Non-Sterile Liquids
Balancing Complexity and Control for Non-Sterile Liquid Drug Products
Non-sterile liquid drug products, such as solutions, suspensions, nasal sprays, and topical sprays, offer dosing flexibility, rapid API delivery, and patient-friendly administration, but they are challenging to develop and manufacture. API solubility, physical-chemical stability, microbial control, palatability, and container–closure compatibility must all be balanced without sacrificing shelf life or dose uniformity. CPL brings 35 years of focused experience designing and scaling non-sterile liquids that are robust, reproducible, and GMP-ready, from early formulation through clinical and commercial manufacturing.
Integrated Non-Sterile Liquids Development and GMP Manufacturing
As a pure-play CDMO specializing in non-sterile liquid drug products, including suspensions, solutions, nasal sprays, and topical sprays, we bring deep expertise in solving API solubility and stability challenges, selecting optimal vehicles and excipients, and tightly controlling dose uniformity, physical-chemical stability, and microbial risk from the earliest stages of development.
Formulation & Analytical Expertise
CPL’s formulation and analytical teams collaborate from the earliest phases, using Design of Experiments, robust analytical method development, and ICH-aligned method validation to create liquid formulations that are both effective and tightly controlled. Further enhancing our expertise in formulating and manufacturing non-sterile liquids is our team’s extensive experience with challenging suspensions that require careful management of particle size, dispersibility, and physical stability to ensure reliable performance and predictable shelf life.
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Manufacturability, Process Development & Tech Transfer
Process development supporting manufacturability is embedded from the beginning of every program. We systematically link Critical Process Parameters (CPPs) to Critical Quality Attributes (CQAs) and fine-tune parameters to design processes that scale smoothly from lab to commercial production. For tech transfer, we de-risk every step through structured gap and risk assessments, targeted lab and pilot batches, and focused compatibility and scale-up studies.
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Non-Sterile Liquid Suspensions
Our team excels in formulating and manufacturing non-sterile liquid suspensions with uniform dispersion, physical stability, and dose consistency. We address common challenges such as sedimentation, caking, and dose uniformity through precise ingredient selection, optimized wetting, flocculation strategies, and a robust homogenization process. Our facilities support GMP-compliant production with rigorous in-process controls for viscosity, pH, and particle size. From formulation through packaging, CPL ensures safe, effective, and re-dispersible suspensions tailored to patient needs and regulatory standards.
Non-Sterile Liquids Clinical & Commercial Manufacturing
CPL’s 140,000 ft2 GMP manufacturing facility supports the production of clinical and commercial suspensions and solutions from 20kg to 5,000kg, with integrated packaging capabilities. We produce GMP clinical, registration, and commercial batches of liquid drug products that are scientifically sound, scalable, and supply chain-ready. In addition to exceptional product quality, we pride ourselves on our OTIF (on-time, in-full) delivery.
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Packaging, Labeling & Serialization
CPL is more than just another bulk drug product manufacturer. Our packaging, labeling, serialization, and aggregation services, paired with our extensive manufacturing capacity, deliver turnkey solutions that boost efficiency, reduce risk, and ensure full compliance with traceability requirements.
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Low-Dose Oral Suspension with Uniform Dose Accuracy
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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Non-sterile suspensions contain dispersed solid particles that tend to settle, agglomerate, or cake over time, threatening dose uniformity. Formulators must carefully control particle size distribution, wetting, density, and viscosity to maintain drug dispersibility throughout shelf life, while also managing chemical stability, taste, and microbial control without terminal sterilization. These interdependent variables make robust suspension design and scale-up technically challenging.
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In a solution, the API is fully dissolved in the vehicle, resulting in a single-phase system with the drug dissolved throughout the vehicle. In a suspension, the API remains as solid particles dispersed in the liquid, forming a two-phase system that requires shaking to redisperse before dosing. As a result, suspensions are more prone to settling and are generally harder to keep physically stable than solutions.
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CPL links Critical Process Parameters (CPPs), such as mixing speed/time, order, and rate of API and excipient addition, homogenization parameters, and hold temperatures, to Critical Quality Attributes (CQAs) such as particle size, redispersibility, and dose uniformity. Through Design of Experiments, lab and pilot batches, and scale-down models, we map a robust design space before moving to commercial volumes, reducing the risk of sedimentation, caking, or variability at scale.
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Non-sterile liquids must meet stringent microbiological quality standards even though they are not sterile. CPL designs preservative systems based on pH, water activity, and packaging, and verifies their performance with pharmacopeial preservative efficacy tests. We also implement product quality-enhancing practices, such as cleanroom operations that meet GMP standards, water quality protocols, environmental monitoring, packaging, and container–closure selection, to minimize bioburden while maintaining product safety and shelf life.
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.
