Manufacturability & Process Development
From Promising Formulation to Proven Manufacturing Processes
All too often, innovative semi-solid or non-sterile liquid drug products show therapeutic promise in early-phase development, but the manufacturing processes utilized at bench scale are onerous, inefficient, and generally insufficient for commercial-scale production. CPL considers commercial manufacturability and scalability from the very start of product development, because even if a formulation is efficacious, it has limited value if it cannot be manufactured efficiently and effectively to supply the market.
Extensive Experience Tackling Process Development Challenges
True expertise means more than knowing how to address common challenges; it means anticipating them early, engineering to avoid them, and delivering robust processes from the bench to commercial lines. For non-sterile liquid and semi-solid process development, proactively addressing hurdles determines the success of a product’s development journey.
Common challenges addressed by the CPL team include:
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Microbial risk is tightly managed to protect patients and product shelf life. This includes controlling bioburden, proving preservative effectiveness, and maintaining disciplined environmental monitoring throughout manufacturing processes.
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Solutions, suspensions, emulsions, gels, and ointments are inherently complex. Our team achieves the right balance of solubility, viscosity, and long-term physical stability, and, in many semi-solids, addresses rheological challenges that require deep formulation and process know-how.
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Maintaining chemical, physical, and microbiological stability over time can be challenging due to phase separation, sedimentation or caking, pH drift, preservative degradation, and packaging interactions, such as leachables and adsorption.
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What works in a beaker can fail in a 500-L vessel. Mixing and homogenization performance, shear sensitivity, thermal exposure, equipment fit, and batch-to-batch reproducibility are engineered with an eye for efficient commercial production from the start.
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Success for our CDMO clients also depends on meeting evolving standards, such as USP <795> for non-sterile compounding and cGMP requirements. CPL ensures compliance through rigorous documentation, traceability, master work order control, and ongoing operator training and competency validation.
CPL Experience Spotlight
CPL Experience Spotlight: Non-Sterile Liquid Suspension Dose Uniformity
Dedicated to Excellence
from Molecule to Commercialization
CPL supports programs from early-phase through commercial launch, combining preformulation insight, robust semi-solid and non-sterile liquid development, scalable process design, and clinical and commercial manufacturing.
Pharmaceutical Development Services
Pharmaceutical Development Services
Comprehensive expertise that turns molecules into scalable, compliant, market‑ready semi-solid and non-sterile therapies.
Analytical & Product Testing
Analytical & Product Testing
Robust analytics power confident development and manufacture of topical and non-sterile liquid products.
Clinical & Commercial Manufacturing
Clinical & Commercial Manufacturing
More than three decades of GMP manufacturing experience from clinical supply through commercialization.
Packaging, Labeling & Serialization
Packaging, Labeling & Serialization
Integrated packaging, serialization, and aggregation ensure compliant, continuous commercial supply.
Semi-Solid & Non-Sterile Liquid Expertise
Semi-Solid & Non-Sterile Liquid Expertise
Pure-play CDMO for semi-solids and non-sterile liquids, with advanced micro encapsulation capabilities.
Unique Product Handling Experience
Unique Product Handling Experience
Infrastructure and expertise to manage complex, higher-risk semi-solid and non-sterile liquid products.
FAQs
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Semi-solid and non-sterile liquid drug products are often complex systems, like emulsions, suspensions, gels, and ointments, whose performance depends on tightly controlled rheology, particle size, and microstructure. Small changes in mixing, shear, or heat transfer can trigger phase separation, sedimentation, or Ostwald ripening in suspensions, jeopardizing content uniformity and stability. At the same time, manufacturers must control microbial contamination, preservative effectiveness, and interactions with packaging and the container-closure system. These complexities make robust process design and ongoing monitoring essential in modern pharmaceutical manufacturing.
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CPL uses a QbD (Quality by Design)-driven approach, aligning with critical regulatory guidances to build quality and manufacturability into the process from day one. Our scientists and process engineers characterize formulation behavior at lab and pilot scale, then apply tools such as risk assessments, FMEA, and DoE (Design of Experiments) to map the design space. For topical and other semi-solid products, we incorporate SUPAC-SS expectations and, where appropriate, IVRT/IVPT data to link formulation, process parameters, and product performance. The result is manufacturable, scalable processes that transfer smoothly into cGMP manufacturing.
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The FDA defines process validation as the collection and evaluation of data from process design through commercial production to show that a process can consistently deliver a quality product. Current guidance uses a lifecycle model with three stages: process design, process qualification (including PPQ batches), and process validation. For semi-solid and non-sterile liquid manufacturing, CPL designs validation strategies around critical quality attributes and critical process parameters, ensuring statistically sound PPQ, robust documentation, and inspection-ready pharmaceutical process validation.
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Before scaling up, key equipment, like mixers, high-shear homogenizers, fillers, and packaging lines, undergoes Installation, Operational, and Performance Qualification (IQ/OQ/PQ) to verify that it is installed correctly, operates within defined ranges, and performs consistently under process conditions. This equipment qualification in the pharmaceutical industry is tightly linked to process design and PPQ, following the FDA’s three-stage validation lifecycle. At CPL, we combine IQ/OQ/PQ with scale-down and scale-up studies to ensure that changes in vessel size, geometry, shear, and heat transfer do not compromise the quality of semi-solid or liquid products during technology transfer and commercial manufacturing.
Commitment.
Partnership. Legacy.
Leverage CPL’s 35 years of expertise in non-sterile liquids and semi-solids to ensure your program's success. We’ll support your product from molecule to market, or step in at any stage of its product lifecycle.
