Piramal Pharma Solutions Inc., 1500 Bull Lea Road, Suite 250, Lexington, KY 40511
Piramal’s Lexington, KY site specializes in the formulation development and manufacturing of Sterile Injectables, offering sterile compounding, fill/finish, and lyophilization capabilities. The facility is equipped with in-house analytical, microbiological, formulation development, and manufacturing services, spanning from preclinical to clinical and commercial stages.
The site possesses extensive experience and proficiency across the complexity scale ranging from simple liquid, lyophilized (both Aqueous & Co-solvent based) formulations to complex drugs products such as Liposomal, Nano-emulsions, Nanoparticle suspensions and Anti-body Drug Conjugates (ADCs). Major regulatory accreditations include USFDA, PMDA, TFDA and Saudi Food and Drug Authority.
We have vast experience in enhancing the solubility of poorly soluble drugs and improving their bioavailability. We have supported clients with pre-formulation, prototype screening, lead identification, and process optimization. We have developed formulations applying Quality by Design (QbD) principles and Design of Experiment (DOE) studies. We have also performed lyophilization cycle development, material compatibility studies, filter selection, and in-use solution stability studies.
Our manufacturing facility offers comprehensive manufacturing services for sterile injectable drug products, utilizing 100% isolator-based fill/finish technology. In addition to compounding, we provide terminal sterilization services for enhanced product sterility. Our focus on product integrity includes full cold chain, gas overlay, and light protection, supporting clinical and commercial production of liquid and lyophilized formulations.
We have vast experience in enhancing the solubility of poorly soluble drugs and improving their bioavailability. We have supported clients with pre-formulation, prototype screening, lead identification, and process optimization. We have developed formulations applying Quality by Design (QbD) principles and Design of Experiment (DOE) studies. We have also performed lyophilization cycle development, material compatibility studies, filter selection, and in-use solution stability studies.
Our manufacturing facility offers comprehensive manufacturing services for sterile injectable drug products, utilizing 100% isolator-based fill/finish technology. In addition to compounding, we provide terminal sterilization services for enhanced product sterility. Our focus on product integrity includes full cold chain, gas overlay, and light protection, supporting clinical and commercial production of liquid and lyophilized formulations.
Utilizing isolator-based technology, our facility ensures stringent containment for handling various pharmaceutical products with very low Occupational Exposure Limit (OEL) values, including high potency APIs, cytotoxic agents, hormones, and steroids. We offer vial capabilities ranging from 2 mL to 100 mL for liquid products and from 2 mL to 50 mL for lyophilized products. Our isolators are cleaned with product-specific cleaning methods, sanitized, and decontaminated with qualified Vaporized Hydrogen Peroxide (VHP) cycles. Once materials and components are sterile, they remain within the isolator until the primary container is sealed.
Our site features advanced lyophilization capabilities to meet diverse client needs. We are experienced in co-solvent-based lyophilization, determining the optimal aqueous/organic ratio to enhance solubility. With two pilot-scale 6.4 ft² SP Scientific LyoStar Lyophilizers and one manufacturing-scale 48 ft² Hull Lyophilizer, we offer flexible scale options. Lyophilization cycle development is tailored to each formulation’s unique thermal properties, ensuring shorter lyo cycles, optimal efficiency, and stability.
Our core expertise lies in working with highly potent drugs like cytotoxics, steroids, and acutely toxic substances. Utilizing mobile isolator technology, we ensure staff safety by enclosing products in a Grade A environment. Standard Operating Procedures (SOPs) and Occupational Exposure Limits (OELs), determined by certified toxicologists, guide our handling processes. Fixed isolators in our development labs enable formulation and analytical development on toxic substances, reflecting our commitment to safety and capability in handling potent compounds.
We specialize in complex multi-step/multi-day formulations, with rigorous in-process testing to ensure maximum encapsulation, correct particle size distribution, optimal lipid concentration, and low bioburden. Our batch size capabilities range from small (<50L) to large (>500L), and we can conduct extended campaign-style batches on our commercial-grade Steriline Filling Line. With a track record of completing multiple clinical and late-phase projects, we possess advanced technology expertise in large-scale extrusion, microfluidization, tangential flow filtration (TFF), rotary evaporation, and complex filtration techniques.
Our state-of-the-art analytical labs support cGMP manufacturing and specialize in analytical technology transfer, method qualification, and validation. We ensure meticulous quality control throughout your project lifecycle.
The facility supports Piramal's fully integrated ADC Solution, ADCelerate: Development and Manufacturing of payload-linker, mAbs, and ADC.
Robust reputation for technical expertise spanning a wide spectrum of complexities. Our team excels in formulating diverse solutions, from simple liquids to complex ADCs and nanoparticle suspensions
Lexington is a Grade A isolator-based facility with potent drug product capabilities. We follow the “Protecting the product, protecting the people” value system
Embracing a culture of quality, we integrate rigorous quality checks throughout operations to ensure consistent and exceptional product quality in sterile development and manufacturing. Highest quality standards are upheld at every stage of the process.
Successful completion of the first USFDA inspection
Business was acquired by Piramal from Coldstream Laboratories
Expansion of capacity with a $25M investment, installing a new high-speed vial filling line
5th FDA Approval for manufacturing
Lexington site is established by Coldstream Laboratories
