that many pharma and biotech companies need. Their focused capabilities, coupled with flexible approaches to problem-solving, allow them to meet the unique demands of each client. Unlike larger providers, these CDMOs foster direct communication between leadership and subject matter experts, enabling faster decision-making and a more integrated development process. Additionally, many operate within strategic collaborative networks, allowing them to provide end-to-end solutions while maintaining a high level of specialization at each stage of the development cycle.
Two Dimensions of Flexibility in CDMO Partnerships
In pharmaceutical outsourcing, true flexibility is more than a buzzword — it is a critical factor in successfully advancing drug development programs. Flexibility can be categorized into two distinct but equally essential dimensions: macroscopic and microscopic.
Macroscopic flexibility refers to a CDMO’s ability to adapt at a strategic level. This includes investing in new equipment, modifying existing processes, expanding facilities, and integrating external expertise through collaborations with specialized partners. Many CDMOs hesitate to make these adjustments due to cost, regulatory complexities, or rigid operational structures. However, for customers working with innovative or highly specialized drug products, this level of adaptability can be a deciding factor in the success of a development program.
Microscopic flexibility operates at a more granular level, allowing CDMOs to respond swiftly to evolving customer needs. This means being agile in adjusting protocols as new data emerge, enabling real-time decision-making, and fostering seamless collaboration. It also includes accommodating customer site visits and expediting data generation to facilitate productive discussions. Unlike rigid, process-driven CDMOs, those with strong microscopic flexibility understand that unexpected challenges are inevitable in pharmaceutical development. Their ability to pivot quickly and refine processes in response to new insights can significantly reduce development risk and accelerate timelines to the clinic and market.
By prioritizing both macroscopic and microscopic flexibility, CDMOs can offer not just services, but true partnership — helping their clients navigate the complexities of drug development with agility, efficiency, and confidence.
Experic: A Specialized CDMO with a Personal Touch
Experic has deliberately positioned itself as a specialized CDMO, offering a unique combination of expertise in drug formulation, manufacturing, and device development. Our capabilities extend beyond standard CDMO services, incorporating advanced production technologies, such as Harro Höfliger’s equipment for inhaled drugs and encapsulation and specialized systems for handling highly potent active pharmaceutical ingredients (APIs). This focus allows us to seamlessly transition customers from lab-scale development to pilot-scale clinical trial production and, ultimately, to high-volume phase III and commercial manufacturing — without requiring fundamental process changes.
Our high-touch, customized approach is particularly valuable for small and emerging biopharmaceutical companies that lack extensive internal resources and rely on strategic outsourcing partnerships. Unlike larger CDMOs where smaller clients often struggle for attention, we provide one-on-one support, fast decision-making, and tailored solutions. Our close integration across R&D, operations, and project management ensures that customer needs are met with unmatched speed and efficiency.
Beyond expertise and responsiveness, we foster a unique level of customer engagement. Clients are not only given direct access to senior leadership but are also invited to actively participate in the manufacturing process — an opportunity rarely offered at larger CDMOs. This level of transparency and collaboration builds trust and confidence in our capabilities, reinforcing our commitment to customer success and product quality.
We also recognize that different clients require different levels of support. For smaller biotech companies with limited in-house technical expertise, we take a consultative approach, offering comprehensive project management and scientific guidance. Conversely, for larger pharma clients who already possess deep drug development knowledge but require specialized manufacturing expertise — such as in inhalation drugs or low-dose powders — we operate as an efficient, execution-focused partner.
Our ability to provide agile, highly personalized support makes Experic an ideal CDMO partner for emerging biotech and mid-sized pharma companies — ensuring they receive the attention, expertise, and flexibility they need to advance their programs efficiently and successfully.
More Than a CDMO: A True Partner in Adaptability
At Experic, flexibility is more than a promise — it’s a core part of how we operate. We integrate both macroscopic and microscopic flexibility into our approach, ensuring that our customers receive tailored solutions that adapt to their evolving needs.
One way we achieve this is through a robust network of specialized collaborators. While Experic focuses on core competencies in drug formulation, manufacturing, and device development, we leverage long-standing partnerships for complementary expertise, such as micronization, analytical testing, and other specialized services. These trusted relationships allow us to provide seamless support, accelerating timelines and maintaining the highest quality standards.
In addition to external collaborations, we continuously invest in new technologies and equipment to accommodate the unique requirements of our customers. Unlike many CDMOs that hesitate to modify their processes or infrastructure, Experic embraces innovation — whether that means adapting existing equipment, integrating new manufacturing solutions, or coordinating efforts with additional partners to streamline development.
Our commitment to adaptability extends beyond technology and infrastructure. We customize project management strategies to fit each client’s specific needs, ensuring clear communication, proactive problem-solving, and efficient execution. As new data emerges, we rapidly adjust project specifics, optimizing processes without unnecessary delays. We are also open to working collaboratively with other organizations engaged by our clients, ensuring a fully integrated development experience.
By prioritizing flexibility at every level — from strategic investments to real-time decision-making — Experic provides a seamless, agile, and customer-centric approach to pharmaceutical development and manufacturing.
Seamless GMP Integration from R&D to Clinical Production
At Experic, we bridge the gap between early-stage R&D and full-scale GMP manufacturing, ensuring a smooth transition as projects advance toward clinical and commercial production. Our ISO-8 qualified manufacturing site is equipped with the same high-quality systems across both R&D and GMP environments, allowing all feasibility batches, pilot-scale runs, and commercial manufacturing to be conducted using GMP-qualified equipment operated by highly experienced GMP-certified professionals.
While GMP regulations are often seen as restrictive, Experic’s established processes allow for flexibility in early-stage development, enabling clients to identify and address potential manufacturability challenges long before they become roadblocks. By working within a GMP framework from the outset, we help de-risk development, streamline tech transfer, and accelerate timelines — ensuring that products are both clinically and commercially viable from the earliest stages.
Beyond technical capabilities, our close-knit collaboration across R&D, manufacturing, and quality assurance teams enables an unmatched level of agility. Instead of rigid scheduling, we work backward from client milestones, such as clinical trial material availability, to optimize production timing. This proactive, goal-driven approach ensures efficiency while maintaining flexibility to accommodate unforeseen delays or accelerate timelines when needed.
By integrating GMP requirements early, fostering seamless collaboration, and offering adaptable scheduling, Experic provides clients with a nimble, risk-mitigating, and efficiency-driven manufacturing experience — helping them move from development to clinic faster and with greater confidence.
Optimizing Data Generation Without Compromising Time or Cost
In today’s competitive pharmaceutical landscape, CDMOs must strike a careful balance between generating essential development data and managing time and cost constraints — all while anticipating the evolving requirements of later clinical and commercial phases.
For example, in inhalation drug development, where dry powder formulations are increasingly common, early-stage clinical trials often utilize encapsulated powders. This approach allows for faster clinical entry and cost savings, deferring the transition to an optimized inhaled dosage form until later trials. Similarly, process yield expectations shift throughout development, as a lower yield may be entirely acceptable during early phases if it provides enough material for first-in-human studies.
At Experic, we take a phase-appropriate approach, working closely with clients to define what success looks like at each stage. Our tailored support ensures that development progresses efficiently without unnecessary expenditure or delays, all while keeping future scalability in mind to prevent costly setbacks down the line.
However, one factor is never compromised — quality. No matter the urgency or budget constraints, Experic upholds the highest safety and compliance standards, ensuring that every drug we manufacture meets rigorous quality expectations. Our commitment extends beyond our clients—to the patients who rely on safe, effective treatments in clinical trials and beyond.
Navigating the Complexities of Inhalation Drug Development
Flexibility is essential when developing inhalation products, as there are unique challenges that must be
Developing inhalation drug products requires a high degree of flexibility and expertise due to unique formulation, processing, and analytical challenges. Unlike traditional dosage forms, inhalation therapies have a limited selection of excipients, making it difficult to fine-tune formulations or address process-related issues. Only a CDMO with extensive experience across diverse inhalation products can efficiently navigate these complexities and identify the most effective solutions.
Beyond formulation challenges, the analytical methods used to assess inhalation products are inherently complex. Cascade impaction techniques, which classify particles by aerodynamic size, are highly sensitive to minor variations in test conditions, introducing potential inconsistencies. Proper interpretation of these results requires deep scientific expertise and experience. Additionally, inhalation drug development extends beyond formulation — it demands a thorough understanding of device design, assembly, and qualification. Even small variations in device components or performance can significantly impact product efficacy, adding another layer of complexity to the development process.
Particle engineering and production methods are equally critical for dry powder inhalation products. Each manufacturing approach presents unique challenges, requiring precise control over environmental factors. For example, spray-dried amorphous powders are highly sensitive to humidity, pressure, and other external conditions, necessitating rigorous environmental controls to ensure consistent performance and stability.
With inhalation products, success depends on experience, scientific precision, and adaptability — qualities that specialized CDMOs like Experic bring to every project.
Expertise in Safely Handling Highly Potent Compounds
The rise of highly potent active pharmaceutical ingredients (HPAPIs) in drug development has made low-dose powder formulations for inhalation an increasingly attractive delivery method. However, working with highly potent compounds demands specialized expertise, advanced containment solutions, and strict safety protocols. Each new project must undergo a comprehensive risk assessment to determine the necessary environmental controls, containment strategies, and operational safeguards.
At Experic, we are fully equipped to handle even the most challenging formulations safely and efficiently. Our facility features fully contained encapsulation equipment, designed to process both easy-to-fill and highly challenging formulations, including pure API at category five potency levels. To further enhance safety and flexibility, we have implemented advanced containment solutions for blending and other powder manufacturing processes, ensuring that each project benefits from the highest level of protection.
Additionally, our selection of built-in and portable isolators allows us to tailor containment strategies to meet the specific needs of each client and formulation. For projects that successfully progress to larger-scale production, we provide expert guidance on the necessary containment upgrades and are prepared to expand capacity as needed.
By combining cutting-edge technology, adaptable containment strategies, and deep expertise in handling highly potent compounds, Experic ensures both product integrity and operator safety — without compromising efficiency or scalability.
Pushing Boundaries: How Experic is Advancing Powder-Based Therapeutics
Many of the specialized technologies developed for dry powder inhalation products have applications across a wide range of drug formats. Recognizing this, Experic is actively expanding its service offerings to meet broader industry needs, leveraging its expertise in low-dose powder filling and spray drying — both critical capabilities originally developed to support inhalation drug development.
The potential applications of these technologies are extensive. Spray drying, for example, is increasingly used in the development of biologics, including proteins, and Experic is working to enhance its capabilities in this area. As industry demand grows, we remain open to new opportunities and strategic investments that align with our expertise.
Currently, Experic is equipped to handle Biosafety Level 1 materials based on the measures in place for typical pharmaceutical manufacturing. However, with the increasing interest in inhalation-based vaccine delivery, we are actively evaluating the feasibility of investing in the additional controls and procedures needed to support this area. Other areas of expansion under consideration include dry powder nasal delivery and advanced particle engineering technologies that will shape the future of inhalation-based therapeutics.
By leveraging our deep expertise in precision powder processing and exploring emerging applications, Experic is committed to remaining at the forefront of innovation while ensuring our capabilities continue to evolve with industry needs.