In pharmaceutical manufacturing, precision isn’t just preferred, it’s essential. This is especially true in capsule filling, where every microgram counts. As drug developers face increasing pressure to accelerate timelines and reduce costs, capsule filling has emerged as a critical process that directly impacts product quality, patient safety, and clinical success.
At Experic, capsule filling is a scientific discipline built on advanced technology, powder expertise, and a commitment to precision.
What Is Capsule Filling?
Capsule filling is the process of dosing precise quantities of pharmaceutical powders, pellets, or granules into a hard or soft gelatin capsule. This step must achieve uniformity, prevent cross-contamination, and maintain the integrity of the Active Pharmaceutical Ingredient (API). Especially for low-dose or high-potency products, even minor deviations can have significant implications for efficacy and safety.
Modern capsule filling technologies must accommodate a range of formulation types, including cohesive powders and spray-dried dispersions, while supporting scalability from early-phase clinical trials through commercial production.
Why Precision Matters in Capsule Filling
Capsule filling plays a pivotal role in achieving dose uniformity—a requirement for regulatory compliance and therapeutic effectiveness. With precision low-dose applications, the need for scientific rigor becomes even more pronounced. Experic’s capsule filling services are built to deliver this precision, powered by Harro Höfliger equipment and deep powder handling expertise.
Unlike more generalized Contract Development and Manufacturing Organizations (CDMOs), Experic specializes in challenging powder formulations, including those with electrostatic properties or flowability issues. This expertise translates into:
- Reduced variability in fill weights
- Minimized product loss and wastage
- Improved batch consistency and reproducibility
Learn more about our drug product manufacturing capabilities and how we ensure the highest standards for precision-driven production.
The Technology Behind Modern Capsule Filling
Experic’s state-of-the-art, purpose-built 73,000 sq. ft. facility was designed to tackle the most demanding capsule filling projects. Our equipment portfolio includes automated capsule fillers that can handle a wide range of dosages and powder characteristics, ensuring precise and consistent filling.
Features include:
- Dosing wheel systems for consistent volumetric filling
- Tamping-style mechanisms for low-dose uniformity
- Real-time monitoring for fill weight verification and quality control
This technology ensures that every capsule is filled accurately, efficiently, and in compliance with current Good Manufacturing Practice (cGMP) standards.
How Capsule Filling Enhances Drug Development Timelines
Capsule filling is not only about accuracy, but it also supports speed and efficiency. By optimizing fill parameters during early-stage development, manufacturers can minimize formulation rework and accelerate the path to clinical trials. This alignment between development and manufacturing saves valuable time and resources.
Experic’s integrated approach, spanning formulation development to packaging and logistics, streamlines the drug development process and helps sponsors meet critical milestones faster.
Our ability to quickly adapt to evolving project needs, whether in R&D, clinical, or commercial phases, enables faster onboarding and smoother scale-up. This is especially important when transitioning from small-batch clinical supply to larger-scale commercial manufacturing.
Capsule Filling and Dry Powder Inhalation (DPI)
For products delivered via inhalation, capsule filling becomes more complex. These formulations must be filled with high precision to ensure accurate dose delivery through a device. Experic’s expertise in dry powder inhalation (DPI) makes us a trusted partner for drug-device combination products.
We handle everything from spray-dried dispersions to lactose-blended formulations, applying specialized knowledge to optimize fill weights and dispersion performance.
Regulatory Considerations for Capsule Filling
Regulatory bodies, such as the FDA and EMA, have stringent requirements for content uniformity, fill weight tolerance, and validation procedures. At Experic, our capsule filling processes are built to exceed these expectations.
We utilize in-process controls, automated data collection, and thorough documentation practices to ensure every batch meets regulatory standards. Our analytical and quality assurance teams collaborate closely with clients to navigate audits and prepare for successful submissions.
The Experic Difference
What sets Experic apart in capsule filling is not just our technology, but our mindset. We’re scientists, engineers, and collaborators with a deep understanding of CMC challenges. Whether it’s developing a formulation for a high-potency oncology drug or scaling up a pediatric microdose therapy, our team brings unmatched expertise to the table.
Experic also offers a unique benefit, seamless integration of manufacturing with clinical packaging and supply chain management. This end-to-end model reduces handoffs, minimizes risk, and ensures continuity from the production floor to the patient.
Discover our clinical packaging and supply services to learn how we support clients throughout every step of the trial process.
Accurate Dosing, Faster Development, and Greater Confidence
Capsule filling may seem like a straightforward task, but behind each capsule lies a complex intersection of science, engineering, and regulatory compliance. Done right, it enables accurate dosing, faster development, and greater confidence in your product’s performance.
At Experic, capsule filling is a cornerstone of our CDMO services. Our clients rely on us to deliver accuracy, agility, and insight at every stage of development. From challenging powders to low-dose precision, we’re here to fill the gaps in your manufacturing journey.
Partner with Experic today to bring your capsule filling program to life with speed, precision, and scientific integrity.