Unique Product Handling Experience
Specialized Handling for Hormones, Alcohol-Containing & High-Potency Products
CPL is equipped to manage complex, higher-risk semi-solid and non-sterile liquid products, including male and female hormones, corticosteroids, alcohol-containing, light-sensitive, and select high-potency compounds. Dedicated suites and equipment, XP-rated environments for alcohol products, and contained isolators for male and female hormones, as well as Safebridge category 3 APIs, help protect patients and personnel. Robust PPE, engineered air handling, and disciplined procedures ensure compliant, segregated manufacturing without compromising quality or cross-contamination control.
Controlled Containment & Manufacturing for High-Risk Products
Explore our specialized manufacturing and containment capabilities for challenging drug products, including hormones, corticosteroids, HPAPIs (high-potency active pharmaceutical ingredients), alcohol-based formulations, and light-sensitive compounds, ensuring safety, compliance, and product integrity at every step.
Male & Female Hormone Handling Expertise
CPL offers specialized capabilities for the handling and manufacturing of hormone-based drug products, including both male and female hormones, a somewhat rare and differentiating capability in the semi-solid CDMO space. Dedicated suites and equipment are used to prevent cross-contamination, with separate areas for male and female hormone products. For high-potency compounds like estradiol, CPL uses negative-pressure isolators to ensure containment and operator safety, while maintaining strict environmental controls in line with cGMP, ISO, and other regulatory expectations.
High-Potency API (HPAPI) Management
We are equipped to safely manage highly potent compounds, including Category 3 APIs per Safebridge classification. Handling is performed under containment using negative pressure isolators (glove boxes) to prevent operator exposure. Staff wear full PPE (personal protective equipment), including Tyvek® suits, gloves, and powered air-purifying respirators (PAPRs). Dedicated suites feature independent air handling systems and stringent engineering controls to minimize cross-contamination and ensure cGMP-compliant handling of high-potency drug substances.
Alcohol-Based Product Manufacturing Capabilities
Our GMP facility is equipped to safely manufacture alcohol-containing semi-solid and liquid drug products in dedicated explosion-proof (XP-rated) suites designed for flammable solvents. All processing equipment is XP-rated and grounded in accordance with regulatory safety standards to mitigate ignition risks. Dedicated storage areas ensure compliant handling and inventory management of ethanol and other volatile solvents. With robust safety protocols, specialized infrastructure, and proven expertise, CPL supports formulation, scale-up, and packaging of alcohol-based products with confidence and regulatory compliance.
Light-Sensitive Semi-Solid & Non-Sterile Liquid Manufacturing
CPL is equipped to manufacture and package light-sensitive semi-solid and liquid drug products under controlled lighting conditions to prevent photodegradation. Specialized production suites utilize yellow lighting, UV-filtered fixtures, and light-restrictive packaging to protect product integrity during processing and storage. From formulation through final packaging, CPL follows strict cGMP protocols for light-sensitive APIs, ensuring compliance with regulatory requirements and preserving the stability, safety, and efficacy of finished drug products throughout the product lifecycle.
CPL Experience Spotlight
Safely Scaling an Alcohol-Based Product
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
-
CPL has the rare ability to manufacture both male and female hormone-based drug products, as well as a variety of corticosteroids. Dedicated suites and equipment are used for each hormone type to prevent cross-contamination. Estradiol products, due to their high potency, are handled under containment using negative-pressure isolators. Strict cleaning validation, personnel controls, and segregated workflows support compliance and product integrity.
-
Alcohol-containing semi-solids and non-sterile liquids are manufactured in intrinsically safe (XP-rated) suites using XP-rated equipment. Grounding procedures are strictly followed to prevent static discharge and ignition risks. CPL also maintains dedicated, compliant storage areas for flammable solvents such as ethanol, ensuring full compliance with safety and regulatory guidelines.
-
For compounds classified as Category 3 under Safebridge standards, CPL utilizes negative-pressure isolators (glove boxes) to weigh and wet APIs under containment. Personnel are equipped with Tyvek® suits, gloves, and powered air-purifying respirators (PAPRs), while dedicated suites feature independent air-handling systems to minimize cross-contamination and protect operator safety, in accordance with cGMP.
-
CPL employs controlled lighting environments, including yellow light and UV-filtered fixtures, to protect light-sensitive APIs from photodegradation. Packaging processes use light-restrictive materials to maintain stability at every stage, from formulation through final packaging, in alignment with cGMP standards to ensure the safety, efficacy, and shelf life of these products.
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.
